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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33MH100250-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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To test the feasibility of a clinical trial implementing I-CAT, a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life) for 40 people with first episode psychosis in the context of a small randomized controlled trial.
Schizophrenia is one of the most devastating disorders that often results in a lack of functional recovery. Current treatments focused on remediating symptoms have shown only small successes in a return to functioning despite evidence of a dysregulated stress response. There is a fundamental gap in understanding the impact of allostatic overload in persons with schizophrenia that the investigators theorize is associated with deficits in functioning and with an increased vulnerability and relapse risk. The long-term goal is to test an intervention aimed at improving stress reactivity. The objective in this application is to develop and test the feasibility of a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping. The central hypothesis is that an intervention that improves stress reactivity as measured proximally by endocrine, immune, and autonomic indices will result in improved adaptive capacity, better role functioning, reduced risk of relapse, and decreased likelihood of disability for people in the early stages of schizophrenia.
The rationale for the proposed research is that stress reactivity may be a modifiable risk factor underlying functional deficits in schizophrenia. The intervention integrates two treatment approaches. The first is based on research showing that mindfulness meditation practice is associated with alterations in the neural processing of stressful events and targets adaptive responses to stress. The second focuses on providing a buffer against stress by using the self-generation of adaptive emotions with a positive psychology intervention, which is potentially associated with building protective social resources. These complimentary interventions provide a comprehensive synergistic approach for this population that could lead to more adaptive coping responses and create a buffer against stress
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-CAT | Experimental | A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. |
|
| Treatment as Usual | Active Comparator | Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) Outreach and Support Intervention Services (OASIS) Clinic by trained clinicians. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-CAT | Behavioral | I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life). |
| Measure | Description | Time Frame |
|---|---|---|
| Change Over Time on the mDES - Positive | The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the positive subscale indicate more positive emotions. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on the mDES - Negative | The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the negative subscale indicate more negative emotions. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on the QLS | The Quality of Life Scale (QLS) is a semi-structured 7-item interview with sub scales, including active acquaintances, social initiatives, occupational role functioning, degree of motivation, anhedonia, commonplace objects, and capacity for empathy. The 7-items are rated on a 7-point scale with higher ratings reflecting less impaired functioning (total range 7-49). Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on the FESFS | The First Episode Social Functioning Scale (FESFS) is a 42-item self-report measure assessing social functioning in early SSD. The FESFS includes a total score and eight subscales assessing: independent living skills, interacting with people in different contexts, social activities, intimacy, friendships, family relations, work, and school. Domain scores are averaged with higher scores reflecting better perceived functioning (range 0-4). Assessed at 4.5 months, 9 months, 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change Over Time on the PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) assessed current symptoms. PANSS items are rated on a seven-point scale with higher scores reflecting more severe symptoms (ICCs for study assessors >.90). Items are summed for a total score (range 30 - 210). Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Penn, PhD | The Unviersity of North Carolina at Chapel Hill | Principal Investigator |
| Diana Perkins, MD | The Unviersity of North Carolina at Chapel Hill | Principal Investigator |
| Piper S Meyer-Kalos, PhD | Minnesota Center for Chemical and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC OASIS Carrboro | Carrboro | North Carolina | 27510 | United States | ||
| UNC STEP |
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| ID | Title | Description |
|---|---|---|
| FG000 | I-CAT | A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life). |
| FG001 | Treatment as Usual | Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | I-CAT | A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change Over Time on the mDES - Positive | The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the positive subscale indicate more positive emotions. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
From baseline to study follow-up, a total of approximately 12 months.
