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The investigators are examining different treatment strategies of helping patients with PTSD and addiction.
The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and 9 month follow-ups. The investigators further hypothesize that offering Veterans Prolonged Exposure (PE) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Integrated Conditions | Experimental | Motivational enhancement therapy for addiction is combined with Prolonged exposure therapy for PTSD from the beginning of treatment. Both are delivered by the same provider throughout treatment. |
|
| Arm 2 Sequential therapy | Experimental | Motivational enhancement therapy for addiction is delivered in the first 4 weeks and only after the addiction is addressed is the Prolonged exposure therapy for PTSD started. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure | Behavioral | Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptoms | PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms. | 16 weeks |
| Drinking Outcome | Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Oslin, MD | Philadelphia VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Minneapolis | Minneapolis | Minnesota | 55417 | United States | ||
| Philadelphia VA Medical Center, Philadelphia, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38843038 | Derived | Alpert E, Kaplan A, Nelson D, Oslin DW, Polusny MA, Ingram EP, Kehle-Forbes SM. Clusters Based on Within-Treatment Symptom Trajectories as Predictors of Dropout in Treatment for Posttraumatic Stress Disorder and Substance Use Disorder. J Dual Diagn. 2024 Jun 6:1-21. doi: 10.1080/15504263.2024.2355953. Online ahead of print. | |
| 34881912 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Integrated Care | Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment. |
| FG001 | Sequential Treatment | Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Integrated Care | Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment. |
| BG001 | Sequential Treatment | Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | PTSD Symptoms | PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
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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 | Integrated Care | Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment. |
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Both arms of the study were active treatments. There was no control conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Oslin, MD | Cpl Micheal J Crescenz VA Medical Center | 215-823-5894 | dave.oslin@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Motivational Enhancement Therapy | Behavioral | Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy. |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Scott JC, Lynch KG, Cenkner DP, Kehle-Forbes SM, Polusny MA, Gur RC, Chen S, Foa EB, Oslin DW. Neurocognitive predictors of treatment outcomes in psychotherapy for comorbid PTSD and substance use disorders. J Consult Clin Psychol. 2021 Nov;89(11):937-946. doi: 10.1037/ccp0000693. |
| 27444425 | Derived | Kehle-Forbes SM, Drapkin ML, Foa EB, Koffel E, Lynch KG, Polusny MA, Van Horn DH, Yusko DA, Charlesworth M, Blasco M, Oslin DW. Study design, interventions, and baseline characteristics for the Substance use and TRauma Intervention for VEterans (STRIVE) trial. Contemp Clin Trials. 2016 Sep;50:45-53. doi: 10.1016/j.cct.2016.07.017. Epub 2016 Jul 19. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PTSD Checklist score | PTSD Checklist score is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms. | Mean | Standard Deviation | units on a scale |
|
| Percent days of heavy drinking | Mean | Standard Deviation | percent days heavy drinking |
|
MET followed by Prolonged Exposure
|
|
| Primary | Drinking Outcome | Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes. | The number of subjects available for this measure are greater than the PTSD outcome as drinking outcomes can be obtained at anytime and thus some participants provided data at the post study evaluation. | Posted | Mean | Standard Deviation | percent days ofheavy drinking | 16 weeks |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Sequential Treatment | Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun. | 0 | 88 | 0 | 88 |
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| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |