Clinical trial NCT04836247: Disclosure Intervention for People in Recovery From Opioid Use Disorder
Official title: Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: disclosure
social support
stigma
patient decision aid
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Massachusetts General Hospital
name: Harvard School of Public Health (HSPH)
name: Harvard Medical School (HMS and HSDM)
First posted: 2021-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: Assessed immediately following intervention delivery, at time 1 study appointment.
measure: Feasibility of Intervention
timeFrame: Assessed immediately following intervention delivery, at time 1 study appointment.
measure: Decision Making Quality
timeFrame: Assessed immediately following intervention delivery, at time 1 study appointment.
Secondary outcomes:
measure: Social Support
timeFrame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
measure: Enacted Stigma
timeFrame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
measure: Commitment to Sobriety
timeFrame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Brandywine Counseling and Community Services
state: Delaware
Study officials:
References: