Depressive Symptoms, Posttraumatic Stress Disorders, Substance-related Disorders
Conditions
Keywords
Depressive symptoms, Substance-related disorders, Posttraumatic stress disorders, Psychotherapy
Brief summary
This study will compare two different types of psychotherapy for Veterans with depression, addiction, and a past traumatic experience. Everyone in the study will receive 12 weeks of group cognitive behavioral therapy focused on depression and addiction, followed by 12 weeks of individual psychotherapy sessions. For the second 12 weeks, half of the people will receive a review of the initial therapy, and half will receive a cognitive behavioral therapy focused on trauma. Everyone will complete research interviews every 3 months for a total of 18 months.
Detailed description
The goal of this study is to evaluate whether a second disorder-specific intervention improves longer term (up to 18 months) treatment outcomes for male and female Veterans with co-occurring depression and alcohol/substance disorders and trauma history (with or without PTSD diagnosis). This 4 years randomized two-group design uses repeated assessments at baseline and every 3 months for a total of 12 months. The investigators are providing their recently developed integrated intervention for comorbid depression and substance disorders for the initial 12 weeks in group format (Integrated Cognitive Behavioral Therapy; Phase I). After the 12 week group intervention, participants will be randomized to receive either a review of the initial intervention in individual sessions, or a trauma-specific intervention, Cognitive Processing Therapy, with integrated addiction treatment components. Length, duration, and setting of both interventions will be the same, and all participants will meet with the program psychiatrist for medication appointments. No medications are under study and no placebo is used; medications will be prescribed using standard VA protocol. Research assessments will document diagnosis, recent substance use, depression and PTSD symptoms, medication adherence, and life stress.
Interventions
BEHAVIORALCognitive Processing Therapy-Modified (CPT-M)
Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills, reduce depression and substance relapse. CPT-M was delivered in individual 1-hour sessions once weekly.
BEHAVIORALIntegrated Cognitive Behavioral Therapy (ICBT)
Psychotherapy that focuses on thoughts and behaviors associated with depression with the goal of developing skills to reduce depression symptoms. We have integrated substance relapse prevention skills. ICBT was delivered in individual 1-hour sessions once weekly.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans 18 years of age and older living in the San Diego, California area * Who are able to attend in-person therapy sessions * Have depression, alcohol or substance addiction, and a past traumatic experience
Exclusion criteria
* Non-veterans * Individuals with schizophrenia or severe memory impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale. | Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) | Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis. |
| Posttraumatic Stress Disorder (PTSD) Symptoms | Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) | The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis. |
| Timeline Followback | Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months) | The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (\>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization. |
Countries
United States
Participant flow
Recruitment details
Veterans referred to a VA dual diagnosis outpatient clinic who were diagnosed with depressive disorder, substance use disorder, and had a history of trauma (with and without a posttraumatic stress disorder diagnosis) were recruited from December 2009 through October 2012.
Pre-assignment details
All participants engaged in 12 weeks of group Integrated Cognitive Behavioral Therapy and were then randomized to the individual study interventions. 31 participants were not randomized (3 died, 6 moved, 6 withdrew, 4 lost, 4 not stable, 4 did not meet study criteria, 4 sober living facility did not allow).
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: CPT-M Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills. | 61 |
| Arm 2: ICBT Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse | 62 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Inpatient hospitalization | 0 | 1 |
| Overall Study | Lost to Follow-up | 17 | 19 |
| Overall Study | Moved out of area | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Arm 1: CPT-M | Arm 2: ICBT | Total |
|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 12.1 | 47.3 years STANDARD_DEVIATION 11.9 | 47.3 years STANDARD_DEVIATION 12 |
| PTSD Current diagnosis without PTSD diagnosis | 10 participants | 12 participants | 22 participants |
| PTSD Current diagnosis with PTSD diagnosis | 51 participants | 50 participants | 101 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 55 Participants | 54 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 61 | 55 / 62 | 1 / 20 |
| serious Total, serious adverse events | 15 / 61 | 19 / 62 | 10 / 23 |
Outcome results
Primary
Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.
Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.
Time frame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Cognitive Processing Therapy- Modified | Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale. | 31.92 units on a scale | Standard Deviation 12.37 |
| Arm 2: Integrated Cognitive Behavioral Therapy | Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale. | 28.85 units on a scale | Standard Deviation 12.25 |
Comparison: Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.p-value: <0.05Linear Mixed Effects Models
Primary
Posttraumatic Stress Disorder (PTSD) Symptoms
The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.
Time frame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Cognitive Processing Therapy- Modified | Posttraumatic Stress Disorder (PTSD) Symptoms | 58.4 units on a scale | Standard Deviation 12.4 |
| Arm 2: Integrated Cognitive Behavioral Therapy | Posttraumatic Stress Disorder (PTSD) Symptoms | 55.5 units on a scale | Standard Deviation 14.2 |
p-value: <0.05Linear Mixed Effects Models
Primary
Timeline Followback
The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (\>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.
Time frame: Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Cognitive Processing Therapy- Modified | Timeline Followback | .84 proportion of days abstinent | Standard Deviation 0.26 |
| Arm 2: Integrated Cognitive Behavioral Therapy | Timeline Followback | .81 proportion of days abstinent | Standard Deviation 0.3 |
Comparison: Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.p-value: <0.05Linear Mixed Effects Model
Comparison: Second statistical analysis evaluates trajectories of heavy drinking (\<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.p-value: <0.05Linear Mixed Effects Model