Resolving Psychological Stress (RePS)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Post-Traumatic Stress Disorder; Alcohol Use Disorder

Treatments: Device: RePS (Resolving Psychological Stress) - Threat ABM Training; Device: RePS (Resolving Psychological Stress) - Neutral Attention Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03996876

12-10411

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

Threat ABM Training

Active Comparator group

Description:

Attention Bias Modification Training with threatening words

Treatment:

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

Neutral Attention Training

Placebo Comparator group

Description:

Non-active version of ABM Training

Treatment:

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