Opioid-use Disorder
Conditions
Brief summary
Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.
Detailed description
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.
Interventions
MORE is a mindfulness-based intervention.
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Montana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Must be pregnant. * Must be able to communicate in English. * Must have met criteria for opioid use disorder in the past year.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction | 8 weeks | Participants will complete the Client Satisfaction Questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUD Symptoms - Mini Neuropsychiatric Interview | 8 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
We did not exclude any participants from the study before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Mindfulness-Oriented Recovery Enhancement Via Tele-health |
|---|---|
| Age, Continuous | 31 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
| SUD Symptoms - Mini Neuropsychiatric Interview - Alcohol Use Disorder | 12 symptoms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Client Satisfaction
Participants will complete the Client Satisfaction Questionnaire.
Time frame: 8 weeks
Population: Participant did not complete this measure.
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.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement Via Tele-health | SUD Symptoms - Mini Neuropsychiatric Interview | 12 symptoms |