Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486692
Other study ID # PPO 14-360
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date December 2016

Study information

Verified date May 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the AboutFace peer education website for the purpose of reducing stigma and improving attitudes toward seeking mental health services among Veterans.


Description:

Research suggests that at least 1 in 10 Veterans will meet criteria for posttraumatic stress disorder (PTSD) related to their military experience. Treatment is widely available to Veterans with PTSD, and national dissemination initiatives have increased Veterans' access to best practice interventions. However, treatment seeking remains strikingly low among Veterans with PTSD. In fact, most Veterans with PTSD do not seek mental health services due to perceived stigma and other associated barriers. The National Center for PTSD recently developed and launched AboutFace, a peer education resource for Veterans. The investigators of this study believe that AboutFace has tremendous potential to reduce stigma and improve attitudes toward seeking mental health services among Veterans. However, it has not yet been evaluated. Investigators have partnered with the National Center for PTSD to launch this mixed methods pilot evaluation of AboutFace. There will be two phases to this study. During Phase I- Usability, 20 Veterans will be recruited to participate in individual interviews during which they will be asked to describe the ease of use of the AboutFace website for the researchers. During Phase II- Feasibility, 60 Veterans will be randomized to one of two conditions- About Face or Usual Care. All participants will complete several brief assessments measuring PTSD symptoms and attitudes toward seeking mental health services. Participants will then be randomized to either receive a link to the About Face website or to receive a link to a general online brochure about PTSD. After two weeks, participants will complete the assessment measures once again to determine any changes in attitudes toward seeking mental health services and potential changes in PTSD symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be 18 years of age

- Recommended for PTSD treatment following evaluation

- Internet access

- English Speaking

Exclusion Criteria:

- Minors under the age of 18

- Non-Veterans

- Negative for PTSD

Study Design


Related Conditions & MeSH terms


Intervention

Other:
AboutFace Website
AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and different treatments for PTSD.

Locations

Country Name City State
United States Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kreuze E, Jenkins C, Gregoski M, York J, Mueller M, Lamis DA, Ruggiero KJ. Technology-enhanced suicide prevention interventions: A systematic review. J Telemed Telecare. 2017 Jul;23(6):605-617. doi: 10.1177/1357633X16657928. Epub 2016 Jul 3. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Endorsed and Anticipated Stigma Inventory (EASI) THE EASI assesses for perceptions of treatment effectiveness, stigma, and external barriers to treatment seeking. Answers are ranked from 1 to 5 with 1 being "Strongly Disagree" and 5 being "Strongly Agree" and higher scores are indicative of greater stigma. Total scores can range from 40 to 190.
Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
pre-treatment (baseline) & post-treatment (two-week) assessment
Primary PTSD Checklist (PCL-V) The PCL-V is a 20-item self-report measure that assesses PTSD severity. Individual item responses can range from 0-4 with 0 being "Not At All" and 4 being "Extremely" and total scores can range from 0 to 80. Higher numbers on the PCL-V are indicative of greater PTSD severity.
Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
pre-treatment (baseline) & post-treatment (2-week) assessment
Primary PTSD Treatment Initiators percentage/rate of PTSD treatment initiation at post assessment (2-weeks) Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure. two weeks post assessment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962504 - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT06278922 - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma N/A
Completed NCT04597450 - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT03429166 - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas N/A
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT03504722 - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD N/A
Completed NCT04305353 - Intensive Care Unit (ICU) Diary Project N/A
Completed NCT03113890 - McLean and Genomind Prospective Study N/A
Withdrawn NCT05173831 - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Phase 2
Not yet recruiting NCT04056767 - Changes in Digital Phenotype During PE Therapy
Withdrawn NCT03924297 - Chilipad for Sleep and Symptoms of PTSD N/A
Completed NCT03158558 - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD N/A
Completed NCT03343028 - Biomarker Establishment for Superior Treatment of PTSD
Withdrawn NCT03216356 - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD Phase 2/Phase 3
Completed NCT02370173 - A Non-Pharmacological Method for Enhancing Sleep in PTSD N/A
Completed NCT01955538 - The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees. Phase 3
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A