Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Treatment of PTSD in Recently Battered Women Living in Shelters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602069
• Other study ID #: R34MH080786
• Secondary ID: R34MH080786DATR
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2008
• Last updated: June 21, 2013
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: June 2013
• Source: The University of Akron
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress disorder who are living in shelters.

Description:

Intimate partner violence is a serious social problem with potentially severe mental health and functional consequences consistent with post-traumatic stress disorder (PTSD). Shelters provide an important resource for abused women in that they offer emergency shelter, support, and access to community resources that can aid in establishing long-term safety for women and their children. However, recent research suggests that symptoms of PTSD can compromise abused women's ability to access and effectively use these resources, emphasizing the importance of initiating treatment for PTSD. Despite the fact that on an annual basis 300,000 battered women and children access shelter services, virtually no research has investigated treatment of PTSD in sheltered abused women. A woman's entry into a shelter seems to be a prime time to begin any necessary psychological treatment. Helping to Overcome PTSD through Empowerment (HOPE), a brief cognitive behavioral treatment that emphasizes stabilization and empowerment of women, may help in treating abused women with PTSD. This study will evaluate the effectiveness of HOPE in treating abused women with PTSD who are in shelters.

Participation in this single-blind study will begin during a woman's shelter stay and will end 8 months after she completes the shelter treatment period. All potential participants will first undergo an initial interview, which will include questions about their abusive relationships, emotional difficulties, stressful events, and other previous treatments. Participants invited to continue with the study will be randomly assigned to the HOPE program or to shelter treatment as usual. Participants assigned to the HOPE program will participate in a maximum of 16 counseling sessions, with up to 10 of these sessions taking place while they are at the shelter. During these sessions, participants will learn skills to help manage emotional difficulties and ways to deal with their abusive relationships. Participants will attend two 60- to 90-minute sessions each week until they complete of the 10 shelter-based counseling sessions or depart from the shelter. Counseling sessions will continue at St. Thomas Hospital or other agreed-upon location twice per week during the first 8 weeks after departure from the shelter. All participants will repeat the initial interview and/or questionnaire at various times during and after the shelter stay, for a total of eight assessments. The final interview assessment will occur 6 months after participants complete the counseling sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meets criteria for PTSD or subthreshold PTSD

• Resident of a battered women's shelter

• Abused in the month prior to study entry

Exclusion Criteria:

• Significant suicidal ideation or risk

• Current psychotic symptoms

• Current alcohol or drug dependence

• Lifetime history of bipolar disorder

• Concurrent psychosocial treatment

• Any change in medication in the month prior to study entry

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Battered Women
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Helping to Overcome PTSD through Empowerment (HOPE)
HOPE includes a maximum of 16 sessions of cognitive behavioral therapy. The sessions will emphasize stabilization and empowerment, both of which are identified as important goals by the theoretical and empirical literature on abused women and PTSD.
• Treatment as usual
Treatment as usual includes standard shelter services for abused women.

Locations

Country	Name	City	State
United States	University of Akron	Akron	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
The University of Akron	Butler Hospital, National Institute of Mental Health (NIMH), Summa Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Johnson DM, Zlotnick C. A cognitive-behavioral treatment for battered women with PTSD in shelters: findings from a pilot study. J Trauma Stress. 2006 Aug;19(4):559-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptom severity		Measured at Month 8	No
Secondary	Effective use of resources		Measured at Month 8	No
Secondary	Resource loss		Measured at Month 8	No
Secondary	Depression		Measured at Month 8	No
Secondary	Social functioning		Measured at Month 8	No
Secondary	Revictimization		Measured at Month 8	Yes