Clinical trial NCT03196999: Remotely Resolving Psychological Stress (Remote RePS)
Official title: Remote RePS: An Entirely Remote Study of an Attention Bias Modification Training "App" for Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Attention bias modification
Remote app-based study
Digital Health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 528
Sex: ALL
Minimum age (years): 18
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 bias modification training.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators have developed a mobile app called Resolving Psychological Stress (REPS) for people with posttraumatic stress disorder (PTSD). The app will administer threat-related attention bias modification to individuals who score high on a PTSD checklist. This study will be administered remotely to individuals in the United States. The aims of the study are to explore feasibility, acceptability and usability of the app in an entirely remote study, as well as to explore the efficacy of the app at reducing attention bias and PTSD symptom severity.

Detailed description: Posttraumatic stress disorder (PTSD) is a highly disabling disorder that affects approximately 8% of the population worldwide. Threat-related attention biases represent an important mechanism that may underlie PTSD symptoms. Such attention biases predict risk for PTSD following trauma exposure, and are thought to maintain some symptoms of PTSD. Research indicates that specific forms of computerized attention bias modification (ABM) training are effective in reducing attention bias for threat. We have developed a mobile app called REPS (Resolving Psychological Stress) to administer threat-related ABM training to people with symptoms of PTSD and have tested it in a laboratory-based pilot study of 22 people with elevated PTSD symptoms. Our 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 proposed study will expand on this prior lab-based study to test ABM training on an app entirely remotely. Our primary aim is to examine the feasibility, acceptability and usability of remotely administered app-based ABM training and to determine the efficacy of remote app-based ABM training in reducing attention bias and PTSD symptom severity. Our secondary aim is to examine whether a personalized version of ABM training results in greater attentional bias change and anxiety reduction compared to a non-personalized ABM training.

Eligibility criteria: Inclusion Criteria:

* Must own an iOS device compatible with the app (i.e. iPhones or iPod Touches)
* Must score at or above 33 on PTSD Checklist (PCL-5), which indicates clinically significant PTSD symptoms.

Exclusion Criteria:

* Active suicidal ideation.

Primary outcomes:
measure: Acceptability, feasibility and usability of completing attention bias modification via a mobile app.
timeFrame: Two weeks
measure: Reduction in post traumatic stress disorder (PTSD) symptoms
timeFrame: Two weeks
Secondary outcomes:
measure: Reduction of PTSD Checklist (PCL) score with personalized attention bias modification
timeFrame: Two weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Aoife S O'Donovan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: