Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resolving Psychological Stress (RePS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996876
Recruitment Status : Active, not recruiting
First Posted : June 25, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
San Francisco Veterans Affairs Medical Center
United States Department of Defense
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Alcohol Use Disorder Device: Threat ABM Training Device: Neutral Attention Training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to either a threat attention bias modification training or a neutral attention training.
Masking: Single (Participant)
Masking Description: Participants will be blind to the bias modification training they are assigned.
Primary Purpose: Treatment
Official Title: Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Active Comparator: Threat ABM Training
Attention Bias Modification Training with threatening words
Device: 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.

Placebo Comparator: Neutral Attention Training
Non-active version of ABM Training
Device: 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.




Primary Outcome Measures :
  1. Reduction of PTSD symptoms as captured by the Clinical Administered PTSD Scale (CAPS) [ Time Frame: 2 days ]
    The CAPS will be administered by a trained clinical interviewer and will assess changes in PTSD symptoms. The Clinician-Administered PTSD Scale (CAPS) is a well validated and widely used structured 30-item diagnostic interview for assessing symptomology of PTSD corresponding to a DSM-5 diagnosis. CAPS-5 Provides information on current and lifetime PTSD symptoms and status; providing a diagnosis, frequency, and intensity of symptoms.

  2. Differences in heart rate variability (HRV) during a threat sensitivity computerized task [ Time Frame: 2 days ]
    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.


Secondary Outcome Measures :
  1. Score of a questionnaire assessing feasibility and acceptability of the Attention Bias Modification (ABM) application [ Time Frame: 1 day ]
    Participants will report if REPS is acceptable in multiple areas (e.g. ease of use, ability to maintain attention and motivation for training, enjoyment of the task) as measured by responses on a self-report questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996876


Locations
Layout table for location information
United States, California
Aoife O'Donovan
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Aoife S O'Donovan, Ph.D. University of California, San Francisco

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03996876     History of Changes
Other Study ID Numbers: 12-10411
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of California, San Francisco:
Attention Bias Modification
PTSD
Digital Health
Alcohol Use Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Alcoholism
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Alcohol Drinking
Stress, Psychological
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Behavioral Symptoms