An interventional study of Cognitive Processing Therapy-Modified (CPT-M) and Integrated Cognitive Behavioral Therapy (ICBT) in Depressive Symptoms, Substance-related Disorders and Posttraumatic Stress Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
12 individually delivered sessions of Cognitive Processing Therapy-Modified (CPT-M) provided once weekly following initial group delivery of 12 sessions of Integrated Cognitive Behavioral Therapy
Behavioral: Cognitive Processing Therapy-Modified (CPT-M)
12 individually delivered sessions of Integrated Cognitive Behavioral Therapy (ICBT) once weekly following initial group delivery of 12 sessions of ICBT
Behavioral: Integrated Cognitive Behavioral Therapy (ICBT)
All participants were enrolled in an initial group-delivered Integrated Cognitive Therapy Group, consisting of 12 sessions over approximately 12 weeks prior to randomization to one of the study individually delivered interventions (CPT-M or ICBT). Individuals who were no longer participating in the study at the end of group sessions were not randomized.
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.
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.
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)
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)
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)
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.
| Milestone | Arm 1: Cognitive Processing Therapy- Modified | Arm 2: Integrated Cognitive Behavioral Therapy |
|---|---|---|
| Started | 61 | 62 |
| End of treatment | 56 | 57 |
| Completed | 37 | 37 |
| Not completed | 24 | 25 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Lost to follow-up | 17 | 19 |
| Withdrew: Moved out of area | 1 | 1 |
| Withdrew: Inpatient hospitalization | 0 | 1 |
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.
| units on a scale | Arm 1: Cognitive Processing Therapy- Modified | Arm 2: Integrated Cognitive Behavioral Therapy |
|---|---|---|
| Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale. | 31.92 ± 12.37 | 28.85 ± 12.25 |
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.
| units on a scale | Arm 1: Cognitive Processing Therapy- Modified | Arm 2: Integrated Cognitive Behavioral Therapy |
|---|---|---|
| Posttraumatic Stress Disorder (PTSD) Symptoms | 58.4 ± 12.4 | 55.5 ± 14.2 |
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.
| proportion of days abstinent | Arm 1: Cognitive Processing Therapy- Modified | Arm 2: Integrated Cognitive Behavioral Therapy |
|---|---|---|
| Timeline Followback | .84 ± .26 | .81 ± .30 |
Collected over 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Cognitive Processing Therapy- Modified | — | 15/61 (24.6%) | 25/61 (41%) |
| Arm 2: Integrated Cognitive Behavioral Therapy | — | 19/62 (30.6%) | 55/62 (88.7%) |
| ICBT Prior to Randomization | — | 10/23 (43.5%) | 1/20 (5%) |
| Event | Arm 1: Cognitive Processing Therapy- Modified | Arm 2: Integrated Cognitive Behavioral Therapy | ICBT Prior to Randomization |
|---|---|---|---|
| Inpatient psychiatric admission for suicidal ideation/behaviorsPsychiatric disorders | 6/61 | 10/62 | 3/23 |
| Death - unknown causeGeneral disorders | 1/61 | 0/62 | 3/23 |
| Inpatient admission for alcohol/drug treatmentPsychiatric disorders | 4/61 | 1/62 | 1/23 |
| Medical inpatient admission - infectionInfections and infestations | 1/61 | 3/62 | 0/23 |
| Medical inpatient admission - alcohol relatedGastrointestinal disorders | 1/61 | 2/62 | 1/23 |
| Medical inpatient admission - surgeryGastrointestinal disorders | 0/61 | 0/62 | 1/23 |
| Emergency Dept visit - intoxicationPsychiatric disorders | 0/61 | 0/62 | 1/23 |
| Death - liver diseaseHepatobiliary disorders | 1/61 | 0/62 | 0/23 |
| Medical inpatient admission - assault injuriesInjury, poisoning and procedural complications | 1/61 | 0/62 | 0/23 |
| Death - hit by motor vehicleInjury, poisoning and procedural complications | 0/61 | 1/62 | 0/23 |
| Event | Arm 1: Cognitive Processing Therapy- Modified | Arm 2: Integrated Cognitive Behavioral Therapy | ICBT Prior to Randomization |
|---|---|---|---|
| Urgent Care, MedicalGeneral disorders | 15/61 | 32/62 | 0/20 |
| Arrest/jail/legalPsychiatric disorders | 6/61 | 10/62 | 1/20 |
| Outpatient surgeryGeneral disorders | 1/61 | 10/62 | 0/20 |
| Urgent Care, PsychiatricPsychiatric disorders | 3/61 | 3/62 | 0/20 |
| Age, Continuous(years) | Arm 1: CPT-M | Arm 2: ICBT | Total |
|---|---|---|---|
| Mean | 47.2 ± 12.1 | 47.3 ± 11.9 | 47.3 ± 12.0 |
| Sex: Female, Male(Participants) | Arm 1: CPT-M | Arm 2: ICBT | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 55 | 54 | 109 |
| PTSD Current diagnosis(participants) | Arm 1: CPT-M | Arm 2: ICBT | Total |
|---|---|---|---|
| with PTSD diagnosis | 51 | 50 | 101 |
| without PTSD diagnosis | 10 | 12 | 22 |
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