Resolving Psychological Stress

NCT ID: NCT03996876

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2019-08-16

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.

Conditions

Post-Traumatic Stress Disorder; Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Threat ABM Training

Attention Bias Modification Training with threatening words

Group Type: ACTIVE_COMPARATOR

RePS (Resolving Psychological Stress) - Threat ABM Training

Intervention Type: DEVICE

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.

Neutral Attention Training

Non-active version of ABM Training

Group Type: PLACEBO_COMPARATOR

RePS (Resolving Psychological Stress) - Neutral Attention Training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aoife S O'Donovan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Aoife O'Donovan

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

12-10411

Identifier Type: -

Identifier Source: org_study_id