Alcohol Use Disorders (AUDs) and Post-traumatic Stress Disorder (PTSD) Treatment for Victims of Partner Violence

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.

Detailed Description
-----------------
The goal of this study is to evaluate an integrated psychotherapy for PTSD and substance use disorders among female victims of intimate partner violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use post-treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.

Official Title
-----------------
AUDs and PTSD Treatment for Victims of Partner Violence

Conditions
-----------------
PTSD, Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Integrated psychotherapy for PTSD and substance use
* Behavioral: 12-step based supportive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female victims of partner violence at least one month out of the abusive relationship meet DSM-IV (American Psychiatric Association, 1994) criteria for PTSD and an alcohol use disorder literate in English have not changed psychotropic medications or dosages within the past two months and agree not to during the active phase (first 12 weeks) of the intervention have an identified primary care physician Exclusion Criteria: moderate or severe cognitive impairment as measured by a Mini-Mental State Examination score less than or equal to 18 Histories of psychosis or mania may be excluded because the presence of these disorders is thought to impede progress in psychotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Present focused, integrated psychotherapy for PTSD and substance use disorders | Behavioral: Integrated psychotherapy for PTSD and substance use<br>* integrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence<br>|
| Active Comparator: 2<br>Supportive therapy using 12-step model | Behavioral: 12-step based supportive therapy<br>* supportive psychotherapy based on 12-step model<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS for PTSD symptoms and ASI for substance use |  | pre, mid treatment, post, 3-month follow-up, 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline Follow-back procedure, Beck Depression Inventory |  | same as primary | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, substance use disorders, psychotherapy