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The investigators aimed to assess the ability of a modified version of Behavioral Activation for occupational and social improvement to produce change in: 1. social adjustment, 2. work functioning, 3. avoidance behavior and 4. behavioral activation.
Psychosocial functioning was assessed before and after BA treatment in medication responsive depressed individuals who continued to have impaired social functioning. The primary goal was to demonstrate feasibility of recruitment and retention, and obtain an open pilot sense as to whether there are benefits from this brief psychotherapy approach in this population. The investigators also planned to refine measures and estimate the effect size of any treatment response to estimate power and sample size with the goal of completing a future controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation for Return to Work | Experimental | BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation for return to work | Behavioral | See Arm Description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Paid Work Hours at Week 12 | Subject-reported paid work hours per week at week 12 | Week 12 |
| Paid Work Hours at Week Baseline | Subject-reported paid work hours per week at week baseline | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Social Functioning at Week Baseline on the Social Adjustment Scale | Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Hellerstein, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21586994 | Background | Erickson G, Hellerstein DJ. Behavioral activation therapy for remediating persistent social deficits in medication-responsive chronic depression. J Psychiatr Pract. 2011 May;17(3):161-9. doi: 10.1097/01.pra.0000398409.21374.ab. | |
| 25464836 | Result | Hellerstein DJ, Erickson G, Stewart JW, McGrath PJ, Hunnicutt-Ferguson K, Reynolds SK, O'Shea D, Chen Y, Withers A, Wang Y. Behavioral activation therapy for return to work in medication-responsive chronic depression with persistent psychosocial dysfunction. Compr Psychiatry. 2015 Feb;57:140-7. doi: 10.1016/j.comppsych.2014.10.015. Epub 2014 Nov 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation for Return to Work | BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers. Behavioral Activation for return to work: See Arm Description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Activation for Return to Work | BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers. Behavioral Activation for return to work: See Arm Description |
| 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 | Paid Work Hours at Week 12 | Subject-reported paid work hours per week at week 12 | Posted | Mean | Standard Deviation | hours | Week 12 |
|
16 weeks
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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 | Behavioral Activation for Return to Work | BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers. Behavioral Activation for return to work: See Arm Description |
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This was a small open treatment study, without a comparator group and with limited followup. Findings of this pilot study should be replicated in a larger prospective trial with a randomized design, and with longer followup.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J Hellerstein MD, Professor of Clinical Psychiatry, Columbia | NY State Psychiatric Institute | 646-774-8000 | hellers@nypsi.columbia.edu |
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| ID | Term |
|---|---|
| D019263 | Dysthymic Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062707 | Return to Work |
| ID | Term |
|---|---|
| D004651 | Employment |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| baseline |
| Social Functioning at Week 12 on the Social Adjustment Scale | Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning | Week 12 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Paid Work Hours at Week Baseline | Subject-reported paid work hours per week at week baseline | Posted | Mean | Standard Deviation | hours | Baseline |
|
|
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| Secondary | Social Functioning at Week Baseline on the Social Adjustment Scale | Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning | Posted | Mean | Standard Deviation | unites on a scale | baseline |
|
|
|
|
| Secondary | Social Functioning at Week 12 on the Social Adjustment Scale | Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning | Posted | Mean | Standard Deviation | unites on a scale | Week 12 |
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| 0 |
| 16 |
| 0 |
| 16 |
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