Alcohol Use Disorder, Post-Traumatic Stress Disorder
Conditions
Keywords
Attention Bias Modification, PTSD, Digital Health, Alcohol Use Disorder
Brief 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 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.
Interventions
DEVICERePS (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.
DEVICERePS (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.
Sponsors
San Francisco Veterans Affairs Medical Center
United States Department of Defense
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blind to the bias modification training they are assigned.
Intervention model description
Participants will be assigned to either a threat attention bias modification training or a neutral attention training.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Must have current PTSD symptoms. 2. Must drink alcohol.
Exclusion criteria
1. Very recent or current trauma or trauma exposure. 2. Recent moderate or severe non-alcohol substance use disorder. 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, systemic illness affecting nervous system function, heart defect, or medically unstable injuries. 6. Recent or planned change in psychotherapeutic treatment for PTSD or other psychiatric symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Neutral Attention 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. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete Data | 2 | 4 |
Baseline characteristics
| Characteristic | Threat ABM Training | Neutral Attention Training | Total |
|---|---|---|---|
| Age, Continuous | 44.57 years STANDARD_DEVIATION 9.25 | 39.30 years STANDARD_DEVIATION 11.57 | 44 years STANDARD_DEVIATION 11.57 |
| PTSD Checklist-5 (PCL-5) Score | 36.07 units on a scale STANDARD_DEVIATION 17.17 | 37.62 units on a scale STANDARD_DEVIATION 20.99 | 36.81 units on a scale STANDARD_DEVIATION 18.75 |
| Race/Ethnicity, Customized African American/Black | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian/European American | 9 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one ethnicity | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
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.
Time frame: 15 days apart
Population: 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.
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.
Time frame: 15 days apart
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Threat ABM Training | PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days | Pre PCL Score | 33.2 units on a scale | Standard Deviation 16.1 |
| Threat ABM Training | PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days | Post PCL Score | 31.2 units on a scale | Standard Deviation 15.8 |
| Neutral Attention Training | PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days | Pre PCL Score | 36.6 units on a scale | Standard Deviation 20.9 |
| Neutral Attention Training | PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days | Post PCL Score | 28.2 units on a scale | Standard Deviation 21.9 |
p-value: 0.322ANOVA
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.
Time frame: 15 days
Population: Analyses included all participants that completed the usability assessment questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Threat ABM Training | 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 | Convenience | 4.02 score on a scale | Standard Deviation 1.06 |
| Threat ABM Training | 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 | Comfort with the app | 4.44 score on a scale | Standard Deviation 0.8 |
| Threat ABM Training | 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 | Enjoyable | 3.29 score on a scale | Standard Deviation 1.13 |
| Threat ABM Training | 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 | Overall satisfaction | 4.17 score on a scale | Standard Deviation 0.87 |
| Threat ABM Training | 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 | Ease of use | 4.56 score on a scale | Standard Deviation 0.74 |
| Neutral Attention Training | 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 | Overall satisfaction | 4.05 score on a scale | Standard Deviation 1.02 |
| Neutral Attention Training | 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 | Ease of use | 4.52 score on a scale | Standard Deviation 0.9 |
| Neutral Attention Training | 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 | Convenience | 3.92 score on a scale | Standard Deviation 1.16 |
| Neutral Attention Training | 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 | Enjoyable | 3.18 score on a scale | Standard Deviation 1.22 |
| Neutral Attention Training | 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 | Comfort with the app | 4.41 score on a scale | Standard Deviation 0.83 |