Disclosure Intervention for People in Recovery From Opioid Use Disorder

NCT04836247 | Completed Results

• 1 other identifier: K01DA042881
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

disclosure; social support; stigma; patient decision aid

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention

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

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

• Feasibility of Intervention

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

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

• Decision Making Quality

  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.

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

Secondary Outcomes (3)

• Social Support

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

• Enacted Stigma

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

• Commitment to Sobriety

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

Study Arms (2)

Disclosure Intervention Arm

EXPERIMENTAL

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

Control Arm

ACTIVE COMPARATOR

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

Behavioral: Mindfulness

Interventions

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.

Disclosure Intervention Arm

Mindfulness BEHAVIORAL

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• current diagnosis of severe mental illness

Sponsors & Collaborators

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

Study Sites (1)

Brandywine Counseling and Community Services

Wilmington, Delaware, 19805, United States

Location

Related Publications (1)

• 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.

  PMID: 38272118 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Social Stigma

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Valerie Earnshaw
• Organization: University of Delaware

earnshaw@udel.edu

302-831-4772

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Human Development and Family Sciences

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: July 26, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)