Post-Traumatic Stress DisorderRePSNCT03996876
Resolving Psychological Stress
A study testing RePS (Resolving Psychological Stress) - Threat ABM Training and RePS (Resolving Psychological Stress) - Neutral Attention Training in people with Post-Traumatic Stress Disorder and Alcohol Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Alcohol Use Disorder
- What is being tested?
- RePS (Resolving Psychological Stress) - Threat ABM Training and RePS (Resolving Psychological Stress) - Neutral Attention Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 16 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have current PTSD symptoms.
- Must drink alcohol.
Who cannot join
- Very recent or current trauma or trauma exposure.
- Recent moderate or severe non-alcohol substance use disorder.
- Active suicidality.
- Lifetime history of schizophrenia or bipolar disorder I.
- Medical conditions including seizure disorders, neurological disorders, moderate or severe head injury, systemic illness affecting nervous system function, heart defect, or medically unstable injuries.
- Recent or planned change in psychotherapeutic treatment for PTSD or other psychiatric symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder
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.
Read the 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.
- Being tested
- RePS (Resolving Psychological Stress) - Threat ABM Training, RePS (Resolving Psychological Stress) - Neutral Attention Training
- Keywords
- Attention Bias Modification, PTSD, Digital Health, Alcohol Use Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RePS (Resolving Psychological Stress) - Threat ABM TrainingDevice
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.
RePS (Resolving Psychological Stress) - Neutral Attention TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Threat ABM Training | Active comparator | Attention Bias Modification Training with threatening words Receives: Device: RePS (Resolving Psychological Stress) - Threat ABM Training |
| Neutral Attention Training | Placebo comparator | Non-active version of ABM Training Receives: Device: RePS (Resolving Psychological Stress) - Neutral Attention Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days
The PTSD Checklist-5 (PCL- 5) was administered via the mobile application to assess changes in PTSD symptoms. The PCL-5 is a well validated and widely used structured 20-item diagnostic interview for assessing symptomology of PTSD corresponding to a DSM-5 diagnosis. PCL scores range from 0-80, with a score of 33 or above indicating clinically significant PTSD symptoms. Participants were asked about the severity of symptoms over the past week.
Measured: 15 days apart
Differences in Heart Rate Variability (HRV) During a Threat Sensitivity Computerized Task
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.
Measured: 15 days apart
Secondary outcomes (1)
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days
A usability assessment questionnaire was administered with multiple feasibility and acceptability questions regarding the REPS Mobile Application (Ease of use, Convenience, Enjoyment, Comfort with the app and Overall satisfaction). The responses were measured on a Five-Point Scale with 1 meaning "Not at all" and 5 meaning "Very much"." Analyses included all participants that completed the usability assessment questionnaire.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start9 Jan 2018
- Primary completion30 Jun 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either a threat attention bias modification training or a neutral attention training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Aoife S O'Donovan, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996876
- Sponsor's protocol ID
- 12-10411
- Acronym
- RePS
- Status last verified
- Nov 2021
- First submitted
- 30 Apr 2018
- Last updated
- 7 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolving Psychological Stress (RePS): a Mobile Health Application for Modifying Attention Bias to Threat in Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03996876
- Acronym / sponsor ID
- RePS / 12-10411
- Keywords
- Attention Bias Modification, PTSD, Digital Health, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, United States Department of Defense
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be assigned to either a threat attention bias modification training or a neutral attention training.
| Arm | Type | Receives |
|---|---|---|
| Threat ABM Training | Active comparator | Device: RePS (Resolving Psychological Stress) - Threat ABM TrainingAttention Bias Modification Training with threatening words |
| Neutral Attention Training | Placebo comparator | Device: RePS (Resolving Psychological Stress) - Neutral Attention TrainingNon-active version of ABM Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have current PTSD symptoms.
- Must drink alcohol.
Key exclusion criteria (6 listed)
- Very recent or current trauma or trauma exposure.
- Recent moderate or severe non-alcohol substance use disorder.
- Active suicidality.
- Lifetime history of schizophrenia or bipolar disorder I.
- Medical conditions including seizure disorders, neurological disorders, moderate or severe head injury, systemic illness affecting nervous system function, heart defect, or medically unstable injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RePS (Resolving Psychological Stress) - Threat ABM TrainingThis 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. | Device | Threat ABM Training |
| RePS (Resolving Psychological Stress) - Neutral Attention TrainingThis app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words. | Device | Neutral Attention Training |
Primary outcome
PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days
Time frame: 15 days apart
The PTSD Checklist-5 (PCL- 5) was administered via the mobile application to assess changes in PTSD symptoms. The PCL-5 is a well validated and widely used structured 20-item diagnostic interview for assessing symptomology of PTSD corresponding to a DSM-5 diagnosis. PCL scores range from 0-80, with a score of 33 or above indicating clinically significant PTSD symptoms. Participants were asked about the severity of symptoms over the past week.
Differences in Heart Rate Variability (HRV) During a Threat Sensitivity Computerized Task
Time frame: 15 days apart
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.
1 secondary outcome
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aoife S O'Donovan, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RePS (Resolving Psychological Stress) - Threat ABM Training and RePS (Resolving Psychological Stress) - Neutral Attention Training in people with Post-Traumatic Stress Disorder and Alcohol Use Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days (time frame: 15 days apart). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021; AzTrials last refreshed its copy on 27 Oct 2026.