N/A
N=28
Resolving Psychological Stress
Post-Traumatic Stress Disorder · Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03996876 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days — 33.2; 36.6; 31.2; 28.2 units on a scale — p=0.322
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RePS (Resolving Psychological Stress) - Threat ABM Training (Device); RePS (Resolving Psychological Stress) - Neutral Attention Training (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days |
33.2; 36.6; 31.2; 28.2 | 0.322 |
| PRIMARY Differences in Heart Rate Variability (HRV) During a Threat Sensitivity Computerized Task |
— | — |
| SECONDARY 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 |
4.56; 4.52; 4.02; 3.92; 3.29; 3.18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Must have current PTSD symptoms.
- Must drink alcohol.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03996876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.