Resolving Psychological Stress (RePS)

Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; Post-Traumatic Stress Disorder
• Intervention / Treatment: Device: RePS (Resolving Psychological Stress) - Threat ABM Training; Device: RePS (Resolving Psychological Stress) - Neutral Attention Training

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • Aoife O'Donovan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Threat ABM Training; Attention Bias Modification Training with threatening words	Device: RePS (Resolving Psychological Stress) - Threat ABM Training; 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.
Placebo Comparator: Neutral Attention Training; Non-active version of ABM Training	Device: RePS (Resolving Psychological Stress) - Neutral Attention Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 days apart
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.	15 days apart

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: United States Department of Defense; San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: Aoife S O'Donovan, Ph.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): August 16, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; Digital Health; Alcohol Use Disorder; Attention Bias Modification
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Trauma and Stressor Related Disorders; Alcohol Drinking; Alcoholism; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress, Psychological
• Other Study ID Numbers: 12-10411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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