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Completed

NCT Number: NCT04836247

Disclosure Intervention for People in Recovery From Opioid Use Disorder

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.

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Key information

Conditions

Opioid-use Disorder Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Social Behavior Social Stigma Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brandywine Counseling and Community Services

Wilmington, Delaware, 19805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disclosing Recovery: A Decision Aid and Toolkit

Behavioral

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.

Mindfulness

Behavioral

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

Primary outcomes

  1. Acceptability of Intervention

    Time frame: Assessed immediately following intervention delivery, at time 1 study appointment.

    Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017). Mean scores range 1-5, with higher scores indicating greater acceptability.

  2. Feasibility of Intervention

    Time frame: Assessed immediately following intervention delivery, at time 1 study appointment.

    Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017). Mean scores range 1-5, with higher scores indicating greater feasibility.

  3. Decision Making Quality

    Time frame: Assessed immediately following intervention delivery, at time 1 study appointment.

    Measured informed by recommendations for evaluating patient decision aids (Sepucha et al., 2013), focused on recognition of decision. Mean scores range 1-5, with higher scores indicating greater decision making quality.

Secondary outcomes

  1. Social Support

    Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.

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

  2. Enacted Stigma

    Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.

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

  3. Commitment to Sobriety

    Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.

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

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

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

Registry information

Official study title

Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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