Opioid-use Disorder
Conditions
Keywords
disclosure, social support, stigma, patient decision aid
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.
Interventions
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.
BEHAVIORALMindfulness
Participants will be able to choose from several guided meditations to promote mindfulness
Sponsors
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Harvard School of Public Health (HSPH)
Harvard Medical School (HMS and HSDM)
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Support | 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. |
| Enacted Stigma | 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. |
| Commitment to Sobriety | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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 | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Control Arm | Total | Disclosure Intervention Arm |
|---|---|---|---|
| Age, Continuous | 42.04 years STANDARD_DEVIATION 11.32 | 41.54 years STANDARD_DEVIATION 11.03 | 41.04 years STANDARD_DEVIATION 10.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 48 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: Assessed immediately following intervention delivery, at time 1 study appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disclosure Intervention Arm | Acceptability of Intervention | 4.82 score on a scale | Standard Deviation 0.34 |
| Control Arm | Acceptability of Intervention | 3.19 score on a scale | Standard Deviation 1.14 |
p-value: <0.001t-test, 2 sided
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.
Time frame: Assessed immediately following intervention delivery, at time 1 study appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disclosure Intervention Arm | Decision Making Quality | 4.49 score on a scale | Standard Deviation 0.59 |
| Control Arm | Decision Making Quality | 1.88 score on a scale | Standard Deviation 0.98 |
p-value: <0.001t-test, 2 sided
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.
Time frame: Assessed immediately following intervention delivery, at time 1 study appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disclosure Intervention Arm | Feasibility of Intervention | 4.88 score on a scale | Standard Deviation 0.32 |
| Control Arm | Feasibility of Intervention | 3.78 score on a scale | Standard Deviation 0.84 |
p-value: <0.001t-test, 2 sided
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.
Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disclosure Intervention Arm | Commitment to Sobriety | 5.48 score on a scale | Standard Deviation 0.7 |
| Control Arm | Commitment to Sobriety | 5.62 score on a scale | Standard Deviation 0.53 |
p-value: 0.44t-test, 2 sided
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.
Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disclosure Intervention Arm | Enacted Stigma | 1.83 score on a scale | Standard Deviation 0.72 |
| Control Arm | Enacted Stigma | 1.91 score on a scale | Standard Deviation 1.03 |
p-value: 0.76t-test, 2 sided
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.
Time frame: Second study appointment out of two. Second appointment took place approximately one month after first study appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disclosure Intervention Arm | Social Support | 3.17 score on a scale | Standard Deviation 1.17 |
| Control Arm | Social Support | 3.29 score on a scale | Standard Deviation 1.38 |
p-value: 0.74t-test, 2 sided