Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder
Phase: NA
Conditions: Post-Traumatic Stress Disorder, Alcohol Use Disorder
Sponsor: University of California, San Francisco

 
 
 
 
 
 
Resolving Psychological Stress 
 
University of San Francisco, California 
San Francisco Veteran’s Affairs Health Care System 
 
 
 
Principal Investigator: Aoife O’Donovan, PhD 
 
NCT03996876 
 
Document Date: 9/11/2020 
 
 

Study Protocol 
Overview: 
We will perform a phone screen or have participants fill out an online eligibilty survey to 
determine eligibility for the study. Based on the answers to the screening questions, we 
will invite potentially eligible participants to attend an appointment at the San Francisco 
Veterans Affairs Medical Center to complete baseline assessments to include eligibility 
assessments and baseline testing. We may ask the questions from the eligibility 
screening in person if this is requested by the interested potential participant.  The 
eligibility assessment will include the Clinician Administered PTSD Scale and the 
Structured Clinical Interview for the American Psychiatric Association's Diagnostic and 
Statistical Manual-V. For participants who are eligible after these assessments, we will 
complete baseline testing, which will include psychological and physiological tests. The 
eligibility and baseline assessments can take place over the course of one or two 
appointments. Following this, participants will be instructed on how to use the mobile 
app and how to complete the 15 days of training and assessments. Finally, after 
completing this program of training and assessments, they will return to the lab for 
follow-up assessments. 
   
Inclusion Criteria: 
To qualify for participation, participants will: 1) have current chronic PTSD (full- or sub-
threshold) as defined by DSM-V criteria lasting at least 3 months and meeting at least 
one DSM-V criteria for threat sensitivity; 2) be aged 18-75; 3) have the ability to 
understand and comply with the training protocol and complete study assessments; 4) 
be either veterans or non-veterans; 5) have a DSM-V diagnosis of Alcohol Use 
Disorder. 
 
Exclusion Criteria: 
Exclusionary criteria include: 1) current ongoing trauma or trauma exposure within the 
past 3 months; 2) severe non-alcohol substance use disorder in the past 3 months (any 
level of alcohol use disorder is acceptable); 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 (e.g., loss of consciousness 
greater than 30 minutes, severe traumatic brain injury), systemic illness affecting 
nervous system function, heart defect, or medically unstable injuries; 6) Recent change 
in psychotherapeutic treatment (e.g., psychotherapy, counseling) for PTSD or other 
psychiatric symptoms within the last 3 months, change in type of pharmacological 
treatment or a greater than 50% change in dose of pharmacological treatment within the 
last 3 months, or a planned change under one of these categories during the study 
period*; 7) subjects who, in the opinion of the investigator, are otherwise unsuitable for 
a study of this type. Individuals who are determined to require additional services, 
whether included or excluded from the study, will be referred to the VA or outside 
services if clinically appropriate. Additionally, individuals who report significant hearing 
difficulties but who are deemed eligible to participate in the study otherwise will be 
excluded from the fear-potentiated startle portion of the assessments at baseline and 
follow-up, as this task involves an acoustic startle. 
  

15-Day Training and Assessment Phase: 
The 15-day training and assessment phase will take place with the assistance of a 
mobile application called REPS (Resolving Psychological Stress). Eligible consenting 
participants will perform REPS training and assessments on the mobile application for 
15 days. Participants will have up to three weeks to complete all the sessions. 
Participants will be instructed to complete a total of twelve days of training in 
conjunction with daily assessments of mood, stress, sleep and unusual events as well 
as three days of a more thorough assessment of mood, stress, depression, anxiety and 
PTSD symptoms once per week on the device.  The training days involve approximately 
15-minute long sessions of the REPS paradigm dot probe training and daily questions 
on the mobile app. Weekly assessment days should take 20 minutes on the mobile app. 
Participants may contact study personnel during office hours with questions or concerns 
via telephone or through email.  We will contact participants by phone once per week to 
assess adherence to the protocol and to ensure that their device is functioning properly. 
We will assess adherence only by self-report. App-based follow-up assessments will 
take place at the end of 12 days of training. For participants who have not completed 12 
days of training within 21 days of the start of training, we will push a follow-up 
assessment, which they will be asked to complete as soon as possible. 
  
REPS Paradigm 
Each training session with daily questions will last for approximately 15 minutes. At the 
beginning of the session, participants will be asked to report on their mood and 
emotions and stress exposure before beginning the REPS training session. During the 
training session, they will be exposed to threatening words in the ABM condition (e.g., 
death, crazy, worry) or neutral words in the control condition (e.g. hill, jersey, check). 
These are chosen based on their own ratings of 50 words. The ratings are entered into 
an algorithm which determines the most threatening words for that participant. On each 
trial, the participants will be exposed to a threatening (ABM) or neutral (control) word 
and a matched neutral word for a very brief period of time (500ms). The words will then 
disappear and one of them will be replaced by a probe in the form of either the letter E 
or F and the participant will be asked to indicate whether an E or an F appears. In the 
ABM training paradigm, the probe will replace the neutral stimulus all of the time, which 
is thought to train the participants to direct their attention towards a neutral stimulus in 
the context of a threatening stimulus. In the control condition, the probe will replace one 
set of neutral stimuli all of the time. There will be a brief inter-trial break (e.g., 500 - 1500 
ms) between each trial. The participant will complete this training task for last 
approximately 10 minutes with an additional 5 minutes of daily questions. 
  
 
 
 
 
 
 
 
 

Statistical Analysis Plan 
 
Power analysis: This study is designed to yield estimates of effect size rather than to 
complete a definitive trial of ABM in PTSD. 
 
Statistical Analyses: Descriptive analyses of behavioral and questionnaire data are used 
to assess feasibility and acceptability of REPS. Exploratory analyses examine the 
effects of intervention (attention bias modification versus control training) x time 
(baseline, follow up) on PCL-5 (PTSD Checklist-5) scores using mixed models. The 
PCL-5 was given via the mobile application immediately before participants starting their 
threat-related attention bias or neutral control attention training and at follow-up.