Persistent Depressive DisorderNCT01783080

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

A study testing Behavioral Activation for return to work in people with Persistent Depressive Disorder, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Persistent Depressive Disorder
What is being tested?: Behavioral Activation for return to work
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Read the 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.

Conditions: Persistent Depressive Disorder
Being tested: Behavioral Activation for return to work
Keywords: Chronic depression, Dysthymic disorder, Double Depression, Behavioral Activation therapy, Work impairment, Unemployment
Medical subject headings: Dysthymic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral Activation for return to workBehavioural
See Arm Description

Study groups in NCT01783080
Study group	Role	What they receive
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. Receives: Behavioral: Behavioral Activation for return to work

What is being measured

The primary outcome is the main question the study is designed to answer.

Paid Work Hours at Week 12
Subject-reported paid work hours per week at week 12
Measured: Week 12
Paid Work Hours at Week Baseline
Subject-reported paid work hours per week at week baseline
Measured: Baseline

Secondary outcomes (2)

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
Measured: 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
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Dec 2012

First posted4 Feb 2013 (estimated)
Study startJun 2010
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Persistent Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01783080
Sponsor's protocol ID: #5908
Status last verified: Apr 2017
First submitted: 25 Jan 2013
Last updated: 19 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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.
PubMed 21586994
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.
PubMed 25464836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Persistent Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
ClinicalTrials.gov ID: NCT01783080
Acronym / sponsor ID: #5908
Conditions: Persistent Depressive Disorder
Keywords: Chronic depression, Dysthymic disorder, Double Depression, Behavioral Activation therapy, Work impairment, Unemployment
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: Jun 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 4 Feb 2013 (estimated)
Results: Posted 19 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Behavioral Activation for Return to Work	Experimental	Behavioral: Behavioral Activation for return to workBA 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral Activation for return to workSee Arm Description	Behavioural	Behavioral Activation for Return to Work

Primary outcome

Paid Work Hours at Week 12
Time frame: Week 12
Subject-reported paid work hours per week at week 12
Paid Work Hours at Week Baseline
Time frame: Baseline
Subject-reported paid work hours per week at week baseline

2 secondary outcomes

Social Functioning at Week Baseline on the Social Adjustment Scale
Time frame: baseline
Social Functioning at Week 12 on the Social Adjustment Scale
Time frame: Week 12

Results and safety

Results posted to the registry on 19 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Behavioral Activation for Return to Work	16	16

Primary outcome: Paid Work Hours at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: hours

Measure	Behavioral Activation for Return to Work n = 16
Value	30.3 (18.8)

Behavioral Activation for Return to Work: Mean Difference (Final Values): 13.4, p = 0.005, Regression, Linear

Primary outcome: Paid Work Hours at Week Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: hours

Measure	Behavioral Activation for Return to Work n = 16
Value	16.9 (16.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Behavioral Activation for Return to Work	0 of 16 (0%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21586994Erickson 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.
Results publication: PubMed 25464836Hellerstein 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David J Hellerstein, MD principal investigator

New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation for return to work in people with Persistent Depressive Disorder, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paid Work Hours at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01783080, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.