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Remotely Resolving Psychological Stress (Remote RePS)

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Attention Bias Training
Neutral Attention Training Condition
Non-Personalized Attention Bias Training
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorder focused on measuring PTSD, Attention bias modification, Remote app-based study, Digital Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Personalized Attention Bias Training

Neutral Attention Training Condition

Non-Personalized Attention Bias Training

Arm Description

Personalized version of ABM Training.

Non-active version of ABM training.

Non-personalized version of ABM training.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 20, 2017
Last Updated
December 5, 2018
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03196999
Brief Title
Remotely Resolving Psychological Stress (Remote RePS)
Official Title
Remote RePS: An Entirely Remote Study of an Attention Bias Modification Training "App" for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD, Attention bias modification, Remote app-based study, Digital Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either a threat attention bias modification training or a neutral bias modification training.
Masking
Participant
Masking Description
Participants will be blind to which condition they will be in.
Allocation
Randomized
Enrollment
528 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized Attention Bias Training
Arm Type
Active Comparator
Arm Description
Personalized version of ABM Training.
Arm Title
Neutral Attention Training Condition
Arm Type
Placebo Comparator
Arm Description
Non-active version of ABM training.
Arm Title
Non-Personalized Attention Bias Training
Arm Type
Active Comparator
Arm Description
Non-personalized version of ABM training.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Attention Bias Training
Intervention Description
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
Intervention Name(s)
Neutral Attention Training Condition
Intervention Description
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
Intervention Name(s)
Non-Personalized Attention Bias Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability, feasibility and usability of completing attention bias modification via a mobile app.
Description
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.
Time Frame
Two weeks
Title
Reduction in post traumatic stress disorder (PTSD) symptoms
Description
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.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Reduction of PTSD Checklist (PCL) score with personalized attention bias modification
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aoife S O'Donovan, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Remotely Resolving Psychological Stress (Remote RePS)

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