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

NCT ID: NCT00602069

Last Updated: 2013-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder Battered Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program

Group Type EXPERIMENTAL

Helping to Overcome PTSD through Empowerment (HOPE)

Intervention Type BEHAVIORAL

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.

2

Participants will receive standard shelter services

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Treatment as usual includes standard shelter services for abused women.

Interventions

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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.

Intervention Type BEHAVIORAL

Treatment as usual

Treatment as usual includes standard shelter services for abused women.

Intervention Type BEHAVIORAL

Other Intervention Names

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HOPE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Summa Health System

OTHER

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role collaborator

The University of Akron

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dawn M. Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Summa Health System

Locations

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University of Akron

Akron, Ohio, United States

Site Status

Countries

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United States

References

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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. doi: 10.1002/jts.20148.

Reference Type BACKGROUND
PMID: 16929512 (View on PubMed)

Johnson DM, Johnson NL, Perez SK, Palmieri PA, Zlotnick C. Comparison of Adding Treatment of PTSD During and After Shelter Stay to Standard Care in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial. J Trauma Stress. 2016 Aug;29(4):365-73. doi: 10.1002/jts.22117. Epub 2016 Jul 26.

Reference Type DERIVED
PMID: 27459503 (View on PubMed)

Other Identifiers

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R34MH080786

Identifier Type: NIH

Identifier Source: secondary_id

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DATR AD-TS

Identifier Type: -

Identifier Source: secondary_id

R34MH080786

Identifier Type: NIH

Identifier Source: org_study_id

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