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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Pear Therapeutics, Inc. | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| Research Foundation for Mental Hygiene, Inc. |
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This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.
This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-As-Usual (TAU) + reSET-O | Experimental | Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O. |
|
| TAU only | No Intervention | Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reSET-O app | Device | The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse, |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Treatment on MAT for 6 Months After Enrolling in the Study | reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid and Other Substance Abuse as Assessed Through Biological Specimen | Part of this study is looking at the effect of reSET-O on substance use. This will be measured by collecting urine drug screens to assess drug use (if any) at each research appointment. The number of endorsed drugs used (as indicated by a positive urine drug screen) will be counted and recorded for each research visit. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Psychiatric Institute | Harrisburg | Pennsylvania | 17110 | United States |
Penn State's opioid use disorder clinic (opioid treatment program; OTP), housed at the Pennsylvania Psychiatric Institute will be housing and collecting all data. App data transfers will come from Pear Therapeutics, Inc. to the Penn State study team. This data will not include identifiable information. This data will include the number of modules completed per participant, as well as survey data (as assessed by the app) related to cravings and use. Data will be shared using a Penn State IT approved interface such as Kite Drive, Accelion, or File Drop. Penn State will in turn share data with Columbia University research team (collaborators on the study), for data analyses. Again, this data will be deidentified and will be shared via a Penn State IT approved system as mentioned above.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-As-Usual (TAU) + reSET-O | Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O. reSET-O app: The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse, |
| FG001 | TAU Only | Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-As-Usual (TAU) + reSET-O | Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O. reSET-O app: The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse, |
| 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 | Retention in Treatment on MAT for 6 Months After Enrolling in the Study | reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention. | Posted | Count of Participants | Participants | 6 months |
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6 months over the course of study enrollment per participant.
The study
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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 | Treatment-As-Usual (TAU) + reSET-O | Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O. reSET-O app: The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse, |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| overdose | Injury, poisoning and procedural complications | Non-systematic Assessment | shortly after randomization, patient used funds from study to purchase OTC medications, which he then ingested. He was treated at the local hospital for nonfatal overdose, and he withdrew from both treatment and the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarah Kawasaki | Penn State Milton S. Hershey Medical Center | 7175311000 | skawasaki@pennstatehealth.psu.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 | Mar 26, 2024 | Apr 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2022 | Apr 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OTHER |
Single site, randomized controlled trial research study.
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|
| Opioid and Other Substance Abuse as Assessed Through Participant Self-report | Part of this study is looking at the effect of reSET-o on substance use. This will be measured by participant self-report on the Timeline Follow Back Questionnaire (TLFB). The TLFB is a self-report measure that gages the participant's memory by using a calendar to assess drug use within a specific period of time. The number of endorsed drugs used (as indicated by the participant) will be counted and recorded for each research visit. | 6 months |
| Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10 | Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as overall mental health symptoms as measured by participant self-report on the Kessler 10 (K-10). A score of one indicates that an individual experiences symptoms or issues "None of the time," whereas a score of five indicates that an individual experiences symptoms or issues "All of time." The scores are summed and total amounts will fall in one of four categories: Score under 20 = likely to be well; Score 20-24 = likely to have a mild mental disorder; Score 25-29 = likely to have a moderate mental disorder; and Score 30 or more = likely to have a severe mental disorder. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study. | 6 months |
| Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9 | Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to depression as measured by the participant self-report on the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire that assesses depressive symptoms or issues using a likert scale from "0 to 3;" 0 indicating no symptoms or issues and 3 indicating symptoms or issues occurring nearly every day. Scores are summed to calculate a total score. Scores 1-4 indicated minimal depression; scores 5-9 indicate mild depression; scores 10-14 indicate moderate depression; scores 15-19 indicated moderately severe depression; and scores 20-27 indicate severe depression. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study. | 6 months |
| Mental Health Symptoms Related to PTSD as Assessed by the PCL-C | Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to post-traumatic stress disorder as measured by the participant self-report on the abbreviated PTSD Checklist-Civilian Version (PCL-C). The PCL-C is a 17 item questionnaire that assesses PTSD symptoms on a likert scale from one to five (one = no symptoms or issues; five = extreme symptoms or issues). The scores are summed and a score of 30 or more indicates clinical PTSD symptoms. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study. | 6 months |
| BG001 | TAU Only | Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | TAU Only | Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). |
|
|
| Secondary | Opioid and Other Substance Abuse as Assessed Through Biological Specimen | Part of this study is looking at the effect of reSET-O on substance use. This will be measured by collecting urine drug screens to assess drug use (if any) at each research appointment. The number of endorsed drugs used (as indicated by a positive urine drug screen) will be counted and recorded for each research visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Opioid and Other Substance Abuse as Assessed Through Participant Self-report | Part of this study is looking at the effect of reSET-o on substance use. This will be measured by participant self-report on the Timeline Follow Back Questionnaire (TLFB). The TLFB is a self-report measure that gages the participant's memory by using a calendar to assess drug use within a specific period of time. The number of endorsed drugs used (as indicated by the participant) will be counted and recorded for each research visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10 | Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as overall mental health symptoms as measured by participant self-report on the Kessler 10 (K-10). A score of one indicates that an individual experiences symptoms or issues "None of the time," whereas a score of five indicates that an individual experiences symptoms or issues "All of time." The scores are summed and total amounts will fall in one of four categories: Score under 20 = likely to be well; Score 20-24 = likely to have a mild mental disorder; Score 25-29 = likely to have a moderate mental disorder; and Score 30 or more = likely to have a severe mental disorder. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
|
| Secondary | Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9 | Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to depression as measured by the participant self-report on the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire that assesses depressive symptoms or issues using a likert scale from "0 to 3;" 0 indicating no symptoms or issues and 3 indicating symptoms or issues occurring nearly every day. Scores are summed to calculate a total score. Scores 1-4 indicated minimal depression; scores 5-9 indicate mild depression; scores 10-14 indicate moderate depression; scores 15-19 indicated moderately severe depression; and scores 20-27 indicate severe depression. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
|
| Secondary | Mental Health Symptoms Related to PTSD as Assessed by the PCL-C | Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to post-traumatic stress disorder as measured by the participant self-report on the abbreviated PTSD Checklist-Civilian Version (PCL-C). The PCL-C is a 17 item questionnaire that assesses PTSD symptoms on a likert scale from one to five (one = no symptoms or issues; five = extreme symptoms or issues). The scores are summed and a score of 30 or more indicates clinical PTSD symptoms. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
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|
| 0 |
| 48 |
| 1 |
| 48 |
| 0 |
| 48 |
| EG001 | TAU Only | Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). | 0 | 52 | 0 | 52 | 0 | 52 |
|
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