- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777294
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
|
Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD
|
ACTIVE_COMPARATOR: Psycho-educational website
Self-help, 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
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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