Remotely Resolving Psychological Stress (Remote RePS)

Post Traumatic Stress Disorder Clinical Trial

Official title:

Remote RePS: An Entirely Remote Study of an Attention Bias Modification Training "App" for Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196999
• Other study ID #: 17-22529
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: December 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators have developed a mobile app called Resolving Psychological Stress (REPS) for people with posttraumatic stress disorder (PTSD). The app will administer threat-related attention bias modification to individuals who score high on a PTSD checklist. This study will be administered remotely to individuals in the United States. The aims of the study are to explore feasibility, acceptability and usability of the app in an entirely remote study, as well as to explore the efficacy of the app at reducing attention bias and PTSD symptom severity.

Description:

Posttraumatic stress disorder (PTSD) is a highly disabling disorder that affects approximately 8% of the population worldwide. Threat-related attention biases represent an important mechanism that may underlie PTSD symptoms. Such attention biases predict risk for PTSD following trauma exposure, and are thought to maintain some symptoms of PTSD. Research indicates that specific forms of computerized attention bias modification (ABM) training are effective in reducing attention bias for threat. We have developed a mobile app called REPS (Resolving Psychological Stress) to administer threat-related ABM training to people with symptoms of PTSD and have tested it in a laboratory-based pilot study of 22 people with elevated PTSD symptoms. Our preliminary data indicate that the app is highly acceptable to patients and that use of the app reduces attention bias for threat and PTSD symptom severity. The proposed study will expand on this prior lab-based study to test ABM training on an app entirely remotely. Our primary aim is to examine the feasibility, acceptability and usability of remotely administered app-based ABM training and to determine the efficacy of remote app-based ABM training in reducing attention bias and PTSD symptom severity. Our secondary aim is to examine whether a personalized version of ABM training results in greater attentional bias change and anxiety reduction compared to a non-personalized ABM training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must own an iOS device compatible with the app (i.e. iPhones or iPod Touches)

• Must score at or above 33 on PTSD Checklist (PCL-5), which indicates clinically significant PTSD symptoms.

Exclusion Criteria:

• Active suicidal ideation.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Personalized Attention Bias Training
This self-help program will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing a low-cost and highly scalable self-help tool to alleviate symptoms of PTSD. The app can be used on an iOS compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be personalized for each user.
• Neutral Attention Training Condition
This self-help program is a placebo control program that will be used on an iOS compatible phone. The placebo will contain only neutral words.
• Non-Personalized Attention Bias Training
This self-help program administered on an app will aim to reduce neurobiological threat sensitivity with the ultimate goal of a low-cost and highly scalable self-help tool to alleviate symptoms of PTSD. The app can be used on an iOS compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability, feasibility and usability of completing attention bias modification via a mobile app.	To examine a usability survey in which participants rate their experience of completing attention bias modification via a mobile app. Specifically, the questions regard the acceptability, feasibility, and usability to a completely remote, clinical population.	Two weeks
Primary	Reduction in post traumatic stress disorder (PTSD) symptoms	To examine if remote app-based attention bias modification training compared to control neutral attention training reduces scores on the PTSD Checklist (PCL-5), an indication of PTSD symptom severity.	Two weeks
Secondary	Reduction of PTSD Checklist (PCL) score with personalized attention bias modification	To examine if remote app-based personalized attention bias modification training (uses personalized stimuli in the training) compared to non-personalized attention bias modification training (uses a standard set of stimuli) reduces PTSD symptoms via the PCL.	Two weeks