Clinical trial NCT03996876: Resolving Psychological Stress
Official title: Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Alcohol Use Disorder
Keywords: Attention Bias Modification
PTSD
Digital Health
Alcohol Use Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
name: United States Department of Defense
First posted: 2019-06-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either a threat attention bias modification training or a neutral attention training.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days
timeFrame: 15 days apart
measure: Differences in Heart Rate Variability (HRV) During a Threat Sensitivity Computerized Task
timeFrame: 15 days apart
Secondary outcomes:
measure: 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
timeFrame: 15 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Aoife O'Donovan
state: California
Study officials:
affiliation: University of California, San Francisco
name: Aoife S O'Donovan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: