Evaluation of Web-Based CBT for Rape Victims

PTSD Clinical Trial

Official title:

Evaluation of Web-Based CBT for Rape Victims

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777294
• Other study ID #: 1R34MH085118-01A2
• Status: Completed
• Phase: N/A
• First received: May 16, 2016
• Last updated: May 17, 2016
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2016
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Online intervention
Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD
• Psycho-educational website
Psycho-educational self-help website about rape-related PTSD

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
East Carolina University	Boston University, University of Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptoms (PTSD Symptom Scale Interview)		Change in PTSD symptoms from baseline to 3 months post intervention	No