Depression, Substance Use
Conditions
Keywords
Depression, Substance Use, Group Cognitive Behavioral Therapy
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.
Interventions
BEHAVIORALGroup Cognitive Behavioral Therapy
16 two hour sessions of group CBT
BEHAVIORALGroup CBT for Depression
16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor
Sponsors
Behavioral Health Services, Inc.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
RAND
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms as Measured by the Beck Depression Inventory II | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mental Health Functioning as Measured by SF-12 MCS. | 3 Months Post Treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group CBT Clients received up to 16 sessions of group CBT for depression | 140 |
| Comparison Treatment as Usual comparison condition | 159 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 22 |
Baseline characteristics
| Characteristic | Total | Group CBT | Comparison |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 298 Participants | 139 Participants | 159 Participants |
| Age, Continuous | 36.23 years STANDARD_DEVIATION 10.34 | 35.31 years STANDARD_DEVIATION 10.08 | 37.04 years STANDARD_DEVIATION 10.53 |
| Region of Enrollment United States | 299 participants | 140 participants | 159 participants |
| Sex: Female, Male Female | 144 Participants | 70 Participants | 74 Participants |
| Sex: Female, Male Male | 155 Participants | 70 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 140 | 0 / 159 |
| serious Total, serious adverse events | 0 / 140 | 0 / 159 |
Outcome results
Primary
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.
Time frame: 3 Months Post Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group CBT | Depressive Symptoms as Measured by the Beck Depression Inventory II | 14.83 BDI-II score | Standard Deviation 11.23 |
| Comparison | Depressive Symptoms as Measured by the Beck Depression Inventory II | 21.82 BDI-II score | Standard Deviation 12.74 |
Secondary
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.
Time frame: 3 Months Post Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group CBT | Mental Health Functioning as Measured by SF-12 MCS. | 44.71 SF-12 score | Standard Deviation 11.34 |
| Comparison | Mental Health Functioning as Measured by SF-12 MCS. | 38.44 SF-12 score | Standard Deviation 11.89 |