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The purpose of the proposed project is to develop and test how well an internet-based behavioral pain self-management program, the Pain EASE program, can be used for treating low back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain EASE program will also be examined. Behavioral interventions such as exercise and cognitive behavior therapy are known to be effective for low back pain but are often not readily available or easily accessed. Veterans will be able to access the Pain EASE program via their computer with an internet connection, which will increase access to this type of treatment. Study participants will receive 10 weeks of access to the Pain EASE program, which will teach them pain coping skills to manage their low back pain. The primary outcome is pain-related functional interference.
OBJECTIVES: The primary objectives of the proposed study are to: (1) develop an integrative, Internet-based, Veteran-centered behavioral intervention, the Pain EASE program for chronic low back pain (CLBP), and (2) examine preliminary efficacy, usability, and satisfaction of this intervention in a representative sample of Veterans with CLBP. The primary hypothesis states that a clinically meaningful reduction in pain-related functional interference will be observed following ten weeks of exposure to the Pain EASE program relative to baseline. The secondary hypotheses state that clinically meaningful reductions in ratings of average pain intensity on a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale at the ten week post-baseline follow-up assessment interval will be observed, in addition to statistically significant reductions in fatigue, sleep problems, depressive symptoms, and negative mood at the ten week post-baseline assessment. The tertiary hypotheses state that participants will report high levels of interest, site usage, and satisfaction.
RESEARCH DESIGN: A non-randomized pilot study with two phases is proposed to develop and evaluate an internet-based behavioral pain self-management program. Phase I will solely involve qualitative data collection. Repeated quantitative assessments during Phase II will be conducted at baseline and 10-weeks post-baseline.
METHODOLOGY: A 24-month pilot study with two phases is proposed. During Phase I, the Pain EASE program will be developed and feedback from 15 Veterans with CLBP and an Expert Panel of pain management clinicians will be used to modify the program. During Phase II, a pilot feasibility trial of the Pain EASE program with 55 Veterans with CLBP will be conducted. Subjects will be a total of 70 patients receiving care at the VA Connecticut Healthcare System (VACHS) who report chronic low back pain. The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain (i.e., scores of 4 or greater on a 0 [no pain] to 10 [worst pain imaginable]) on a numerical rating scale of pain and indication of the "preparation", "action", or "maintenance" stage of readiness to change on a brief five item staging checklist. All patients must have access to a computer with an internet connection. Excluded will be patients with life threatening or acute physical illness, current alcohol or substance abuse or dependence, current psychosis, suicidal ideation, dementia, and individuals seeking surgical pain treatment. All participants will continue to receive their usual care from Veterans Health Administration (VHA) providers. During the 10-week therapeutic window, weekly telephone calls from research staff will serve to cue and monitor participants' use of the Internet program. At ten weeks post-baseline, participants will be formally reassessed. Primary and secondary hypotheses involving quantitative data will be analyzed using an intent-to-treat principle and will employ t-tests and non-parametric analogs and regression analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 week Pain EASE access | Experimental | behavioral pain self-management intervention (Pain EASE) delivered via the Internet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral pain self-management intervention Pain EASE | Behavioral | 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing |
| Measure | Description | Time Frame |
|---|---|---|
| Multidimensional Pain Inventory Interference Subscale | Self-report measure of pain-related functional interference. The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. Lower scores indicate less pain-related interference (i.e., better outcome). A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | baseline and 10 weeks post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale of Pain Intensity | self-report measure of pain intensity measured on a 0-10 likert scale. Participants are asked, "Please rate your pain by indicating the number that best describes your average pain over the past week on a 0 (no pain) to 10 (pain as bad as you can imagine) scale". Scores of 1-3 reflect mild pain, 4-6 moderate pain, and 7-10 severe pain. Lower scores reflect less pain, and therefore, better outcome. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana M. Higgins, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35192703 | Derived | Reuman L, Solar C, MacLean RR, Halat AM, Rajeevan H, Williams DA, Heapy AA, Bair MJ, Krein SL, Kerns RD, Higgins DM. If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program. Transl Behav Med. 2022 May 26;12(5):693-701. doi: 10.1093/tbm/ibab165. | |
| 31778281 |
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Participant enrollment began July 1, 2014 and last data collection for primary outcome was October 31, 2018. Recruitment target of 58 participants was met. 59 participants enrolled in the study (i.e., signed informed consent) but 58 completed baseline measures and were included in outcomes analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Week Pain EASE Access | behavioral pain self-management intervention (Pain EASE) delivered via the Internet behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
59 participants enrolled in the study (i.e., signed informed consent) but 58 completed baseline measures and were included in outcomes analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 Week Pain EASE Access | behavioral pain self-management intervention (Pain EASE) delivered via the Internet behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Multidimensional Pain Inventory Interference Subscale | Self-report measure of pain-related functional interference. The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. Lower scores indicate less pain-related interference (i.e., better outcome). A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | 17 of the 58 participants who completed baseline did not complete 10-week post-baseline assessment (study endpoint) | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and 10 weeks post-baseline |
|
10 weeks of active study participation
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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 | 10 Week Pain EASE Access | behavioral pain self-management intervention (Pain EASE) for chronic low back pain delivered via the Internet behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing Access to the Pain EASE intervention for 10 weeks: analyses were conducted to determine change from baseline on pain-related functional interference and other outcomes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric emergency room visit | Psychiatric disorders | Non-systematic Assessment | psychiatric emergency room visit for manic episode in the context of bipolar disorder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana M. Higgins, PhD | VA Boston Healthcare System | 857-364-2221 | diana.higgins2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2016 | Aug 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| baseline and 10 weeks post-baseline |
