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Disclosure Intervention for People in Recovery From Opioid Use Disorder

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Disclosing Recovery: A Decision Aid and Toolkit
Mindfulness
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid-use Disorder focused on measuring disclosure, social support, stigma, patient decision aid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • currently receiving outpatient treatment at the recruitment site
  • are considering disclosing their recovery status to at least one person in the next month
  • have access to a phone that can receive text messages and phone calls

Exclusion Criteria:

  • current diagnosis of severe mental illness

Sites / Locations

  • Brandywine Counseling and Community Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Disclosure Intervention Arm

Control Arm

Arm Description

Participants will be guided through a workbook and accompanying worksheet designed to help them: (1) decide whether or not they want to share information about their substance use with others, and (2) build skills for disclosing (e.g., planning what to say). Importantly, the intervention is not designed to encourage participants to disclose or not disclose, but rather to help participants decide whether they want to disclose based on their own goals and values.

Participants will be able to choose from several guided meditations to promote mindfulness.

Outcomes

Primary Outcome Measures

Acceptability of Intervention
Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017)
Feasibility of Intervention
Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017)
Decision Making Quality
Measured informed by recommendations for evaluating patient decision aids (Sepucha et al., 2013), decisional conflict scale (O'Conner, 1995), and involvement in decision making (Lerman et al., 1990)

Secondary Outcome Measures

Social Support
Measure adapted from Medical Outcomes Study Social Support Survey (Moser et al., 2012); Scores range 1-5, higher scores indicate more social support
Enacted Stigma
Measure adapted from Methadone Maintenance Treatment Stigma Mechanisms Scale (Smith et al., 2019); Scores range 1-5, higher scores indicate greater stigma
Commitment to Sobriety
Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Scores range 1-6, higher scores indicate greater commitment to sobriety

Full Information

First Posted
April 2, 2021
Last Updated
November 14, 2022
Sponsor
University of Delaware
Collaborators
National Institute on Drug Abuse (NIDA), Massachusetts General Hospital, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT04836247
Brief Title
Disclosure Intervention for People in Recovery From Opioid Use Disorder
Official Title
Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
National Institute on Drug Abuse (NIDA), Massachusetts General Hospital, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many people with substance use disorders struggle with decisions regarding whether to disclose to others that they have a history of substance use and/or are in recovery. Yet, these decisions are important because disclosures can lead to reactions from others that harm or help recovery. For example, stigmatizing responses can harm the mental health of people in recovery whereas supportive responses can strengthen people's commitment to their sobriety. We have developed a brief intervention to help people decide whether and how to tell others about their recovery as well as build skills for disclosure. The purpose of this study is to pilot test this intervention and test its acceptability and feasibility as well as determine if it shows preliminary signs of efficacy in comparison to a control condition. We hypothesize that: (1) participants exposed to the intervention condition will agree that the intervention is acceptable and feasible, and (2) participants in the intervention condition will report higher quality decision making in comparison to participants in the control condition.
Detailed Description
Data will be collected from participants at two time points, spaced one month apart. All participants will be recruited from the waiting room at a local treatment center. The research assistant will screen interested individuals for eligibility in person and schedule study appointments, which may be coordinated with treatment appointments. All study screening and appointments will be conducted in private spaces at the treatment center. At the first study appointment, the research assistant will introduce the study, check for questions, and obtain consent for the study procedures, medical record review, and follow up procedures. Participants will be randomly assigned to receive either the disclosure intervention or a control intervention (i.e., an evidence-based mindfulness intervention). Following the intervention, participants will complete measures of acceptability, feasibility, and decision quality. At the second study appointment, participants will again be asked to respond to survey and interview questions designed to further evaluate the preliminary efficacy of the intervention. In particular, we will investigate whether participants who completed our disclosure intervention report better relationship outcomes than participants who completed the control condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
disclosure, social support, stigma, patient decision aid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Disclosure Intervention Arm
Arm Type
Experimental
Arm Description
Participants will be guided through a workbook and accompanying worksheet designed to help them: (1) decide whether or not they want to share information about their substance use with others, and (2) build skills for disclosing (e.g., planning what to say). Importantly, the intervention is not designed to encourage participants to disclose or not disclose, but rather to help participants decide whether they want to disclose based on their own goals and values.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Participants will be able to choose from several guided meditations to promote mindfulness.
Intervention Type
Behavioral
Intervention Name(s)
Disclosing Recovery: A Decision Aid and Toolkit
Intervention Description
Participants will be guided through a workbook and accompanying worksheet designed to help them: (1) decide whether or not they want to share information about their substance use with others, and (2) build skills for disclosing (e.g., planning what to say). Importantly, the intervention is not designed to encourage participants to disclose or not disclose, but rather to help participants decide whether they want to disclose based on their own goals and values.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Participants will be able to choose from several guided meditations to promote mindfulness
Primary Outcome Measure Information:
Title
Acceptability of Intervention
Description
Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017)
Time Frame
Month 0, immediately following intervention delivery
Title
Feasibility of Intervention
Description
Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017)
Time Frame
Month 0, immediately following intervention delivery
Title
Decision Making Quality
Description
Measured informed by recommendations for evaluating patient decision aids (Sepucha et al., 2013), decisional conflict scale (O'Conner, 1995), and involvement in decision making (Lerman et al., 1990)
Time Frame
Month 0, immediately following intervention delivery
Secondary Outcome Measure Information:
Title
Social Support
Description
Measure adapted from Medical Outcomes Study Social Support Survey (Moser et al., 2012); Scores range 1-5, higher scores indicate more social support
Time Frame
Month 1, at follow-up appointment
Title
Enacted Stigma
Description
Measure adapted from Methadone Maintenance Treatment Stigma Mechanisms Scale (Smith et al., 2019); Scores range 1-5, higher scores indicate greater stigma
Time Frame
Month 1, at follow-up appointment
Title
Commitment to Sobriety
Description
Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Scores range 1-6, higher scores indicate greater commitment to sobriety
Time Frame
Month 1, at follow-up appointment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older currently receiving outpatient treatment at the recruitment site are considering disclosing their recovery status to at least one person in the next month have access to a phone that can receive text messages and phone calls Exclusion Criteria: current diagnosis of severe mental illness
Facility Information:
Facility Name
Brandywine Counseling and Community Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Disclosure Intervention for People in Recovery From Opioid Use Disorder

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