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| Name | Class |
|---|---|
| San Francisco Veterans Affairs Medical Center | FED |
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Threat ABM Training | Active Comparator | Attention Bias Modification Training with threatening words |
|
| Neutral Attention Training | Placebo Comparator | Non-active version of ABM Training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RePS (Resolving Psychological Stress) - Threat ABM Training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 15 days apart |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aoife S O'Donovan, Ph.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aoife O'Donovan | San Francisco | California | 94121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Threat ABM Training | Attention Bias Modification Training with threatening words RePS (Resolving Psychological Stress) - 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. |
| FG001 | Neutral Attention Training | Non-active version of ABM Training RePS (Resolving Psychological Stress) - 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analyses of baseline characteristics have been conducted on the 28 participants that enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Threat ABM Training | All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received. |
| BG001 | Neutral Attention Training |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants used in analyses completed at least 16/20 items of the PCL-5 (total 20 items) on both Day 1 (Pre) and Day 15 (Post). | Posted | Mean | Standard Deviation | units on a scale | 15 days apart |
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Adverse events were monitored for the duration of participation which lasted eight weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Threat ABM Training | Attention Bias Modification Training with threatening words RePS (Resolving Psychological Stress) - 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. |
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Sample size is limited and results should be interpreted cautiously.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aoife O'Donovan, Associate Professor of Psychiatry | University of California, San Francisco | 4152214810 | x24959 | aoife.odonovan@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2020 | Aug 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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Participants will be assigned to either a threat attention bias modification training or a neutral attention training.
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Participants will be blind to the bias modification training they are assigned.
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| RePS (Resolving Psychological Stress) - Neutral Attention Training | Device | 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. |
|
| 15 days |
All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PTSD Checklist-5 (PCL-5) Score | The PCL-5 assesses the presence and severity of 20 different symptoms posttraumatic stress disorder (PTSD). Each of the 20 items is scored on a severity range of 0 (not at all) to 4 (extremely), for a final score range of 0-80. A score of 33 and above is indicative of clinically significant PTSD symptoms. Higher scores indicate worse PTSD symptom severity. | 1 participant did not complete the PCL at baseline. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Neutral Attention Training | Non-active version of ABM Training RePS (Resolving Psychological Stress) - 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. |
|
|
|
| Primary | 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. | Due to technical difficulties, we were unable to calculate heart rate variability for the participants in this study. Thus, HRV data was not collected in this study. | Posted | 15 days apart |
|
|
| Secondary | 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. | Analyses included all participants that completed the usability assessment questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 15 days |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Neutral Attention Training | Non-active version of ABM Training RePS (Resolving Psychological Stress) - 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Enjoyable |
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| Comfort with the app |
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| Overall satisfaction |
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