Clinical trial NCT00607412: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Substance Use Disorders
Keywords: PTSD
substance use disorders
psychotherapy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CAPS for PTSD symptoms and ASI for substance use
timeFrame: pre, mid treatment, post, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Timeline Follow-back procedure, Beck Depression Inventory
timeFrame: same as primary
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Outpatient Psychiatry
state: California
Study officials:
affiliation: UCSD
name: Sonya Norman
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.