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Completed
NCT05528380
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
Conditions: Pregnancy, Cannabis
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 16
Sponsor: Butler Hospital
Location: Butler Hospital Providence Rhode Island
Summary
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.
Eligibility Criteria
Inclusion Criteria:
* Women aged 18+
* 12-25 weeks gestation with a healthy singleton pregnancy
* Medically cleared for moderate physical activity
* Self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use
* Elevated depression (EPDS\>=7) or anxiety (GAD7\>=5)
* English-speaking
* Owns a smartphone to enable use of the Fitbit app
* Current physical activity does not meet health recommendations (150 min/week mod intensity activity)
* Expresses interest in reducing or discontinuing cannabis use
Exclusion Criteria:
* Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD or nicotine use disorder
* Use of illicit substances in the last 3 months (other than cannabis)
* Acute psychotic symptoms
* Current or recent suicidality or homicidally
* Current anorexia or bulimia
* Cognitive impairment
* Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn)
* Has a plan to relocate away from the area during study period
* Recently started new mental health or substance use treatment within past 4 weeks.
Source: ClinicalTrials.gov (NCT05528380). StuddyBuddy aggregates publicly available trial information.