Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01783080
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Depressive Disorder	Behavioral: Behavioral Activation for return to work	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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. 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: Behavioral Activation for return to work; See Arm Description

Outcome Measures

Primary Outcome Measures

1. Paid Work Hours at Week 12 [Week 12]

   Subject-reported paid work hours per week at week 12

2. Paid Work Hours at Week Baseline [Baseline]

   Subject-reported paid work hours per week at week baseline

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: David J Hellerstein, MD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01783080
• Other Study ID Numbers: #5908
• First Posted: Feb 4, 2013
• Last Update Posted: Jun 19, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by New York State Psychiatric Institute: Chronic depression; Dysthymic disorder; Double Depression; Behavioral Activation therapy; Work impairment; Unemployment
• Additional relevant MeSH terms: Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (12.3)
Sex: Female, Male (Count of Participants)
Female	7 43.8%
Male	9 56.3%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Paid Work Hours at Week 12
Description	Subject-reported paid work hours per week at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
Measure Participants	16
Mean (Standard Deviation) [hours]	30.3 (18.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Activation for Return to Work
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Paid Work Hours at Week Baseline
Description	Subject-reported paid work hours per week at week baseline
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
Measure Participants	16
Mean (Standard Deviation) [hours]	16.9 (16.2)

3. Secondary Outcome

Title	Social Functioning at Week Baseline on the Social Adjustment Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
Measure Participants	16
Mean (Standard Deviation) [unites on a scale]	2.4 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Activation for Return to Work
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Social Functioning at Week 12 on the Social Adjustment Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
Measure Participants	16
Mean (Standard Deviation) [unites on a scale]	2.18 (0.6)

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Behavioral Activation for Return to Work
Arm/Group Description	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
All Cause Mortality
	Behavioral Activation for Return to Work
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Behavioral Activation for Return to Work
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Activation for Return to Work
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.