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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 | I-CAT | A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased psychiatric symptoms | General disorders | Non-systematic Assessment | Hospitalization due to increased psychiatric symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Penn, PhD | University of North Carolina at Chapel Hill | (919) 843-7514 | dpenn@email.unc.edu |
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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 | Dec 10, 2020 | Dec 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as Usual | Behavioral | Treatment as usual defined by participant clinician at OASIS clinic. |
|
| Baseline, 4.5, 9, and 12 months |
| Change Over Time on the PSS | The Perceived Stress Scale (PSS) is a ten-item self-report measure of the degree to which daily situations from the past week are perceived as stressful, unpredictable, uncontrollable, as well as how "overloaded" individuals feel (0 = never, 4 = very often). Items are summed for a total score (range 0 - 40) with higher scores indicating more perceived stress. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on the DSI | The Daily Stress Inventory (DSI) is a 58-item self-report measure assessing the frequency and intensity of stressful events within the past 24-hours. If an event is endorsed, participants rate the amount of stress the event caused (0 = did not occur, 1 = occurred but was not stressful to 7 = occurred and caused me to panic). The DSI yields an average impact rating (AIR; average impact of ratings given items endorsed [sum/frequency]; range 1-7) with higher scores indicating more daily stress. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on Salivary Cortisol Levels | Salivary cortisol levels were collected as a measure of psychological stress. | Baseline, 9 months |
| Change Over Time on the FFMQ | The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report measure assessing facets of being mindful in daily life (i.e., observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience). Items are endorsed on a five-point scale (1 = never or rarely true to 5 = very often or always true) and averaged for a total score (range 1-5) with higher scores indicating greater mindfulness ability. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on the SCS | The Self-Compassion Scale Short Form (SCS) is a 12-item self-report measure of self-compassion. SCS items are endorsed on a five-point scale (1 = almost never to 5 = almost always) and are summed for a total score (range 12 - 60) with higher scores indicating higher levels of self-compassion. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Change Over Time on the PWB | The Psychological Well-Being Scale (PWB) is a 54-item self-report measure with items endorsed on a seven-point scale (1 = strongly disagree to 6 = strongly agree). Items are summed for a total score (range 54 - 324) with higher scores indicating better psychological well-being. Assessed at 4.5 months, 9 months, 12 months. | Baseline, 4.5, 9, and 12 months |
| Respiratory Sinus Arrhythmia | Index of heart rate variability assessed as the ratio of low-to-high frequencies in the respiratory-cardiac power spectrum. Mean level respiratory sinus arrhythmia (RSA) derived from heart rate monitor worn while participants engaged in a 5-minute mindfulness exercise. | 9 months |
| Carrboro |
| North Carolina |
| 27510 |
| United States |
| UNC Oasis Wake | Raleigh | North Carolina | 27603 | United States |
| UNC Wake STEP | Raleigh | North Carolina | 27610 | United States |
| BG001 | Treatment as Usual | Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| WASI-II Intelligence Quotient (IQ) Score | Wechsler Abbreviated Scale of Intelligence - 2nd Edition (WASI-II) is a standardized test of intelligence consisting of Matrix Reasoning, Vocabulary, Similarities, and the Block Design subtests with a total score that is converted to a standard t-score (possible range 40 - 160). A t-score of 50 is equal to the mean of the population with a standard deviation of 10. Scores less than 50 reflect scores less than the mean of the population whereas scores greater than 50 reflect scores more than the mean of the population. Higher scores indicate higher levels of intelligence. | Mean | Standard Deviation | t-score |
|
| Duration of Illness | Duration of Illness is defined as the years between study enrollment and initial schizophrenia spectrum disorder (SSD) diagnosis (range 0 - 9 for the current study). | Mean | Standard Deviation | years |
|
| PANSS Total | The Positive and Negative Syndrome Scale (PANSS) assessed current symptoms. PANSS items are rated on a seven-point scale with higher scores reflecting more severe symptoms (ICCs for study assessors >.90). Items are summed for a total score (range 30 - 210). | Mean | Standard Deviation | units on a scale |
|
| mDES - Positive Emotions | The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the positive subscale indicate more positive emotions. | Mean | Standard Deviation | units on a scale |
|
| mDES - Negative Emotions | The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the negative subscale indicate more negative emotions. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life Scale | The Quality of Life Scale (QLS) is a semi-structured 7-item interview with sub scales, including active acquaintances, social initiatives, occupational role functioning, degree of motivation, anhedonia, commonplace objects, and capacity for empathy. The 7-items are rated on a 7-point scale with higher ratings reflecting less impaired functioning (total range 7-49). | Mean | Standard Deviation | units on a scale |
|
| First Episode Social Functioning Scale | The First Episode Social Functioning Scale (FESFS) is a 42-item self-report measure assessing social functioning in early SSD. The FESFS includes a total score and eight subscales assessing: independent living skills, interacting with people in different contexts, social activities, intimacy, friendships, family relations, work, and school. Domain scores are averaged with higher scores reflecting better perceived functioning (range 0-4). | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale | The Perceived Stress Scale (PSS) is a ten-item self-report measure of the degree to which daily situations from the past week are perceived as stressful, unpredictable, uncontrollable, as well as how "overloaded" individuals feel (0 = never, 4 = very often). Items are summed for a total score (range 0 - 40) with higher scores indicating more perceived stress. | Mean | Standard Deviation | units on a scale |
|
| Daily Stress Inventory | The Daily Stress Inventory (DSI) is a 58-item self-report measure assessing the frequency and intensity of stressful events within the past 24-hours. If an event is endorsed, participants rate the amount of stress the event caused (0 = did not occur, 1 = occurred but was not stressful to 7 = occurred and caused me to panic). The DSI yields an average impact rating (AIR; average impact of ratings given items endorsed [sum/frequency]; range 1-7) with higher scores reflecting higher levels of stress experienced. | Mean | Standard Deviation | units on a scale |
