Trial Outcomes & Findings for reSET-O RCT (Randomized Controlled Trial) (NCT NCT04129580)

Last Updated: 2024-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

6 months

Results posted on

2024-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	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,	TAU Only Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Overall Study STARTED	48	52
Overall Study COMPLETED	34	27
Overall Study NOT COMPLETED	14	25

Reasons for withdrawal

Reasons for withdrawal
Measure	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,	TAU Only Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Overall Study Lost to Follow-up	14	25

Baseline Characteristics

reSET-O RCT (Randomized Controlled Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 Participants 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,	TAU Only n=52 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).	Total n=100 Participants Total of all reporting groups
Region of Enrollment United States	48 participants n=5 Participants	52 participants n=7 Participants	100 participants n=5 Participants
Age, Continuous	37.2 years STANDARD_DEVIATION 8.7 • n=5 Participants	36.1 years STANDARD_DEVIATION 9.6 • n=7 Participants	36.6 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	46 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 Participants 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,	TAU Only n=52 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Retention in Treatment on MAT for 6 Months After Enrolling in the Study	34 Participants	27 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 Participants 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,	TAU Only n=52 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Opioid and Other Substance Abuse as Assessed Through Biological Specimen	32 Participants	33 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Treatment-As-Usual (TAU) + reSET-O n=34 Participants 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,	TAU Only n=27 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Opioid and Other Substance Abuse as Assessed Through Participant Self-report	23 Participants	17 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 Participants 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,	TAU Only n=52 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10	-4.23 units on a scale Interval -7.12 to -1.35	-4.66 units on a scale Interval -7.06 to -2.26

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 Participants 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,	TAU Only n=52 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9	-2.93 units on a scale Interval -5.02 to -0.84	-1.65 units on a scale Interval -3.4 to 0.11

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 Participants 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,	TAU Only n=52 Participants Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Mental Health Symptoms Related to PTSD as Assessed by the PCL-C	-4.71 units on a scale Interval -9.29 to -0.13	-6.60 units on a scale Interval -10.37 to -2.84

Adverse Events

Treatment-As-Usual (TAU) + reSET-O

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

TAU Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment-As-Usual (TAU) + reSET-O n=48 participants at risk 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,	TAU Only n=52 participants at risk Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O).
Injury, poisoning and procedural complications overdose	2.1% 1/48 • Number of events 1 • 6 months over the course of study enrollment per participant. The study	0.00% 0/52 • 6 months over the course of study enrollment per participant. The study

Other adverse events

Adverse event data not reported

Additional Information

Dr Sarah Kawasaki

Penn State Milton S. Hershey Medical Center

Phone: 7175311000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place