- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04836247
Disclosure Intervention for People in Recovery From Opioid Use Disorder
January 29, 2024 updated by: Valerie Earnshaw, University of Delaware
Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Delaware
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Wilmington, Delaware, United States, 19805
- Brandywine Counseling and Community Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: Control Arm
Participants will be able to choose from several guided meditations to promote mindfulness.
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Participants will be able to choose from several guided meditations to promote mindfulness
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention
Time Frame: Assessed immediately following intervention delivery, at time 1 study appointment.
|
Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017).
Mean scores range 1-5, with higher scores indicating greater acceptability.
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Assessed immediately following intervention delivery, at time 1 study appointment.
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Feasibility of Intervention
Time Frame: Assessed immediately following intervention delivery, at time 1 study appointment.
|
Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017).
Mean scores range 1-5, with higher scores indicating greater feasibility.
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Assessed immediately following intervention delivery, at time 1 study appointment.
|
Decision Making Quality
Time Frame: Assessed immediately following intervention delivery, at time 1 study appointment.
|
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.
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Assessed immediately following intervention delivery, at time 1 study appointment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Support
Time Frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
|
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.
|
Enacted Stigma
Time Frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
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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.
|
Commitment to Sobriety
Time Frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
|
Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Mean scores range 1-6, higher scores indicate greater commitment to sobriety.
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Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2021
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
April 2, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01DA042881 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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