Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
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Purpose
This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).
| Condition | Intervention |
|---|---|
|
Stress Disorders, Post-Traumatic |
Behavioral: Psychotherapy treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD |
- outcome [ Time Frame: within study timeframe ] [ Designated as safety issue: No ]
| Enrollment: | 144 |
| Study Start Date: | April 2002 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: study arm | Behavioral: Psychotherapy treatment |
Detailed Description:
PTSD is a debilitating and often chronic anxiety disorder with serious psychiatric comorbidity. The most common trauma associated with PTSD among women is childhood abuse. PTSD related to childhood abuse may cause problems with emotion regulation and interpersonal functioning. This study will address three domains of PTSD related to childhood abuse: emotion management problems, interpersonal problems, and PTSD symptoms.
Participants in this study will be randomly assigned to 16 sessions of one of three treatments: Skills Training for Affective and Interpersonal Regulation (STAIR), which focuses on helping individuals strengthen and build skills in managing feelings and improving interpersonal relationships; Modified Prolonged Exposure (MPE), which focuses on developing narratives of abuse history and completing an "emotional processing" of the trauma in a safe environment; and a combination of STAIR and MPE. Dropout rates and adverse effects will be measured.
Eligibility| Ages Eligible for Study: | 22 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- DSM-IV criteria for Post-Traumatic Stress Disorder related to childhood physical and/or sexual abuse by a care-giver
- At least one clear memory of the abuse
- Willing to have all assessments tape recorded and sessions video taped
- Willing to maintain any concurrent treatments for the duration of the study
Exclusion Criteria:
- Bipolar Disorder
- Eating Disorder
- Borderline Personality Disorder
- Active substance abuse or dependence
- Living with the abuser
- Self mutilation
- Pregnancy
Contacts and Locations More Information
Additional Information:
No publications provided by New York University School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00069381 History of Changes |
| Other Study ID Numbers: | R01 MH62347, R01MH062347, DSIR 83-ATAS |
| Study First Received: | September 24, 2003 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013