Evaluation of Web-Based CBT for Rape Victims

May 17, 2016 updated by: Heather Littleton, East Carolina University
Rape is unfortunately a common experience among women, affecting between 13 and 20%. In addition, up to 50% of all rape victims experience significant and persistent psychological distress. While cognitive-behavioral interventions have been found to be successful at alleviating distress among victims; the majority do not seek out these services, often because of feelings of stigma and self-blame. One potential method for circumventing these barriers is through online administered treatment. Thus, the current project is designed to conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media, cognitive-behavioral, online intervention tailored specifically for rape victims. The effectiveness of this program at ameliorating distress among college women who have experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated. Reductions in psychological distress was the primary outcome and was assessed at post-intervention and at three and six month follow-up periods. The effectiveness of the intervention was compared to a psycho-educational website.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Current rape-related PTSD
  • Regular access to a computer
  • English language literacy
  • Experience of completed rape at age 14 years or older

Exclusion Criteria:

  • No current PTSD
  • Current psychotherapy
  • Lack of stability on psychotropic medication (< 3 months)
  • Lack of literacy in English
  • Current substance dependence
  • Current elevated suicidality
  • Severe acute distress
  • No experience of completed rape after age 14

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Online intervention
Therapist-facilitated, cognitive behavioral therapy
Behavioral: Online intervention
Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD
ACTIVE_COMPARATOR: Psycho-educational website
Self-help, psycho-educational website
Behavioral: Psycho-educational website
Psycho-educational self-help website about rape-related PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PTSD symptoms (PTSD Symptom Scale Interview)
Time Frame: Change in PTSD symptoms from baseline to 3 months post intervention
Change in PTSD symptoms from baseline to 3 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Collaborators

Boston University
University of Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (ESTIMATE)

May 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1R34MH085118-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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