Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse

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

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2009-07-31

Brief Summary

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This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).

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Detailed Description

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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.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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study arm

Group Type EXPERIMENTAL

Psychotherapy treatment

Intervention Type BEHAVIORAL

Interventions

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Psychotherapy treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No