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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG022845 | U.S. NIH Grant/Contract | View source | |
| 5U24AG058556 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Cornell University | OTHER |
| Wake Forest University | OTHER |
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Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.
The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).
Specific Aims:
Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.
Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.
For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LARKSPUR intervention | Experimental | Lessons in Affect Regulation to Keep Stress and Pain UndeR control |
|
| Attention Control Condition | No Intervention | Daily emotion reporting/no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LARKSPUR | Behavioral | This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment as Measured by Rates of Enrollment (Aim 1) | Percent enrolled of total eligible participants. | At baseline |
| Retention as Measured by Change in Enrollment | Percentage enrolled at baseline that completed the post-intervention assessment. | At baseline; at week 11 (post-intervention) |
| Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) "Would you recommend LARKSPUR to a friend?" and (2) "Would you recommend LARKSPUR to someone else with chronic pain?". Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined. | At week 11 (post-intervention) |
| Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1) | Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program. | At week 11 (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Positive affective reactivity measured by the modified Differential Emotions Scale (mDES). Upon completion of each study assessment, participants completed the mDES daily for one week, for a total of three 7-day-long periods. The mDES is a 20-item instrument that measures the extent to which a patient has experienced positive (10 items) and negative (10 items) emotions over a chosen time frame; in the version used in this survey, we ask for emotions over the past 24 hours. Respondents are asked to report the greatest amount of positive affect on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores were computed over the 10 items, ranging from 0 (not at all positive) to 4 (extremely positive). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Ong, PhD | Cornell University | Principal Investigator |
| Cary Reid, MD PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork-Presbyterian - Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35964867 | Background | Ong AD, Moskowitz JT, Wethington E, Addington EL, Sanni M, Goktas S, Sluys E, Swong S, Kim P, Reid MC. Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia. Contemp Clin Trials. 2022 Sep;120:106880. doi: 10.1016/j.cct.2022.106880. Epub 2022 Aug 11. | |
| 39657168 | Derived | Ong A, Wilcox K, Reid MC, Wethington E, Cintron D, Addington E, Goktas S, Moskowitz J. Targeting Daily Positive Events to Improve Emotional and Functional Well-Being in Adults With Fibromyalgia: Insights From the LARKSPUR Randomized Controlled Trial. J Med Internet Res. 2024 Dec 10;26:e54678. doi: 10.2196/54678. |
| Label | URL |
|---|---|
| This manuscript describes the study design and anticipated analyses for this trial. | View source |
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Reduced, de-identified data sets containing data collected from patients, will be made available for secondary use at the National Archive of Computerized Data on Aging (NACDA), a division of ICPSR at the University of Michigan. NACDA is a repository of survey data on aging that has hundreds of social science research data sets available that are drawn from NIA-funded surveys and data collection efforts. NACDA has established protocols for contributors to reliably de-identify survey participants, regardless of whether they have been assembled as part of national random sample surveys or specialized registry data collection efforts. External users may be asked to provide study aims, variables requested, analytic plans, and targeted journals in their data use requests. They will also be asked to not attempt to re-identify participants, either by merging in administrative, census, medical, or other data, or by using a software program that might re-identify participants.
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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142 participants were recruited for the study and assessed for eligibility. Of those 142 participants, n = 22 did not meet eligibility requirements. Of the n = 120 eligible participants, n = 22 declined to participate, n = 2 were excluded by the investigators, and n = 1 was unable to access the online study platform; 95 participants met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | LARKSPUR Intervention | Lessons in Affect Regulation to Keep Stress and Pain UndeR control LARKSPUR: This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention. |
| FG001 | Attention Control Condition | Daily emotion reporting/no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LARKSPUR Intervention | Lessons in Affect Regulation to Keep Stress and Pain UndeR control LARKSPUR: This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment as Measured by Rates of Enrollment (Aim 1) | Percent enrolled of total eligible participants. | 120 of 142 participants recruited for the study who met eligibility requirements. | Posted | Count of Participants | Participants | At baseline |
|
|
Through study completion, an average of 4 months per participant.
This was an on-line behavioral intervention with assessments also done remotely. The study was deemed minimal risk to participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LARKSPUR Intervention | Lessons in Affect Regulation to Keep Stress and Pain UndeR control LARKSPUR: This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Ong | Cornell University | 6072559993 | anthony.ong@cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 10, 2022 | Apr 4, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2023 | Mar 3, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2021 | Mar 3, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes. | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes. | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes. | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. CESD-R-10 mean scores range from 0 (rare depressive symptoms) to 4 (depressive symptoms most or almost all the time). | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores range from 0 (not at all experienced positive emotion) to 4 (extremely positive emotion). | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. PANAS-GEN mean scores range from 0 (very slightly or not at all positive affect) to 4 (extremely positive affect). | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress). | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
| At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) |
| Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Affective reactivity to stress measured by the Daily Inventory of Stressful Events (DISE). Upon completion of each study assessment, patients completed the DISE daily for one week, for a total of three 7-day-long periods. The DISE is a 7-item self-report instrument in which participants report whether stressful events (argument, work or school stress, home stress, discrimination, close friend stress, other stressors) have occurred within the past 24 hours, indicating "yes" or "no" accordingly for each item. Item scores are averaged, ranging from 0=no stress to 1=highest stress. Higher scores indicate worse outcomes. | At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) |
| 38094931 | Derived | Ong AD, Wilcox KT, Moskowitz JT, Wethington E, Addington EL, Sanni MO, Kim P, Reid MC. Feasibility, Acceptability, and Preliminary Efficacy of a Positive Affect Skills Intervention for Adults With Fibromyalgia. Innov Aging. 2023 Jul 13;7(10):igad070. doi: 10.1093/geroni/igad070. eCollection 2023. |
| BG001 | Attention Control Condition | Daily emotion reporting/no intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PROMIS Pain Intensity - Short Form 3a | Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes. | Mean | Standard Deviation | T-score |
|
| PROMIS Pain Interference - Short Form 6b | Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes. | Mean | Standard Deviation | T-score |
|
| PROMIS Physical Functioning Short Form 10a | Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes. | Mean | Standard Deviation | T-score |
|
| PROMIS Fatigue - Short Form 6a | Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes. | Mean | Standard Deviation | T-score |
|
| Depressive Symptoms (Center for Epidemiologic Studies Depression Scale Revised, CESD-R-10) | The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. Mean scores range from 0.0 (rare depressive symptoms) to 3.0 (depressive symptoms most or almost all of the time). | Mean | Standard Deviation | units on a scale |
|
| Positive Affect (modified Differential Emotions Scale, mDES) | The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. Mean scores range from 0.0 (not at all experienced positive emotion) to 4.0 (extremely positive emotion). | Mean | Standard Deviation | units on a scale |
|
| Positive Affect (Positive and Negative Affect Scale, PANAS-GEN) | The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. Mean scores for the 10-item Positive Affect subscale range from 0.0 (very slightly or not at all positive affect) to 4.0 (extremely positive affect). | Mean | Standard Deviation | units on a scale |
|
| Stress Appraisal (Perceived Stress Scale) | The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress). | Mean | Standard Deviation | units on a scale |
|
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| Primary | Retention as Measured by Change in Enrollment | Percentage enrolled at baseline that completed the post-intervention assessment. | Posted | Count of Participants | Participants | At baseline; at week 11 (post-intervention) |
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| Primary | Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) "Would you recommend LARKSPUR to a friend?" and (2) "Would you recommend LARKSPUR to someone else with chronic pain?". Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11. For the Attention Control condition, n = 3 lost to follow-up at Week 11. | Posted | Least Squares Mean | Standard Error | units on a scale | At week 11 (post-intervention) |
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| Primary | Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1) | Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11. n = 3 participants did not complete all skills in the LARKSPUR intervention and are excluded from analysis. Attention Control group are not analyzed because they did not receive the LARKSPUR intervention. | Posted | Median | Inter-Quartile Range | weeks | At week 11 (post-intervention) |