|
| Five Facets of Mindfulness Questionnaire | The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report measure assessing facets of being mindful in daily life (i.e., observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience). Items are endorsed on a five-point scale (1 = never or rarely true to 5 = very often or always true) and averaged for a total score (range 1-5) with higher scores reflecting greater mindfulness abilities. | Mean | Standard Deviation | units on a scale |
|
| Self-Compassion Scale | The Self-Compassion Scale Short Form (SCS) is a 12-item self-report measure of self-compassion. SCS items are endorsed on a five-point scale (1 = almost never to 5 = almost always) and are summed for a total score (range 12 - 60) with higher scores indicating higher levels of self-compassion. | Mean | Standard Deviation | units on a scale |
|
| Perceived Well-Being Scale | The Psychological Well-Being Scale (PWB) is a 54-item self-report measure with items endorsed on a seven-point scale (1 = strongly disagree to 6 = strongly agree). Items are summed for a total score (range 54 - 324) with higher scores indicating better psychological well-being. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Treatment as Usual | Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic. |
|
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| Primary | Change Over Time on the mDES - Negative | The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the negative subscale indicate more negative emotions. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
|
|
| Primary | Change Over Time on the QLS | The Quality of Life Scale (QLS) is a semi-structured 7-item interview with sub scales, including active acquaintances, social initiatives, occupational role functioning, degree of motivation, anhedonia, commonplace objects, and capacity for empathy. The 7-items are rated on a 7-point scale with higher ratings reflecting less impaired functioning (total range 7-49). Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
|
|
| Primary | Change Over Time on the FESFS | The First Episode Social Functioning Scale (FESFS) is a 42-item self-report measure assessing social functioning in early SSD. The FESFS includes a total score and eight subscales assessing: independent living skills, interacting with people in different contexts, social activities, intimacy, friendships, family relations, work, and school. Domain scores are averaged with higher scores reflecting better perceived functioning (range 0-4). Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
|
|
| Primary | Change Over Time on the PSS | The Perceived Stress Scale (PSS) is a ten-item self-report measure of the degree to which daily situations from the past week are perceived as stressful, unpredictable, uncontrollable, as well as how "overloaded" individuals feel (0 = never, 4 = very often). Items are summed for a total score (range 0 - 40) with higher scores indicating more perceived stress. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
|
|
| Primary | Change Over Time on the DSI | The Daily Stress Inventory (DSI) is a 58-item self-report measure assessing the frequency and intensity of stressful events within the past 24-hours. If an event is endorsed, participants rate the amount of stress the event caused (0 = did not occur, 1 = occurred but was not stressful to 7 = occurred and caused me to panic). The DSI yields an average impact rating (AIR; average impact of ratings given items endorsed [sum/frequency]; range 1-7) with higher scores indicating more daily stress. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
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| Primary | Change Over Time on Salivary Cortisol Levels | Salivary cortisol levels were collected as a measure of psychological stress. | Saliva samples unable to be collected from all participants. | Posted | Least Squares Mean | Standard Error | ug/dL | Baseline, 9 months |
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| Secondary | Change Over Time on the PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) assessed current symptoms. PANSS items are rated on a seven-point scale with higher scores reflecting more severe symptoms (ICCs for study assessors >.90). Items are summed for a total score (range 30 - 210). Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
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| Secondary | Change Over Time on the FFMQ | The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report measure assessing facets of being mindful in daily life (i.e., observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience). Items are endorsed on a five-point scale (1 = never or rarely true to 5 = very often or always true) and averaged for a total score (range 1-5) with higher scores indicating greater mindfulness ability. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
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| Secondary | Change Over Time on the SCS | The Self-Compassion Scale Short Form (SCS) is a 12-item self-report measure of self-compassion. SCS items are endorsed on a five-point scale (1 = almost never to 5 = almost always) and are summed for a total score (range 12 - 60) with higher scores indicating higher levels of self-compassion. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
|
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| Secondary | Change Over Time on the PWB | The Psychological Well-Being Scale (PWB) is a 54-item self-report measure with items endorsed on a seven-point scale (1 = strongly disagree to 6 = strongly agree). Items are summed for a total score (range 54 - 324) with higher scores indicating better psychological well-being. Assessed at 4.5 months, 9 months, 12 months. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4.5, 9, and 12 months |
|
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| Secondary | Respiratory Sinus Arrhythmia | Index of heart rate variability assessed as the ratio of low-to-high frequencies in the respiratory-cardiac power spectrum. Mean level respiratory sinus arrhythmia (RSA) derived from heart rate monitor worn while participants engaged in a 5-minute mindfulness exercise. | Data not available for all participants due to device technical issues or post-treatment appointment completed remotely. | Posted | Least Squares Mean | Standard Error | ln(msec)^2 | 9 months |
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|
|
| 0 |
| 19 |
| 3 |
| 19 |
| 0 |
| 19 |
| EG001 | Treatment as Usual | Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic. | 0 | 19 | 2 | 19 | 0 | 19 |
|
| Discontinued medication | General disorders | Non-systematic Assessment | Participant discontinued psychiatric medication precipitating an increase in psychiatric symptoms, specifically suicidal ideation, which necessitated hospitalization |
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| Dyskinesia | General disorders | Non-systematic Assessment | Participant experienced dyskinesia precipitating hospitalization |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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| 12 months change from baseline |
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