Disclosure Intervention for People in Recovery From Opioid Use Disorder

Sponsor
University of Delaware (Other)
Overall Status
Recruiting
CT.gov ID
NCT04836247
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Massachusetts General Hospital (Other), Harvard School of Public Health (HSPH) (Other), Harvard Medical School (HMS and HSDM) (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Disclosing Recovery: A Decision Aid and Toolkit
  • Behavioral: Mindfulness
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Disclosure Intervention Arm

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.

Behavioral: Disclosing Recovery: A Decision Aid and Toolkit
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.

Active Comparator: Control Arm

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

Behavioral: Mindfulness
Participants will be able to choose from several guided meditations to promote mindfulness

Outcome Measures

Primary Outcome Measures

  1. Acceptability of Intervention [Month 0, immediately following intervention delivery]

    Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017)

  2. Feasibility of Intervention [Month 0, immediately following intervention delivery]

    Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017)

  3. Decision Making Quality [Month 0, immediately following intervention delivery]

    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

  1. Social Support [Month 1, at follow-up appointment]

    Measure adapted from Medical Outcomes Study Social Support Survey (Moser et al., 2012); Scores range 1-5, higher scores indicate more social support

  2. Enacted Stigma [Month 1, at follow-up appointment]

    Measure adapted from Methadone Maintenance Treatment Stigma Mechanisms Scale (Smith et al., 2019); Scores range 1-5, higher scores indicate greater stigma

  3. Commitment to Sobriety [Month 1, at follow-up appointment]

    Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Scores range 1-6, higher scores indicate greater commitment to sobriety

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brandywine Counseling and Community Services Wilmington Delaware United States 19805

Sponsors and Collaborators

  • University of Delaware
  • National Institute on Drug Abuse (NIDA)
  • Massachusetts General Hospital
  • Harvard School of Public Health (HSPH)
  • Harvard Medical School (HMS and HSDM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valerie Earnshaw, Associate Professor of Human Development and Family Sciences, University of Delaware
ClinicalTrials.gov Identifier:
NCT04836247
Other Study ID Numbers:
  • K01DA042881
  • K01DA042881
First Posted:
Apr 8, 2021
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Valerie Earnshaw, Associate Professor of Human Development and Family Sciences, University of Delaware
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022