search
Back to results

Building Recovery By Improving Goals, Habits, and Thoughts (BRIGHT)

Primary Purpose

Depression, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Cognitive Behavioral Therapy
Group CBT for Depression
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Depression, Substance Use, Group Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Behavioral Health Services, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group CBT

Comparison

Arm Description

Clients received up to 16 sessions of group CBT for depression

Treatment as Usual comparison condition

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mental Health Functioning as Measured by SF-12 MCS.
The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.

Full Information

First Posted
June 29, 2010
Last Updated
September 21, 2022
Sponsor
RAND
Collaborators
Behavioral Health Services, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01191788
Brief Title
Building Recovery By Improving Goals, Habits, and Thoughts
Acronym
BRIGHT
Official Title
Group Cognitive Behavioral Therapy (CBT) For Depression in Clients With Alcohol and Other Drug (AOD) Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Behavioral Health Services, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Individuals with alcohol and other drug (AOD) disorders frequently suffer from depression, leading to reduced quality of life and poorer AOD treatment outcomes. Efficacious treatments for depression do exist and could improve outcomes; but national data suggest that fewer than 7% of people with co-occurring disorders who are in AOD treatment have received appropriate treatment. Group cognitive behavioral therapy (CBT) is an effective and inexpensive treatment for depression. We propose to investigate whether group CBT for depression, with AOD counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care. We propose a 5-year quasi-experimental study with the following specific aims: Aim 1. To evaluate the effectiveness of group CBT for depression provided by AOD counselors in improving depressive symptoms and AOD outcomes, among clients being treated in public sector residential AOD treatment settings; Aim 2. To evaluate the cost-effectiveness of group CBT conducted by trained AOD counselors compared to usual care AOD treatment; Aim 3. To document the implementation of the intervention at each of the four sites, and to determine whether the AOD counselors are delivering the group CBT intervention with fidelity to the model, and whether treatment fidelity is a significant predictor of client outcomes. We will enroll and follow 360 clients with Beck Depression Inventory-II (BDI-II) scores > 17 who are being treated in a single public sector AOD treatment organization at four residential sites in LA County. Subjects 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). Subjects will complete: (1) a baseline interview; (2) a post-treatment interview (at the conclusion of the CBT treatment) and (3) a follow-up interview (3 months after CBT treatment ends). Data will be analyzed using an intent-to-treat model. We 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. . The implementation analysis will involve two related sets of activities: (1) a series of key informant interviews to provide a context in which to understand intervention implementation and (2) an assessment of treatment fidelity and it's relationship to client outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance Use
Keywords
Depression, Substance Use, Group Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group CBT
Arm Type
Experimental
Arm Description
Clients received up to 16 sessions of group CBT for depression
Arm Title
Comparison
Arm Type
Active Comparator
Arm Description
Treatment as Usual comparison condition
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavioral Therapy
Intervention Description
16 two hour sessions of group CBT
Intervention Type
Behavioral
Intervention Name(s)
Group CBT for Depression
Intervention Description
16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor
Primary Outcome Measure Information:
Title
Depressive Symptoms as Measured by the Beck Depression Inventory II
Description
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.
Time Frame
3 Months Post Treatment
Secondary Outcome Measure Information:
Title
Mental Health Functioning as Measured by SF-12 MCS.
Description
The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.
Time Frame
3 Months Post Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: present for treatment at one of four participating sites during study period score BDI>17 at 2-4 weeks post-treatment entry Exclusion Criteria: cognitive impairment (score of 11 or greater on short Blessed exam) screen positive for bipolar or schizophrenia non-English speaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Watkins, MD, MSHS
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Health Services, Inc
City
Gardena
State/Province
California
ZIP/Postal Code
90249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22638007
Citation
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.
Results Reference
derived
PubMed Identifier
22564202
Citation
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.
Results Reference
derived
PubMed Identifier
21646576
Citation
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.
Results Reference
derived

Learn more about this trial

Building Recovery By Improving Goals, Habits, and Thoughts

We'll reach out to this number within 24 hrs