Trial Outcomes & Findings for BioWare for AUD and PTSD (NCT NCT05187364)
NCT ID: NCT05187364
Last Updated: 2024-09-24
Results Overview
Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
In-Session Visit (approximately 1 week from baseline)
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not complete this measure at baseline
Baseline characteristics by cohort
| Measure |
COPE Therapy Arm
n=4 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
37.00 years
STANDARD_DEVIATION 10.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
|
Clinician-Administered PTSD Scale for DSM-5
|
36.50 units on a scale
STANDARD_DEVIATION 4.51 • n=4 Participants
|
|
PTSD Checklist for DSM-5
|
50.00 units on a scale
STANDARD_DEVIATION 5.57 • n=3 Participants • One participant did not complete this measure at baseline
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|
Percent Days Drinking (Timeline Followback)
|
41.23 percent of days
STANDARD_DEVIATION 35.73 • n=4 Participants
|
|
Alcohol Use Disorder Identification Test
|
27.67 units on a scale
STANDARD_DEVIATION 12.01 • n=3 Participants • One participant did not complete this measure at baseline
|
PRIMARY outcome
Timeframe: In-Session Visit (approximately 1 week from baseline)Population: Two enrolled participant completed this assessment.
Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
Outcome measures
| Measure |
COPE Therapy Arm
n=2 Participants
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.
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|---|---|
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Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Two enrolled participants completed this assessment.
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.
Outcome measures
| Measure |
COPE Therapy Arm
n=2 Participants
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.
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|---|---|
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System Usability Scale
|
90.00 units on a scale
Standard Deviation 7.07
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Adverse Events
COPE Therapy Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
COPE Therapy Arm
n=4 participants at risk
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.
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|---|---|
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Infections and infestations
Common Cold
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for each participant over the course of their COPE therapy treatment (i.e., up to 12 session that could take place over 6 months).
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|
Infections and infestations
Stomach bug
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for each participant over the course of their COPE therapy treatment (i.e., up to 12 session that could take place over 6 months).
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|
Infections and infestations
COVID-19
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for each participant over the course of their COPE therapy treatment (i.e., up to 12 session that could take place over 6 months).
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Additional Information
Dr. Amber Jarnecke
Medical University of South Carolina
Phone: 843-876-3115
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place