Opioid-use DisorderNCT04836247
Disclosure Intervention for People in Recovery From Opioid Use Disorder
A study testing Disclosing Recovery: A Decision Aid and Toolkit and Mindfulness in people with Opioid-use Disorder, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Disclosing Recovery: A Decision Aid and Toolkit and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- current diagnosis of severe mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Brandywine Counseling and Community Services
Wilmington, Delaware, 19805
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Disclosing Recovery: A Decision Aid and Toolkit, Mindfulness
- Keywords
- disclosure, social support, stigma, patient decision aid
- Medical subject headings
- Opioid-Related Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosing Recovery: A Decision Aid and ToolkitBehavioural
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.
MindfulnessBehavioural
Participants will be able to choose from several guided meditations to promote mindfulness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed immediately following intervention delivery, at time 1 study appointment.
Secondary outcomes (3)
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.
Measured: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
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.
Measured: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
Commitment to Sobriety
Measured with Commitment to Sobriety Scale (Kelly \& Greene, 2014); Mean scores range 1-6, higher scores indicate greater commitment to sobriety.
Measured: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start26 Jul 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Massachusetts General Hospital, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Valerie Earnshaw, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836247
- Sponsor's protocol ID
- K01DA042881
- Other IDs
- K01DA042881
- Status last verified
- Jan 2024
- First submitted
- 2 Apr 2021
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38272118
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders
- ClinicalTrials.gov ID
- NCT04836247
- Acronym / sponsor ID
- K01DA042881
- Conditions
- Opioid-use Disorder
- Keywords
- disclosure, social support, stigma, patient decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Massachusetts General Hospital, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disclosure Intervention Arm | Experimental | Behavioral: Disclosing Recovery: A Decision Aid and ToolkitParticipants 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 | Active comparator | Behavioral: MindfulnessParticipants will be able to choose from several guided meditations to promote mindfulness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- current diagnosis of severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disclosing Recovery: A Decision Aid and ToolkitParticipants 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. | Behavioural | Disclosure Intervention Arm |
| MindfulnessParticipants will be able to choose from several guided meditations to promote mindfulness | Behavioural | Control Arm |
Primary outcome
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.
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.
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.
3 secondary outcomes
Social Support
Time frame: 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.
Commitment to Sobriety
Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38272118Earnshaw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosing Recovery: A Decision Aid and Toolkit and Mindfulness in people with Opioid-use Disorder, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention (time frame: Assessed immediately following intervention delivery, at time 1 study appointment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.