Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault

NCT00057629 | Completed Phase 2 DMC

• 2 other identifiers: R01MH042178DSIR AT-AS
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post Traumatic Stress Disorder (PTSD).

Conditions

Stress Disorders, Post-Traumatic

Keywords

Rape; Sex Offenses

Outcome Measures

Primary Outcomes (1)

• Severity of PTSD, depression, anxiety and general function

  Measured pre- and post-treatment

Study Arms (2)

1 Prolonged Exposure

ACTIVE COMPARATOR

Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.

Behavioral: Prolonged Exposure (PE)

2 Individual and group therapy

ACTIVE COMPARATOR

TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises. Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.

Behavioral: Treatment as usual group therapy (TUGT); Behavioral: Supportive counseling (SC)

Interventions

Prolonged Exposure (PE) BEHAVIORAL

Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.

1 Prolonged Exposure

Treatment as usual group therapy (TUGT) BEHAVIORAL

TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises. TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another.

2 Individual and group therapy

Supportive counseling (SC) BEHAVIORAL

Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions. During this treatment, the therapist helps the patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The therapist uses active listening, encouragement of expression of feelings, praise, and encouragement. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these. No instructions for exposure are given.

2 Individual and group therapy

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV criteria for PTSD at least 12 weeks after sexual assault
• PTSD symptoms that result from sexual assault and not from another traumatic experience

You may not qualify if:

• DSM-IV criteria for schizophrenia or delusional disorder
• Unstable bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment. Clients who are medicated and still meet current criteria for these disorders will be excluded.
• Substance dependence
• Continued intimate relationship with the assailant

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Center for the Treatment and Study of Anxiety, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Women Organized Against Rape (WOAR)

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Elizabeth A Hembree, PhD

  University of Pennsylvania Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2003
• First Posted: April 7, 2003
• Study Start: January 1, 2002
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2009
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (2)