Disclosure Intervention for People in Recovery From Opioid Use Disorder

NCT ID: NCT04836247

Last Updated: 2024-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2022-08-31

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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Disclosing Recovery: A Decision Aid and Toolkit

Intervention Type 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.

Control Arm

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

Group Type ACTIVE_COMPARATOR

Mindfulness

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Mindfulness

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Valerie Earnshaw

Associate Professor of Human Development and Family Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brandywine Counseling and Community Services

Wilmington, Delaware, United States

Site Status

Countries

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United States

References

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Earnshaw VA, Sepucha KR, Laurenceau JP, Subramanian SV, Hill EC, Wallace J, Brousseau NM, Henderson C, Brohan E, Morrison LM, Kelly JF. Disclosing Recovery: A pilot randomized controlled trial of a patient decision aid to improve disclosure processes for people in treatment for opioid use disorder. J Subst Use Addict Treat. 2024 May;160:209291. doi: 10.1016/j.josat.2024.209291. Epub 2024 Jan 23.

Reference Type DERIVED
PMID: 38272118 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

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K01DA042881

Identifier Type: NIH

Identifier Source: secondary_id

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K01DA042881

Identifier Type: NIH

Identifier Source: org_study_id

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