Persistent Depressive Disorder
Conditions
Keywords
Chronic depression, Dysthymic disorder, Double Depression, Behavioral Activation therapy, Work impairment, Unemployment
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Activation for return to work
See Arm Description
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adults aged 20-75 years * a primary diagnosis of Dysthymic Disorder, Chronic major depressive disorder or double depression * a \>50% decrease in 17 item Hamilton Rating Scale for Depression (HRSD-17) score and a final HRSD-17 score ≤ 10 with an adequate antidepressant medication (ADM) trial (\> 4 weeks on at least 50% Physician's Desk Reference maximum ADM dose) * a rating of 1 (very much improved) or 2 (much improved) on the Clinical Global Impressions-Improvement scale (CGI-I) * continued functional impairment, defined by scores \>1.9 on the Social Adjustment Scale (SAS) * unemployment (jobless, looking for work) according to the Bureau of Labor Statistics: jobless and looking and available for work, or underemployed.
Exclusion criteria
* Structured Clinical Interview for Diagnostic and Statistical Manual, fourth edition (DSM-IV) Axis I disorders-diagnosed cognitive or psychotic disorders * bipolar disorder * active eating disorders * severe borderline personality disorder * alcohol or drug dependence (except nicotine) in the last 6 months * current suicide risk * unstable medical conditions * use of psychotropic medications other than antidepressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paid Work Hours at Week 12 | Week 12 | Subject-reported paid work hours per week at week 12 |
| Paid Work Hours at Week Baseline | Baseline | Subject-reported paid work hours per week at week baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Functioning at Week Baseline on the Social Adjustment Scale | baseline | 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 |
| Social Functioning at Week 12 on the Social Adjustment Scale | Week 12 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Behavioral Activation for Return to Work |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Paid Work Hours at Week 12
Subject-reported paid work hours per week at week 12
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation for Return to Work | Paid Work Hours at Week 12 | 30.3 hours | Standard Deviation 18.8 |
p-value: 0.005Regression, Linear
Primary
Paid Work Hours at Week Baseline
Subject-reported paid work hours per week at week baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation for Return to Work | Paid Work Hours at Week Baseline | 16.9 hours | Standard Deviation 16.2 |
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation for Return to Work | Social Functioning at Week 12 on the Social Adjustment Scale | 2.18 unites on a scale | Standard Deviation 0.6 |
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
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation for Return to Work | Social Functioning at Week Baseline on the Social Adjustment Scale | 2.4 unites on a scale | Standard Deviation 0.5 |
p-value: 0.11Regression, Linear