Alcohol Use Disorder, PTSD
Conditions
Brief summary
This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.
Interventions
BEHAVIORALCOPE
The COPE therapy is a talk-therapy in which individuals are asked about their trauma, alcohol use, mood, and behavior. The therapy occurs over 12 sessions and will be paired with a telehealth technology system to determine if it enhances the COPE therapy. The telehealth system is worn on the arm and hand during the out-of-office COPE homework assignments. It consists of a small camera (about the size of a pencil eraser), Bluetooth earpiece with microphone, monitors to measure and record heart rate and skin conductance, and a breathalyzer to assess blood alcohol content. The device will connect to an application on password protected cell phone that will monitor and record the above listed information as well as reported subjective units of distress and craving. A study coach will virtually guide participants through one out-of-office assignment per week using this technology. Interviews and surveys will be collected at study baseline and weekly during treatment.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female; aged 18-70 years. 2. Able to provide written informed consent. 3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder. 4. Meet DSM-5 diagnostic criteria for current PTSD. 5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
Exclusion criteria
1. Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders. 2. Current suicidal or homicidal ideation and intent. 3. Psychotropic medications which have been initiated during the past 4 weeks. 4. Acute alcohol withdrawal. 5. Pregnancy or breastfeeding for people of childbearing potential. 6. Currently enrolled in evidence based behavioral treatment for AUD or PTSD. 7. Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less | In-Session Visit (approximately 1 week from baseline) | Feasibility is 80% of participants turning on and off equipment in 5 minutes or less |
| System Usability Scale | Week 12 | The System Usability Scale measures how usable and acceptable a product is. This scale ranges from 0-100 with higher scores being indicative of greater usability/acceptability. A mean score of 68 or greater is considered acceptable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COPE Therapy Arm Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)
COPE: The COPE therapy is a talk-therapy in which individuals are asked about their trauma, alcohol use, mood, and behavior. The therapy occurs over 12 sessions and will be paired with a telehealth technology system to determine if it enhances the COPE therapy. The telehealth system is worn on the arm and hand during the out-of-office COPE homework assignments. It consists of a small camera (about the size of a pencil eraser), Bluetooth earpiece with microphone, monitors to measure and record heart rate and skin conductance, and a breathalyzer to assess blood alcohol content. The device will connect to an application on password protected cell phone that will monitor and record the above listed information as well as reported subjective units of distress and craving. A study coach will virtually guide participants through one out-of-office assignment per week using this technology. Interviews and surveys will be collected at study baseline and weekly during treatment. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | COPE Therapy Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 37.00 years STANDARD_DEVIATION 10.8 |
| Alcohol Use Disorder Identification Test | 27.67 units on a scale STANDARD_DEVIATION 12.01 |
| Clinician-Administered PTSD Scale for DSM-5 | 36.50 units on a scale STANDARD_DEVIATION 4.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent Days Drinking (Timeline Followback) | 41.23 percent of days STANDARD_DEVIATION 35.73 |
| PTSD Checklist for DSM-5 | 50.00 units on a scale STANDARD_DEVIATION 5.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
Time frame: In-Session Visit (approximately 1 week from baseline)
Population: Two enrolled participant completed this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COPE Therapy Arm | Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less | 2 Participants |
Primary
System Usability Scale
The System Usability Scale measures how usable and acceptable a product is. This scale ranges from 0-100 with higher scores being indicative of greater usability/acceptability. A mean score of 68 or greater is considered acceptable.
Time frame: Week 12
Population: Two enrolled participants completed this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COPE Therapy Arm | System Usability Scale | 90.00 units on a scale | Standard Deviation 7.07 |