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| Secondary | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | T-score | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | T-score | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | T-score | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | T-score | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. CESD-R-10 mean scores range from 0 (rare depressive symptoms) to 4 (depressive symptoms most or almost all the time). | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores range from 0 (not at all experienced positive emotion) to 4 (extremely positive emotion). | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. PANAS-GEN mean scores range from 0 (very slightly or not at all positive affect) to 4 (extremely positive affect). | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Secondary | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress). | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Other Pre-specified | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Positive affective reactivity measured by the modified Differential Emotions Scale (mDES). Upon completion of each study assessment, participants completed the mDES daily for one week, for a total of three 7-day-long periods. The mDES is a 20-item instrument that measures the extent to which a patient has experienced positive (10 items) and negative (10 items) emotions over a chosen time frame; in the version used in this survey, we ask for emotions over the past 24 hours. Respondents are asked to report the greatest amount of positive affect on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores were computed over the 10 items, ranging from 0 (not at all positive) to 4 (extremely positive). | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| Other Pre-specified | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Affective reactivity to stress measured by the Daily Inventory of Stressful Events (DISE). Upon completion of each study assessment, patients completed the DISE daily for one week, for a total of three 7-day-long periods. The DISE is a 7-item self-report instrument in which participants report whether stressful events (argument, work or school stress, home stress, discrimination, close friend stress, other stressors) have occurred within the past 24 hours, indicating "yes" or "no" accordingly for each item. Item scores are averaged, ranging from 0=no stress to 1=highest stress. Higher scores indicate worse outcomes. | For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Attention Control Condition | Daily emotion reporting/no intervention | 0 | 46 | 0 | 46 | 0 | 46 |
Not provided
Not provided
| Week 11 (Post-Intervention) |
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| Week 16 (1 month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.732 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 0.44 | Standard Error of the Mean | 1.29 | 2-Sided | 95 | -2.12 | 3.00 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.609 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 0.71 | Standard Error of the Mean | 1.38 | 2-Sided | 95 | -2.05 | 3.47 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.209 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 1.38 | Standard Error of the Mean | 1.09 | 2-Sided | 95 | -0.78 | 3.54 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.063 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 2.21 | Standard Error of the Mean | 1.17 | 2-Sided | 95 | -0.12 | 4.54 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.209 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 1.20 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -0.69 | 3.09 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.151 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 0.95 | Standard Error of the Mean | 0.66 | 2-Sided | 95 | -0.35 | 2.26 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.269 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -1.65 | Standard Error of the Mean | 1.49 | 2-Sided | 95 | -4.60 | 1.29 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.116 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | -2.43 | Standard Error of the Mean | 1.53 | 2-Sided | 95 | -5.47 | 0.61 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.126 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 0.13 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.04 | 0.29 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.457 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 0.07 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.12 | 0.25 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.157 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 0.19 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.07 | 0.46 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.593 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 0.08 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.21 | 0.36 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.642 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.19 | 0.31 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.577 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 0.07 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.18 | 0.32 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.062 | The threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -0.21 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.44 | 0.01 | The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control. | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.269 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | -0.12 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.33 | 0.09 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline). |
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.006 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | 0.18 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | 0.05 | 0.31 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline). | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.796 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | -0.02 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.15 | 0.12 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |
| Week 11 (Post-Intervention) |
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| Week 16 (1 Month Post-Intervention) |
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The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline). |
| Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.880 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | -0.00 | Standard Error of the Mean | 0.02 | 2-Sided | 95 | -0.04 | 0.04 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline). | Superiority |
| The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses. | Mixed Models Analysis | Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method. | 0.652 | The threshold for statistical significance was 0.05. | Mean Difference (Net) | -0.01 | Standard Error of the Mean | 0.02 | 2-Sided | 95 | -0.05 | 0.03 | The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11). | Superiority |