NCT02777294

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

May 16, 2016

Last Update Submit

May 17, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD symptoms (PTSD Symptom Scale Interview)

    Change in PTSD symptoms from baseline to 3 months post intervention

Study Arms (2)

Online intervention

EXPERIMENTAL

Therapist-facilitated, cognitive behavioral therapy

Behavioral: Online intervention

Psycho-educational website

ACTIVE COMPARATOR

Self-help, psycho-educational website

Behavioral: Psycho-educational website

Interventions

Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD

Online intervention

Psycho-educational self-help website about rape-related PTSD

Psycho-educational website

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 19, 2016

Study Start

May 1, 2012

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

May 19, 2016

Record last verified: 2016-05