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
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder Alcohol Use Disorder||Device: Threat ABM Training Device: Neutral Attention Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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 Description:||Participants will be blind to the bias modification training they are assigned.|
|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|
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.
- 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.
- 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.
- 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.
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
|United States, California|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Aoife S O'Donovan, Ph.D.||University of California, San Francisco|