DepressionBRIGHTNCT01191788
Building Recovery By Improving Goals, Habits, and Thoughts
A study testing Group Cognitive Behavioral Therapy and Group CBT for Depression in people with Depression and Substance Use, run by RAND at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Substance Use
- What is being tested?
- Group Cognitive Behavioral Therapy and Group CBT for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- present for treatment at one of four participating sites during study period
- score BDI>17 at 2-4 weeks post-treatment entry
Who cannot join
- cognitive impairment (score of 11 or greater on short Blessed exam)
- screen positive for bipolar or schizophrenia
- non-English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health Services, Inc
Gardena, California, 90249
About this study
Official title: Group Cognitive Behavioral Therapy (CBT) For Depression in Clients With Alcohol and Other Drug (AOD) Disorders
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.
Read the 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.
- Conditions
- Depression, Substance Use
- Being tested
- Group Cognitive Behavioral Therapy, Group CBT for Depression
- Keywords
- Depression, Substance Use, Group Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioral TherapyBehavioural
16 two hour sessions of group CBT
Group CBT for DepressionBehavioural
16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor
| Study group | Role | What they receive |
|---|---|---|
| Group CBT | Experimental | Clients received up to 16 sessions of group CBT for depression Receives: Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Group CBT for Depression |
| Comparison | Active comparator | Treatment as Usual comparison condition Receives: Behavioral: Group Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months Post Treatment
Secondary outcomes (1)
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.
Measured: 3 Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionMar 2010
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 (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Behavioral Health Services, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Katherine Watkins, MD, MSHS, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191788
- Sponsor's protocol ID
- R01AA014699-03
- Other IDs
- R01AA014699
- Acronym
- BRIGHT
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2010
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22638007Hunter 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.
PubMed 22564202Watkins 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.
PubMed 21646576
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Behavioral Therapy (CBT) For Depression in Clients With Alcohol and Other Drug (AOD) Disorders
- ClinicalTrials.gov ID
- NCT01191788
- Acronym / sponsor ID
- BRIGHT / R01AA014699-03
- Conditions
- Depression, Substance Use
- Keywords
- Depression, Substance Use, Group Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Behavioral Health Services, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 25 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CBT | Experimental | Behavioral: Group Cognitive Behavioral Therapy, Behavioral: Group CBT for DepressionClients received up to 16 sessions of group CBT for depression |
| Comparison | Active comparator | Behavioral: Group Cognitive Behavioral TherapyTreatment as Usual comparison condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- present for treatment at one of four participating sites during study period
- score BDI>17 at 2-4 weeks post-treatment entry
Key exclusion criteria (3 listed)
- cognitive impairment (score of 11 or greater on short Blessed exam)
- screen positive for bipolar or schizophrenia
- non-English speaker
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 |
|---|---|---|
| Group Cognitive Behavioral Therapy16 two hour sessions of group CBT | Behavioural | Comparison, Group CBT |
| Group CBT for Depression16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor | Behavioural | Group CBT |
Primary outcome
Depressive Symptoms as Measured by the Beck Depression Inventory II
Time frame: 3 Months Post Treatment
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.
1 secondary outcome
Mental Health Functioning as Measured by SF-12 MCS.
Time frame: 3 Months Post Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22638007Watkins 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.
- Derived from this study: PubMed 22564202Hunter 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.
- Derived from this study: PubMed 21646576Watkins 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.
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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.
Katherine Watkins, MD, MSHS principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behavioral Therapy and Group CBT for Depression in people with Depression and Substance Use, run by RAND 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 2 inclusion and 3 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 18 Oct 2022. 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 25 Jun 2012). 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?
Depressive Symptoms as Measured by the Beck Depression Inventory II (time frame: 3 Months Post Treatment). 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 NCT01191788, which also lists 3 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 18 Oct 2022.