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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy-Modified | Experimental | 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 |
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| Integrated Cognitive Behavioral Therapy | Active Comparator | 12 individually delivered sessions of Integrated Cognitive Behavioral Therapy (ICBT) once weekly following initial group delivery of 12 sessions of ICBT |
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| Integrated Cognitive Behavioral Group Therapy | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy-Modified (CPT-M) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) |
| Timeline Followback |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Tate, PhD | VA San Diego Healthcare System, San Diego/University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28632462 | Derived | Siegel EY, Haller M, Cui R, Trim RS, Tate SR, Norman SB. Examining changes in negative mood regulation expectancies, posttraumatic stress disorder, depression, and substance use following integrated cognitive-behavioral therapy. Subst Abus. 2017 Oct-Dec;38(4):468-472. doi: 10.1080/08897077.2017.1342736. Epub 2017 Jun 20. | |
| 26828770 |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Cognitive Processing Therapy- Modified | Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Integrated Cognitive Behavioral Therapy (ICBT) | Behavioral | 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. |
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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. |
| Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months) |
| Cui R, Haller M, Skidmore JR, Goldsteinholm K, Norman S, Tate SR. Treatment Attendance Among Veterans With Depression, Substance Use Disorder, and Trauma. J Dual Diagn. 2016;12(1):15-26. doi: 10.1080/15504263.2016.1146384. |
| FG001 | Arm 2: Integrated Cognitive Behavioral Therapy | Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. 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 |
| End of Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| PTSD Current diagnosis | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) |
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| 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. | Posted | Mean | Standard Deviation | proportion of days abstinent | Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months) |
|
4 years
Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Cognitive Processing Therapy- Modified | Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. 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. | 15 | 61 | 25 | 61 | ||
| EG001 | Arm 2: Integrated Cognitive Behavioral Therapy | Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. 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 | 19 | 62 | 55 | 62 | ||
| EG002 | ICBT Prior to Randomization | All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills. This portion will report on only those participants who were not randomized to individual CPT-M or ICBT. | 10 | 23 | 1 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient psychiatric admission for suicidal ideation/behaviors | Psychiatric disorders | Systematic Assessment |
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| Inpatient admission for alcohol/drug treatment | Psychiatric disorders | Systematic Assessment |
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| Death - unknown cause | General disorders | Non-systematic Assessment |
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| Death - liver disease | Hepatobiliary disorders | Systematic Assessment |
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| Death - hit by motor vehicle | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Suicidal behavior under the influence | Psychiatric disorders | Systematic Assessment |
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| Medical inpatient admission - alcohol related | Gastrointestinal disorders | Systematic Assessment |
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| Medical inpatient admission - infection | Infections and infestations | Systematic Assessment |
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| Medical inpatient admission - surgery | Gastrointestinal disorders | Systematic Assessment |
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| Medical inpatient admission - assault injuries | Injury, poisoning and procedural complications | Systematic Assessment |
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| Disappearance | Psychiatric disorders | Systematic Assessment | Left sober living facility and left all belongings without notice and no information |
| |
| Emergency Dept visit - intoxication | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrest/jail/legal | Psychiatric disorders | Systematic Assessment | Arrests, brief incarceration, or court appearances related to alcohol/drug use |
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| Outpatient surgery | General disorders | Systematic Assessment | Outpatient surgeries for variety of medical issues |
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| Urgent Care, Medical | General disorders | Systematic Assessment | Emergency Department or Urgent Care treatment for variety of medical issues |
| |
| Urgent Care, Psychiatric | Psychiatric disorders | Systematic Assessment | Emergency Department or Urgent Care treatment for psychiatric and substance-related issues |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan R. Tate, Ph.D., Clinical Psychologist | VA San Diego Healthcare System/UCSD | 619-426-9402 | srtate@ucsd.edu |
| ID | Term |
|---|---|
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| Male |
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| without PTSD diagnosis |
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| OG001 | Arm 2: Integrated Cognitive Behavioral Therapy | Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. 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 |
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Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
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
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