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

Primary Purpose

PTSD, Substance Use Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Integrated psychotherapy for PTSD and substance use

12-step based supportive therapy

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, substance use disorders, psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

UCSD Outpatient Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Present focused, integrated psychotherapy for PTSD and substance use disorders

Supportive therapy using 12-step model

Outcomes

Primary Outcome Measures

CAPS for PTSD symptoms and ASI for substance use

Secondary Outcome Measures

Timeline Follow-back procedure, Beck Depression Inventory

Full Information

NCT ID

NCT00607412

First Posted

December 26, 2007

Last Updated

May 10, 2011

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT00607412

Brief Title

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

Official Title

AUDs and PTSD Treatment for Victims of Partner Violence

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, San Diego

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD, Substance Use Disorders

Keywords

PTSD, substance use disorders, psychotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Present focused, integrated psychotherapy for PTSD and substance use disorders

Arm Title

Arm Type

Active Comparator

Arm Description

Supportive therapy using 12-step model

Intervention Type

Behavioral

Intervention Name(s)

Integrated psychotherapy for PTSD and substance use

Intervention Description

integrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence

Intervention Type

Behavioral

Intervention Name(s)

12-step based supportive therapy

Intervention Description

supportive psychotherapy based on 12-step model

Primary Outcome Measure Information:

Title

CAPS for PTSD symptoms and ASI for substance use

Time Frame

pre, mid treatment, post, 3-month follow-up, 6-month follow-up

Secondary Outcome Measure Information:

Title

Timeline Follow-back procedure, Beck Depression Inventory

Time Frame

same as primary

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonya Norman

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Outpatient Psychiatry

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32608505

Citation

Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.

Results Reference

derived

PubMed Identifier

26515712

Citation

Myers US, Browne KC, Norman SB. Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. J Dual Diagn. 2015;11(3-4):238-47. doi: 10.1080/15504263.2015.1113762.

Results Reference

derived

Learn more about this trial

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

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