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Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder
This study is currently recruiting participants.
Study NCT00602069   Information provided by National Institute of Mental Health (NIMH)
First Received: January 18, 2008   Last Updated: March 9, 2009   History of Changes

January 18, 2008
March 9, 2009
May 2008
August 2010   (final data collection date for primary outcome measure)
PTSD symptom severity [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00602069 on ClinicalTrials.gov Archive Site
  • Effective use of resources [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Resource loss [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Social functioning [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Revictimization [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: Yes ]
Same as current
 
Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder
Treatment of PTSD in Recently Battered Women Living in Shelters

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.

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.

Phase I
Interventional
Treatment, Randomized, Single Blind (Investigator), Parallel Assignment
  • Post-Traumatic Stress Disorder
  • Battered Women
  • Behavioral: Helping to Overcome PTSD through Empowerment (HOPE)
  • Behavioral: Treatment as usual
  • Experimental: Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program
  • Active Comparator: Participants will receive standard shelter services
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Dawn M. Johnson, PhD 330-379-5401
United States
 
NCT00602069
Dawn M. Johnson, PhD/PI, University of Akron
R34 MH080786, DATR AD-TS
National Institute of Mental Health (NIMH)
  • The University of Akron
  • Summa Health System
  • Butler Hospital
Principal Investigator: Dawn M. Johnson, PhD Summa Health System
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP