Remotely Resolving Psychological Stress (Remote RePS)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Non-Personalized Attention Bias Training; Behavioral: Neutral Attention Training Condition; Behavioral: Personalized Attention Bias Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03196999

17-22529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 528 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

528 participants in 3 patient groups, including a placebo group

Personalized Attention Bias Training

Active Comparator group

Description:

Personalized version of ABM Training.

Treatment:

Behavioral: Personalized Attention Bias Training

Neutral Attention Training Condition

Placebo Comparator group

Description:

Non-active version of ABM training.

Treatment:

Behavioral: Neutral Attention Training Condition

Non-Personalized Attention Bias Training

Active Comparator group

Description:

Non-personalized version of ABM training.

Treatment:

Behavioral: Non-Personalized Attention Bias Training