Remotely Resolving Psychological Stress (Remote RePS)

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Neutral Attention Training Condition; Behavioral: Non-Personalized Attention Bias Training; Behavioral: Personalized Attention Bias Training

• Registration Number: NCT03196999
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-23
• Study Start: 2017-11-30
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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.

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Exclusion Criteria

• Active suicidal ideation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral Attention Training Condition	Neutral Attention Training Condition	Non-active version of ABM training.
Non-Personalized Attention Bias Training	Non-Personalized Attention Bias Training	Non-personalized version of ABM training.
Personalized Attention Bias Training	Personalized Attention Bias Training	Personalized version of ABM Training.

Primary Outcome Measures

Name	Time	Method
Acceptability, feasibility and usability of completing attention bias modification via a mobile app.	Two weeks	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.
Reduction in post traumatic stress disorder (PTSD) symptoms	Two weeks	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.

Secondary Outcome Measures

Name	Time	Method
Reduction of PTSD Checklist (PCL) score with personalized attention bias modification	Two weeks	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States