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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPE Therapy Arm | Experimental | Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | In-Session Visit (approximately 1 week from baseline) |
| 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amber M Jarnecke, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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, Categorical | Count of Participants |
| 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 | 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 | Two enrolled participant completed this assessment. | Posted | Count of Participants | Participants | In-Session Visit (approximately 1 week from baseline) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold | Infections and infestations | Systematic Assessment | Common cold symptoms - found unrelated to intervention and study procedures |
Limitations from this pilot trial include the small sample size, that some participants dropped out from the study without completing the full course of study treatment, and that not all participants were able (either due to study dropout or due to technological equipment failure) to complete all primary outcome assessments. As such, results should be interpreted with these limitations in mind.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amber Jarnecke | Medical University of South Carolina | 843-876-3115 | jarnecka@musc.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 | Apr 19, 2022 | Nov 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2021 | Apr 26, 2024 | ICF_001.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 |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinician-Administered PTSD Scale for DSM-5 | The Clinician-Administered PTSD Scale for DSM-5 is a structured interview assessment of PTSD symptoms over the past month. Scale ranges from 0-80, such that higher scores are indicative of greater PTSD symptom severity. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist for DSM-5 | PTSD Checklist for DSM-5 is a self-report measure of PTSD symptoms over the past week. Scale ranges from 0-80, such that higher scores are indicative of greater PTSD symptom severity. This scale has a suggested cutoff score of 31-33 for a provisional diagnosis of PTSD. | One participant did not complete this measure at baseline | Mean | Standard Deviation | units on a scale |
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| Percent Days Drinking (Timeline Followback) | Percent days drinking was assessed via a 60-day Timeline Followback assessment. Higher values are indicative of a greater percentage of drinking days in the 60 prior to the assessment. | Mean | Standard Deviation | percent of days |
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| Alcohol Use Disorder Identification Test | The Alcohol Use Disorder Identification Test is a self-report measure of alcohol use problems over past year. Scale ranges from 0-40, such that higher scores are indicative of more alcohol use problems. Scores in the 0-7 indicate low-risk consumption, scores in the 8-14 range indicate hazardous or harmful alcohol consumption, and scores at 15 or greater indicate likelihood of moderate-to-severe alcohol use disorder. | One participant did not complete this measure at baseline | Mean | Standard Deviation | units on a scale |
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| 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. | Two enrolled participants completed this assessment. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| 4 |
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| Stomach bug | Infections and infestations | Systematic Assessment | Stomach bug symptoms - found unrelated to intervention and study procedures |
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| COVID-19 | Infections and infestations | Systematic Assessment | COVID-19 infection - found unrelated to intervention and study procedures |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |