Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder
Primary Purpose
Post-Traumatic Stress Disorder, Battered Women
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Helping to Overcome PTSD through Empowerment (HOPE)
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Intimate Partner Violence, Cognitive Behavioral Therapy, Empowerment
Eligibility Criteria
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
Sites / Locations
- University of Akron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program
Participants will receive standard shelter services
Outcomes
Primary Outcome Measures
PTSD symptom severity
Secondary Outcome Measures
Effective use of resources
Resource loss
Depression
Social functioning
Revictimization
Full Information
NCT ID
NCT00602069
First Posted
January 18, 2008
Last Updated
June 21, 2013
Sponsor
The University of Akron
Collaborators
National Institute of Mental Health (NIMH), Summa Health System, Butler Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00602069
Brief Title
Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder
Official Title
Treatment of PTSD in Recently Battered Women Living in Shelters
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Akron
Collaborators
National Institute of Mental Health (NIMH), Summa Health System, Butler Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Battered Women
Keywords
PTSD, Intimate Partner Violence, Cognitive Behavioral Therapy, Empowerment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive standard shelter services
Intervention Type
Behavioral
Intervention Name(s)
Helping to Overcome PTSD through Empowerment (HOPE)
Other Intervention Name(s)
HOPE
Intervention Description
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
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual includes standard shelter services for abused women.
Primary Outcome Measure Information:
Title
PTSD symptom severity
Time Frame
Measured at Month 8
Secondary Outcome Measure Information:
Title
Effective use of resources
Time Frame
Measured at Month 8
Title
Resource loss
Time Frame
Measured at Month 8
Title
Depression
Time Frame
Measured at Month 8
Title
Social functioning
Time Frame
Measured at Month 8
Title
Revictimization
Time Frame
Measured at Month 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M. Johnson, PhD
Organizational Affiliation
Summa Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44325
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16929512
Citation
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.
Results Reference
background
PubMed Identifier
27459503
Citation
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.
Results Reference
derived
Learn more about this trial
Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder
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