Trial Outcomes & Findings for Disclosure Intervention for People in Recovery From Opioid Use Disorder (NCT NCT04836247)
NCT ID: NCT04836247
Last Updated: 2024-01-31
Results Overview
Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017). Mean scores range 1-5, with higher scores indicating greater acceptability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Assessed immediately following intervention delivery, at time 1 study appointment.
Results posted on
2024-01-31
Participant Flow
Participant milestones
| Measure |
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.
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.
|
Control Arm
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disclosure Intervention for People in Recovery From Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Disclosure Intervention Arm
n=25 Participants
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.
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.
|
Control Arm
n=25 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.04 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
42.04 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
41.54 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Disclosure Intervention Arm
n=25 Participants
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.
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.
|
Control Arm
n=25 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Acceptability of Intervention
|
4.82 score on a scale
Standard Deviation 0.34
|
3.19 score on a scale
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Disclosure Intervention Arm
n=25 Participants
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.
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.
|
Control Arm
n=25 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Feasibility of Intervention
|
4.88 score on a scale
Standard Deviation 0.32
|
3.78 score on a scale
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Disclosure Intervention Arm
n=25 Participants
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.
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.
|
Control Arm
n=25 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Decision Making Quality
|
4.49 score on a scale
Standard Deviation 0.59
|
1.88 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Disclosure Intervention Arm
n=24 Participants
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.
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.
|
Control Arm
n=23 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Social Support
|
3.17 score on a scale
Standard Deviation 1.17
|
3.29 score on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.Measure adapted from Methadone Maintenance Treatment Stigma Mechanisms Scale (Smith et al., 2019); Mean scores range 1-5, higher scores indicate greater stigma.
Outcome measures
| Measure |
Disclosure Intervention Arm
n=24 Participants
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.
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.
|
Control Arm
n=23 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Enacted Stigma
|
1.83 score on a scale
Standard Deviation 0.72
|
1.91 score on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Disclosure Intervention Arm
n=24 Participants
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.
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.
|
Control Arm
n=23 Participants
Participants will be able to choose from several guided meditations to promote mindfulness.
Mindfulness: Participants will be able to choose from several guided meditations to promote mindfulness
|
|---|---|---|
|
Commitment to Sobriety
|
5.48 score on a scale
Standard Deviation 0.70
|
5.62 score on a scale
Standard Deviation 0.53
|
Adverse Events
Disclosure Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place