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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA042881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Massachusetts General Hospital | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Harvard Medical School (HMS and HSDM) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Arm | Active Comparator | Participants will be able to choose from several guided meditations to promote mindfulness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disclosing Recovery: A Decision Aid and Toolkit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Assessed immediately following intervention delivery, at time 1 study appointment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Second study appointment out of two. Second appointment took place approximately one month after first study appointment. |
| Enacted Stigma |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandywine Counseling and Community Services | Wilmington | Delaware | 19805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38272118 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed immediately following intervention delivery, at time 1 study appointment. |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Earnshaw | University of Delaware | 302-831-4772 | earnshaw@udel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2021 | Jan 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2021 | Aug 4, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| OTHER |
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| Mindfulness | Behavioral | Participants will be able to choose from several guided meditations to promote mindfulness |
|
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 | Measured with Commitment to Sobriety Scale (Kelly & Greene, 2014); Mean scores range 1-6, higher scores indicate greater commitment to sobriety. | Second study appointment out of two. Second appointment took place approximately one month after first study appointment. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed immediately following intervention delivery, at time 1 study appointment. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed immediately following intervention delivery, at time 1 study appointment. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Second study appointment out of two. Second appointment took place approximately one month after first study appointment. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Second study appointment out of two. Second appointment took place approximately one month after first study appointment. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Second study appointment out of two. Second appointment took place approximately one month after first study appointment. |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012919 | Social Behavior |
| D001519 | Behavior |