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AddictionNCT03826966

Comprehensive CBT (Cognitive Behavioral Therapy) Via reSET App

A study testing reSET in people with Addiction and Opioid-use Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Addiction, Opioid-use Disorder
What is being tested?
reSET
Type of treatment
Medical device
How many people
15 participants
Where
1 siteUnited States
Study dates
4 Mar 2019to 31 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Starting outpatient treatment for OUD within the PACMAT Hub and Spoke system (either the Hub or one of the Spokes)
  • Planning maintenance treatment with buprenorphine
  • Willing to participate in the study
  • Can read, write and comprehend English

Who cannot join

  • Planning an outpatient detoxification, or treatment other than buprenorphine maintenance (e.g. methadone maintenance, Vivitrol, or counseling with no medication)
  • Judged by the evaluating physician or allied clinician to need a higher level of care (e.g. residential or inpatient treatment)
  • Unwilling to participate in the study
  • Under the age of 18
  • Unable to read, write and comprehend English

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pennsylvania Psychiatric Institute, Opioid Treatment Program

    Harrisburg, Pennsylvania, 17110

Other trials in United States

About this study

Official title: Comprehensive CBT (Cognitive Behavioral Therapy) Via Reset for a Hub and Spoke MAT (Medication Assisted Treatment) System of Care

This research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system.

Being tested
reSET
Medical subject headings
Behavior, Addictive, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reSETDevice

    reSET is a mobile app created by Pear Therapeutics, Inc., which has previously been approved by the FDA.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention in treatment on MAT for 6 months after enrolling in the study

    ReSET is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). This pilot trial is evaluating the acceptability and feasibility of the app, reSET. 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.

    Measured: 6 months

Secondary outcomes (12)
  1. Opioid and other substance abuse as assessed through biological specimen

    Part of this study is looking at the effect of reSET 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.

    Measured: 6 months

  2. Opioid and other substance abuse as assessed through participant self-report

    Part of this study is looking at the effect of reSET 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.

    Measured: 6 months

  3. Cravings to use drugs as assessed by the reSET app

    Part of this study is looking at the effect of reSET on 6 month adherence and mediation of improvements in quality of life outcomes such as cravings to use drugs. This is captured in the reSET app as part of the programmed surveys that participants are asked to complete once pinged by the app. These surveys utilize a likert scale to ask the participant if they have experienced any cravings and the severity of said cravings (1 = mild cravings; 4=severe cravings). These ratings will assess total number of cravings and severity of cravings for the duration of the study (24 weeks) or up until the participant stops using the app; whichever comes first.

    Measured: 6 months

  4. 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 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). The K-10 is a 10 item questionnaire that yields a global measure of distress based on questions about anxiety and depressive symptoms that an individual has experience within the most recent four week period. The questionnaire uses a likert scale for each prompt; 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.

    Measured: 6 months

  5. Mental health symptoms specific to depression as assessed by the PHQ-9

    Part of this study is looking at the effect of reSET 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.

    Measured: 6 months

  6. Mental health symptoms related to PTSD as assessed by the PCL-C

    Part of this study is looking at the effect of reSET 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.

    Measured: 6 months

  7. Health status as assessed by the EuroQol

    Part of this study is looking at the effect of reSET on 6 month adherence and mediation of improvements in quality of life outcomes such as health status as measured by the participant self-report on the EuroQol (EQ-5D-5L). The EQ-5D-5L is a 5 item questionnaire that assesses five separate subscales including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each subscale is rated on a 1-5 likert scale (1 =no problems; 5= extremely severe problem). Data will be combined into two categories consisting of "no problem" (scores of 0) and "problems" (scores 2-5) to establish frequency counts of health status for the duration of the study.

    Measured: 6 months

  8. Coping strategies as assessed by the CSS

    Part of this study is looking at the effect of reSET on 6 month adherence and mediation of improvements in quality of life outcomes such as coping strategies as measured by the participant self-report on the Coping Strategies Scale (CSS). The CSS is 24 item questionnaire that assesses individual coping skill use on a likert scale ranging from 1-4 (1 = never use the identified coping skill; 4 = frequently use identified coping skill). A total score will be derived by taking the average of all 24 items.

    Measured: 6 months

  9. Social Connectedness as assessed by the SCS

    Part of this study is looking at the effect of reSET on 6 month adherence and mediation of improvements in quality of life outcomes such as social functioning as measured by the participant self-report on the Social Connectedness Scale (SCS). The SCS is a 20 item questionnaire that assesses psychological belonging or interpersonal closeness using a likert scale ranging from 1 to 6 (1= strongly disagree; 6 = strongly agree. A total average across all items and higher scores indicate optimal functioning and a strong sense of belongingness, while lower scores reflect a lack of strong sense of belongingness.

    Measured: 6 months

  10. HIV Risk as assessed by the SERBAS

    Part of this study is looking at the effect of reSET on 6 month adherence and mediation of improvements in quality of life outcomes such as sexual health as measured by the HIV Risk Assessment (Sexual Experience and Risk Behavior Assessment - SERBAS). The SERBAS elicits counts of protected and unprotected vaginal or anal sex occasions by partner type.

    Measured: 6 months

  11. Satisfaction of using reSET as a form of treatment as measured by a qualitative interview

    This study will also be measuring patient satisfaction with the reSET app. This will be measured by an investigator created qualitative interview assessing the patient's likes, dislikes, and ease of use with the app, as well as open ended questions regarding how the patient would improve the app. This data will be uploaded into a qualitative system such as Nvivo for analysis.

    Measured: 6 months

  12. Effectiveness of the reSET app content as measured by the IAFF

    This study will also measure the effectiveness of the reSET app from the participant's stand point. This will be measured using The Intervention Acceptability/ Feedback Form (IAFF). The IAFF is a 9 item questionnaire. Seven questions evaluate the content of the app through the use of a likert scale ranging from 0 to 10 where 0 indicates the lowest effectiveness of the content and 10 indicates highest effectiveness of the content (i.e.: usefulness, relevancy, interesting, novelty, ease of understanding, and satisfaction as related to the app content). Two open ended questions allow the participant to address additional likes and dislikes with the content, as well as suggestions on improving the content. Frequency counts will be used to analyze likert scale scores, while responses to open ended questions will be uploaded into a qualitative system such as Nvivo for analysis.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2019
  2. Study start4 Mar 2019
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03826966
Sponsor's protocol ID
00009931
Status last verified
Jul 2020
First submitted
11 Jan 2019
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing reSET in people with Addiction and Opioid-use Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention in treatment on MAT for 6 months after enrolling in the study (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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