Disclosure Intervention for People in Recovery From Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836247
• Other study ID #: K01DA042881
• Secondary ID: K01DA042881
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Brandywine Counseling and Community Services	Wilmington	Delaware

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Social Support	Measure adapted from Medical Outcomes Study Social Support Survey (Moser et al., 2012); Mean scores range 1-5, higher scores indicate more social support.	Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
Secondary	Enacted Stigma	Measure adapted from Methadone Maintenance Treatment Stigma Mechanisms Scale (Smith et al., 2019); Mean scores range 1-5, higher scores indicate greater stigma.	Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
Secondary	Commitment to Sobriety	Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Mean scores range 1-6, higher scores indicate greater commitment to sobriety.	Second study appointment out of two. Second appointment took place approximately one month after first study appointment.