Resolving Psychological Stress

NCT03996876 | Completed Results FDA Device

• 1 other identifier: 12-10411
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder; Alcohol Use Disorder

Keywords

Attention Bias Modification; PTSD; Digital Health; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

  15 days

Study Arms (2)

Threat ABM Training

ACTIVE COMPARATOR

Attention Bias Modification Training with threatening words

Device: RePS (Resolving Psychological Stress) - Threat ABM Training

Neutral Attention Training

PLACEBO COMPARATOR

Non-active version of ABM Training

Device: RePS (Resolving Psychological Stress) - Neutral Attention Training

Interventions

RePS (Resolving Psychological Stress) - Threat ABM Training 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.

Threat ABM Training

RePS (Resolving Psychological Stress) - Neutral Attention Training 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.

Neutral Attention Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have current PTSD symptoms.
• Must drink alcohol.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Aoife O'Donovan

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Limitations and Caveats

Sample size is limited and results should be interpreted cautiously.

Results Point of Contact

• Title: Aoife O'Donovan, Associate Professor of Psychiatry
• Organization: University of California, San Francisco

aoife.odonovan@ucsf.edu

4152214810

Study Officials

• Aoife S O'Donovan, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blind to the bias modification training they are assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to either a threat attention bias modification training or a neutral attention training.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 25, 2019
• Study Start: January 9, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 16, 2019
• Last Updated: December 7, 2021
• Results First Posted: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)