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Remotely Resolving Psychological Stress (Remote RePS)

NCT ID: NCT03196999

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2018-11-01

Brief Summary

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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

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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.

Conditions

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Post Traumatic Stress Disorder

Keywords

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PTSD Attention bias modification Remote app-based study Digital Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to either a threat attention bias modification training or a neutral bias modification training.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will be blind to which condition they will be in.

Study Groups

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Personalized Attention Bias Training

Personalized version of ABM Training.

Group Type ACTIVE_COMPARATOR

Personalized Attention Bias Training

Intervention Type 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.

Neutral Attention Training Condition

Non-active version of ABM training.

Group Type PLACEBO_COMPARATOR

Neutral Attention Training Condition

Intervention Type 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.

Non-Personalized Attention Bias Training

Non-personalized version of ABM training.

Group Type ACTIVE_COMPARATOR

Non-Personalized Attention Bias Training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aoife S O'Donovan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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17-22529

Identifier Type: -

Identifier Source: org_study_id