NCT01191788

Brief Summary

The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care. 360 clients with Beck Depression Inventory-II scores \> 17 who are being treated in a single public sector AOD treatment organization will receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators will collect data on the service-level costs and health effects associated with UC and CBT, and will calculate the incremental cost per unit of depression and AOD improvement, compared to UC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 25, 2012

Completed
Last Updated

October 18, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

June 29, 2010

Results QC Date

October 24, 2011

Last Update Submit

September 21, 2022

Conditions

DepressionSubstance Use

Keywords

DepressionSubstance UseGroup Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms as Measured by the Beck Depression Inventory II

    The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.

    3 Months Post Treatment

Secondary Outcomes (1)

  • Mental Health Functioning as Measured by SF-12 MCS.

    3 Months Post Treatment

Study Arms (2)

Group CBT

EXPERIMENTAL

Clients received up to 16 sessions of group CBT for depression

Behavioral: Group Cognitive Behavioral TherapyBehavioral: Group CBT for Depression

Comparison

ACTIVE COMPARATOR

Treatment as Usual comparison condition

Behavioral: Group Cognitive Behavioral Therapy

Interventions

Group Cognitive Behavioral TherapyBEHAVIORAL

16 two hour sessions of group CBT

ComparisonGroup CBT
Group CBT for DepressionBEHAVIORAL

16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor

Group CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • present for treatment at one of four participating sites during study period
  • score BDI\>17 at 2-4 weeks post-treatment entry

You may not qualify if:

  • cognitive impairment (score of 11 or greater on short Blessed exam)
  • screen positive for bipolar or schizophrenia
  • non-English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Health Services, Inc

Gardena, California, 90249, United States

Location

Related Publications (3)

  • Watkins KE, Hunter S, Hepner K, Paddock S, Zhou A, de la Cruz E. Group cognitive-behavioral therapy for clients with major depression in residential substance abuse treatment. Psychiatr Serv. 2012 Jun;63(6):608-11. doi: 10.1176/appi.ps.201100201.

    PMID: 22638007DERIVED

  • Hunter SB, Witkiewitz K, Watkins KE, Paddock SM, Hepner KA. The moderating effects of group cognitive-behavioral therapy for depression among substance users. Psychol Addict Behav. 2012 Dec;26(4):906-16. doi: 10.1037/a0028158. Epub 2012 May 7.

    PMID: 22564202DERIVED

  • Watkins KE, Hunter SB, Hepner KA, Paddock SM, de la Cruz E, Zhou AJ, Gilmore J. An effectiveness trial of group cognitive behavioral therapy for patients with persistent depressive symptoms in substance abuse treatment. Arch Gen Psychiatry. 2011 Jun;68(6):577-84. doi: 10.1001/archgenpsychiatry.2011.53.

    PMID: 21646576DERIVED

MeSH Terms

Conditions

DepressionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Katherine Watkins
Organization
RAND Corporation
kwatkins@rand.org
(310) 393-0411

Study Officials

  • Katherine Watkins, MD, MSHS

    RAND

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2010

First Posted

August 31, 2010

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

March 1, 2010

Last Updated

October 18, 2022

Results First Posted

June 25, 2012

Record last verified: 2022-09

Locations

US(1)