PTSDNCT02777294
Evaluation of Web-Based CBT for Rape Victims
A study testing Online intervention and Psycho-educational website in people with PTSD, run by East Carolina University.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Online intervention and Psycho-educational website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current rape-related PTSD
- Regular access to a computer
- English language literacy
- Experience of completed rape at age 14 years or older
Who cannot join
- 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
About this study
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.
- Conditions
- PTSD
- Being tested
- Online intervention, Psycho-educational website
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online interventionBehavioural
Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD
Psycho-educational websiteBehavioural
Psycho-educational self-help website about rape-related PTSD
| Study group | Role | What they receive |
|---|---|---|
| Online intervention | Experimental | Therapist-facilitated, cognitive behavioral therapy Receives: Behavioral: Online intervention |
| Psycho-educational website | Active comparator | Self-help, psycho-educational website Receives: Behavioral: Psycho-educational website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms (PTSD Symptom Scale Interview)
Measured: Change in PTSD symptoms from baseline to 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Houston
- Responsible party
- Principal investigator, Heather Littleton, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777294
- Sponsor's protocol ID
- 1R34MH085118-01A2
- Status last verified
- May 2016
- First submitted
- 16 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37795783
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Web-Based CBT for Rape Victims
- ClinicalTrials.gov ID
- NCT02777294
- Acronym / sponsor ID
- 1R34MH085118-01A2
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Boston University, University of Houston
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online intervention | Experimental | Behavioral: Online interventionTherapist-facilitated, cognitive behavioral therapy |
| Psycho-educational website | Active comparator | Behavioral: Psycho-educational websiteSelf-help, psycho-educational website |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current rape-related PTSD
- Regular access to a computer
- English language literacy
- Experience of completed rape at age 14 years or older
Key exclusion criteria (8 listed)
- No current PTSD
- Current psychotherapy
- Lack of stability on psychotropic medication (< 3 months)
- Lack of literacy in English
- Current substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online interventionTherapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD | Behavioural | Online intervention |
| Psycho-educational websitePsycho-educational self-help website about rape-related PTSD | Behavioural | Psycho-educational website |
Primary outcome
Change in PTSD symptoms (PTSD Symptom Scale Interview)
Time frame: Change in PTSD symptoms from baseline to 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Derived from this study: PubMed 37795783O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Online intervention and Psycho-educational website in people with PTSD, run by East Carolina University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms (PTSD Symptom Scale Interview) (time frame: Change in PTSD symptoms from baseline to 3 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02777294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.