| Profile of Mood States | Total mood symptoms score reported. The 65-item Profile of Mood States (POMS) is a multidimensional measure of emotional functioning designed to assess six dimensions of mood "over the past week, including today". Each item is scored on a 0-5 Likert scale, where 0= "not at all" and 5= "extremely". Total Mood Disturbance score ranges from 0 to 200. Higher scores reflect poorer functioning. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | baseline and 10 weeks post-baseline |
| Multidimensional Fatigue Inventory | General fatigue scale reported. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI), which is a 20 item measure that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and how subscale statements regarding fatigue represent their experiences. Score range from 4 to 20. Higher total scores correspond with more acute levels of fatigue. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | baseline and 10 weeks post-baseline |
| Medical Outcomes Study Sleep Scale | The MOS Sleep Scale is a 12 item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems index 2). An additional single item assesses quantity of sleep. The sleep domains and problems index are scored on a 0 - 100 possible range, and higher scores indicate more of the concept being measured. Lower scores on sleep disturbance, for example, reflect less disturbed sleep, which is a better outcome. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | baseline and 10 weeks post-baseline |
| Beck Depression Inventory | Depressive symptom severity was assessed using the 21-item Beck Depression Inventory. Scores range from 0 - 63. Higher scores indicate more severe depression symptomatology. Lower scores correspond to better outcomes (i.e., less depressive symptom severity). Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | baseline and 10 weeks post-baseline |
| Higgins DM, Buta E, Williams DA, Halat A, Bair MJ, Heapy AA, Krein SL, Rajeevan H, Rosen MI, Kerns RD. Internet-Based Pain Self-Management for Veterans: Feasibility and Preliminary Efficacy of the Pain EASE Program. Pain Pract. 2020 Apr;20(4):357-370. doi: 10.1111/papr.12861. Epub 2020 Jan 28. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Count of Participants | Participants |
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| Multidimensional Pain Inventory Interference Subscale | The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning. | Mean | Standard Deviation | units on a scale |
|
| Pain Intensity Numeric Rating Scale | This is a likert scale self-report measures. Participants are asked, "Please rate your pain by indicating the number that best describes your average pain over the past week on a 0 (no pain) to 10 (pain as bad as you can imagine) scale". Scores of 1-3 reflect mild pain, 4-6 moderate pain, and 7-10 severe pain. | Mean | Standard Deviation | units on a scale |
|
| Profile of Mood States | Total mood symptoms score reported. The 65-item Profile of Mood States (POMS) is a multidimensional measure of emotional functioning designed to assess six dimensions of mood. Total Mood Disturbance score ranges from -32 to 200. Higher scores reflect poorer functioning. | Mean | Standard Deviation | units on a scale |
|
| Multidimensional Fatigue Inventory | Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI), which is a 20 item measure that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and how subscale statements regarding fatigue represent their experiences. Score range from 4 to 20. Higher total scores correspond with more acute levels of fatigue. | Mean | Standard Deviation | units on a scale |
|
| Medical Outcomes Study Sleep Scale | The MOS Sleep Scale is a 12 item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems index 2). An additional single item assesses quantity of sleep. The sleep domains and problems index are scored on a 0-100 possible range, and higher scores indicate more of the concept being measured. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory | Depressive symptom severity was assessed using the 21-item Beck Depression Inventory. Scores range from 0 - 63. Higher scores indicate more severe depression symptomatology. | Mean | Standard Deviation | units on a scale |
|
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
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| Secondary | Numeric Rating Scale of Pain Intensity | self-report measure of pain intensity measured on a 0-10 likert scale. Participants are asked, "Please rate your pain by indicating the number that best describes your average pain over the past week on a 0 (no pain) to 10 (pain as bad as you can imagine) scale". Scores of 1-3 reflect mild pain, 4-6 moderate pain, and 7-10 severe pain. Lower scores reflect less pain, and therefore, better outcome. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline and 10 weeks post-baseline |
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| Secondary | Profile of Mood States | Total mood symptoms score reported. The 65-item Profile of Mood States (POMS) is a multidimensional measure of emotional functioning designed to assess six dimensions of mood "over the past week, including today". Each item is scored on a 0-5 Likert scale, where 0= "not at all" and 5= "extremely". Total Mood Disturbance score ranges from 0 to 200. Higher scores reflect poorer functioning. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and 10 weeks post-baseline |
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| Secondary | Multidimensional Fatigue Inventory | General fatigue scale reported. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI), which is a 20 item measure that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and how subscale statements regarding fatigue represent their experiences. Score range from 4 to 20. Higher total scores correspond with more acute levels of fatigue. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and 10 weeks post-baseline |
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| Secondary | Medical Outcomes Study Sleep Scale | The MOS Sleep Scale is a 12 item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems index 2). An additional single item assesses quantity of sleep. The sleep domains and problems index are scored on a 0 - 100 possible range, and higher scores indicate more of the concept being measured. Lower scores on sleep disturbance, for example, reflect less disturbed sleep, which is a better outcome. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and 10 weeks post-baseline |
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| Secondary | Beck Depression Inventory | Depressive symptom severity was assessed using the 21-item Beck Depression Inventory. Scores range from 0 - 63. Higher scores indicate more severe depression symptomatology. Lower scores correspond to better outcomes (i.e., less depressive symptom severity). Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and 10 weeks post-baseline |
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| 0 |
| 58 |
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