NCT00607412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 11, 2011

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

December 26, 2007

Last Update Submit

May 10, 2011

Conditions

Keywords

PTSDsubstance use disorderspsychotherapy

Outcome Measures

Primary Outcomes (1)

  • CAPS for PTSD symptoms and ASI for substance use

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

Secondary Outcomes (1)

  • Timeline Follow-back procedure, Beck Depression Inventory

    same as primary

Study Arms (2)

1

EXPERIMENTAL

Present focused, integrated psychotherapy for PTSD and substance use disorders

Behavioral: Integrated psychotherapy for PTSD and substance use

2

ACTIVE COMPARATOR

Supportive therapy using 12-step model

Behavioral: 12-step based supportive therapy

Interventions

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

1

supportive psychotherapy based on 12-step model

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Outpatient Psychiatry

San Diego, California, 92103, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Sonya Norman

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 5, 2008

Study Start

August 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 11, 2011

Record last verified: 2009-06

Locations