search
Back to results

Resolving Psychological Stress (RePS)

Primary Purpose

Post-Traumatic Stress Disorder, Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RePS (Resolving Psychological Stress) - Threat ABM Training
RePS (Resolving Psychological Stress) - Neutral Attention Training
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Attention Bias Modification, PTSD, Digital Health, Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must have current PTSD symptoms.
  2. Must drink alcohol.

Exclusion Criteria:

  1. Very recent or current trauma or trauma exposure.
  2. Recent moderate or severe non-alcohol substance use disorder.
  3. Active suicidality.
  4. Lifetime history of schizophrenia or bipolar disorder I.
  5. Medical conditions including seizure disorders, neurological disorders, moderate or severe head injury, systemic illness affecting nervous system function, heart defect, or medically unstable injuries.
  6. Recent or planned change in psychotherapeutic treatment for PTSD or other psychiatric symptoms

Sites / Locations

  • Aoife O'Donovan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Threat ABM Training

Neutral Attention Training

Arm Description

Attention Bias Modification Training with threatening words

Non-active version of ABM Training

Outcomes

Primary Outcome Measures

PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days
The PTSD Checklist-5 (PCL- 5) was administered via the mobile application to assess changes in PTSD symptoms. The PCL-5 is a well validated and widely used structured 20-item diagnostic interview for assessing symptomology of PTSD corresponding to a DSM-5 diagnosis. PCL scores range from 0-80, with a score of 33 or above indicating clinically significant PTSD symptoms. Participants were asked about the severity of symptoms over the past week.
Differences in Heart Rate Variability (HRV) During a Threat Sensitivity Computerized Task
Participants will perform computerized tasks designed to assess threat sensitivity. The task contains three different "threat" conditions, regarding the possibility of receiving a small, electric shock via an electrode on the hand (shock level is set by the participant). The three conditions are: shock not possible, shock possible, and shock may be possible. HRV is measured during all conditions and differences between the three conditions are scored.

Secondary Outcome Measures

Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days
A usability assessment questionnaire was administered with multiple feasibility and acceptability questions regarding the REPS Mobile Application (Ease of use, Convenience, Enjoyment, Comfort with the app and Overall satisfaction). The responses were measured on a Five-Point Scale with 1 meaning "Not at all" and 5 meaning "Very much"." Analyses included all participants that completed the usability assessment questionnaire.

Full Information

First Posted
April 30, 2018
Last Updated
November 9, 2021
Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center, United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT03996876
Brief Title
Resolving Psychological Stress
Acronym
RePS
Official Title
Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
August 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators have developed a mobile app called Resolving Psychological Stress (REPS) to help alleviate symptoms of PTSD. The app will administer threat-related attention bias modification to individuals who have both a Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) diagnosis of PTSD (and meet at least one DSM-V criteria for threat sensitivity) and a DSM-V diagnosis of Alcohol Use Disorder. The aims of the study are to explore both the feasibility and acceptability of the app with it's users, and to explore the efficacy of the app at alleviating PTSD severity.
Detailed Description
Posttraumatic stress disorder (PTSD) is a highly disabling disorder that affects approximately 30 million people in the United States. New low-cost and accessible treatments for PTSD are desperately needed. Threat-related attention biases represent an important potential treatment target for PTSD. Such attention biases predict risk for PTSD following trauma exposure, and are thought to maintain symptoms of PTSD and other anxiety disorders. Research indicates that specific forms of computerized attention bias modification (ABM) are effective in reducing attention bias for threat as well as anxiety in patients with diverse anxiety disorders. The investigators have developed a mobile "app" called RePS (Resolving Psychological Stress) to administer threat-related ABM to patients with PTSD and Alcohol Use Disorder and have tested it in a laboratory-based pilot study of 19 people with PTSD. 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 study aims are to examine the feasibility, acceptability and usability of app-based ABM; and determine the efficacy of app-based ABM in reducing attention bias and PTSD severity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Alcohol Use Disorder
Keywords
Attention Bias Modification, PTSD, Digital Health, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
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 attention training.
Masking
Participant
Masking Description
Participants will be blind to the bias modification training they are assigned.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Threat ABM Training
Arm Type
Active Comparator
Arm Description
Attention Bias Modification Training with threatening words
Arm Title
Neutral Attention Training
Arm Type
Placebo Comparator
Arm Description
Non-active version of ABM Training
Intervention Type
Device
Intervention Name(s)
RePS (Resolving Psychological Stress) - Threat ABM Training
Intervention Description
This mobile "app" will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (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
Device
Intervention Name(s)
RePS (Resolving Psychological Stress) - Neutral Attention Training
Intervention Description
This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words.
Primary Outcome Measure Information:
Title
PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days
Description
The PTSD Checklist-5 (PCL- 5) was administered via the mobile application to assess changes in PTSD symptoms. The PCL-5 is a well validated and widely used structured 20-item diagnostic interview for assessing symptomology of PTSD corresponding to a DSM-5 diagnosis. PCL scores range from 0-80, with a score of 33 or above indicating clinically significant PTSD symptoms. Participants were asked about the severity of symptoms over the past week.
Time Frame
15 days apart
Title
Differences in Heart Rate Variability (HRV) During a Threat Sensitivity Computerized Task
Description
Participants will perform computerized tasks designed to assess threat sensitivity. The task contains three different "threat" conditions, regarding the possibility of receiving a small, electric shock via an electrode on the hand (shock level is set by the participant). The three conditions are: shock not possible, shock possible, and shock may be possible. HRV is measured during all conditions and differences between the three conditions are scored.
Time Frame
15 days apart
Secondary Outcome Measure Information:
Title
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days
Description
A usability assessment questionnaire was administered with multiple feasibility and acceptability questions regarding the REPS Mobile Application (Ease of use, Convenience, Enjoyment, Comfort with the app and Overall satisfaction). The responses were measured on a Five-Point Scale with 1 meaning "Not at all" and 5 meaning "Very much"." Analyses included all participants that completed the usability assessment questionnaire.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have current PTSD symptoms. Must drink alcohol. Exclusion Criteria: Very recent or current trauma or trauma exposure. Recent moderate or severe non-alcohol substance use disorder. Active suicidality. Lifetime history of schizophrenia or bipolar disorder I. Medical conditions including seizure disorders, neurological disorders, moderate or severe head injury, systemic illness affecting nervous system function, heart defect, or medically unstable injuries. Recent or planned change in psychotherapeutic treatment for PTSD or other psychiatric symptoms
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
Aoife O'Donovan
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Resolving Psychological Stress

We'll reach out to this number within 24 hrs