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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20GM130418 | U.S. NIH Grant/Contract | View source |
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The protocol is determined to no longer be able to meet study objectives due to failure to enroll participants within the requisite time period.
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.
Participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. Participants will also be asked to complete self-report measures before and after each session. The primary aims of this study are as follows.
Aim 1: To adapt the in-person MORE intervention for telehealth delivery. Aim 2: To assess the overall feasibility and acceptability of this telehealth intervention. Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement via tele-health | Experimental | Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Behavioral | MORE is a mindfulness-based intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction | Participants will complete the Client Satisfaction Questionnaire. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SUD Symptoms - Mini Neuropsychiatric Interview | The Mini Neuropsychiatric Interview is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-V. For this study, we conducted a structured interview with participants to determine the number of symptoms of substance use disorder they had experienced in the past year. After completing eight sessions of Mindfulness-Oriented Recovery Enhancement, we conducted the same interview to learn the number of symptoms of substance use disorder participants had experienced in the past eight weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Reese | University of Montana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Montana | Missoula | Montana | 59802 | United States |
We did not exclude any participants from the study before assignment to groups.
Study recruitment began 2/10/21 upon IRB approval and ended on 5/1/22. Recruitment efforts included outreach to OBGYN providers, healthcare systems, pain management clinics, substance use treatment providers, community groups, and harm reduction services. Providers and community members were asked to refer potential participants to the study and to post flyers. The team also advertised online through social media.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Oriented Recovery Enhancement Via Tele-health | Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Oriented Recovery Enhancement Via Tele-health | Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Client Satisfaction | Participants will complete the Client Satisfaction Questionnaire. | Participant did not complete this measure. | Posted | 8 weeks |
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Adverse event data were collected during the time the participant was engaged in the study, about 10 weeks.
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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 | Mindfulness-Oriented Recovery Enhancement Via Tele-health | Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Mindfulness-Oriented Recovery Enhancement: MORE is a mindfulness-based intervention. |
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Unable to recruit the number of participants anticipated possibly due to stigma related to substance use in pregnancy, as well as challenges related to Covid-19 and the impact of the pandemic on healthcare and social service systems.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Reese | University of Montana | 7313940288 | Sarah.reese@mso.umt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2021 | Jan 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2021 | Jan 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 8 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| SUD Symptoms - Mini Neuropsychiatric Interview - Alcohol Use Disorder | The Mini Neuropsychiatric Interview is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-V. For this study, we conducted a structured interview with participants to determine the number of symptoms of substance use disorder they had experienced in the past year. After completing eight sessions of Mindfulness-Oriented Recovery Enhancement, we conducted the same interview to learn the number of symptoms of substance use disorder participants had experienced in the past eight weeks. | Mean | Full Range | symptoms |
|
| Secondary | SUD Symptoms - Mini Neuropsychiatric Interview | The Mini Neuropsychiatric Interview is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-V. For this study, we conducted a structured interview with participants to determine the number of symptoms of substance use disorder they had experienced in the past year. After completing eight sessions of Mindfulness-Oriented Recovery Enhancement, we conducted the same interview to learn the number of symptoms of substance use disorder participants had experienced in the past eight weeks. | Posted | Number | symptoms | 8 weeks |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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