Remotely Resolving Psychological Stress (Remote RePS)

NCT03196999 | Completed

• 1 other identifier: 17-22529
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; Attention bias modification; Remote app-based study; Digital Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Reduction of PTSD Checklist (PCL) score with personalized attention bias modification

  Two weeks

Study Arms (3)

Personalized Attention Bias Training

ACTIVE COMPARATOR

Personalized version of ABM Training.

Behavioral: Personalized Attention Bias Training

Neutral Attention Training Condition

PLACEBO COMPARATOR

Non-active version of ABM training.

Behavioral: Neutral Attention Training Condition

Non-Personalized Attention Bias Training

ACTIVE COMPARATOR

Non-personalized version of ABM training.

Behavioral: Non-Personalized Attention Bias Training

Interventions

Personalized Attention Bias Training BEHAVIORAL

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.

Personalized Attention Bias Training

Neutral Attention Training Condition BEHAVIORAL

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.

Neutral Attention Training Condition

Non-Personalized Attention Bias Training BEHAVIORAL

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.

Non-Personalized Attention Bias Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active suicidal ideation.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Aoife S O'Donovan, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blind to which condition they will be in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to either a threat attention bias modification training or a neutral bias modification training.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: November 30, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

US (1)