Disclosure Intervention for People in Recovery From Opioid Use Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Disclosing Recovery: A Decision Aid and Toolkit
* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disclosure Intervention Arm<br>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<br>* 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.<br>|
| Active Comparator: Control Arm<br>Participants will be able to choose from several guided meditations to promote mindfulness. | Behavioral: Mindfulness<br>* Participants will be able to choose from several guided meditations to promote mindfulness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention | Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017) | Month 0, immediately following intervention delivery | 
| Feasibility of Intervention | Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017) | Month 0, immediately following intervention delivery | 
| 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) | Month 0, immediately following intervention delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 1, at follow-up appointment | 
| Enacted Stigma | Measure adapted from Methadone Maintenance Treatment Stigma Mechanisms Scale (Smith et al., 2019); Scores range 1-5, higher scores indicate greater stigma | Month 1, at follow-up appointment | 
| Commitment to Sobriety | Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Scores range 1-6, higher scores indicate greater commitment to sobriety | Month 1, at follow-up appointment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disclosure, social support, stigma, patient decision aid