Remotely Resolving Psychological Stress (Remote RePS)

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

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Personalized Attention Bias Training; Behavioral: Neutral Attention Training Condition; Behavioral: Non-Personalized Attention Bias Training

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 Type: Interventional
• Enrollment (Actual): 528
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Personalized Attention Bias Training; Personalized version of ABM Training.	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.
Placebo Comparator: Neutral Attention Training Condition; Non-active version of ABM training.	Behavioral: 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.
Active Comparator: Non-Personalized Attention Bias Training; Non-personalized version of ABM training.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Aoife S O'Donovan, Ph.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: PTSD; Digital Health; Attention bias modification; Remote app-based study
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 17-22529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No