Cannabis Use, Perinatal, Smoking Cessation, Tobacco Use
Conditions
Keywords
tobacco, perinatal, pregnancy, smoking, cessation, postpartum, cannabis, intervention
Brief summary
Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.
Interventions
BEHAVIORALPerinatal smoking cessation treatment and maintenance sessions
Participants will meet one-on-one with a study interventionist over the course of 6 prenatal treatment sessions and 3 postpartum maintenance sessions. Sessions will include education and discussion on self-monitoring of targets/ problem identification, psychoeducation, behavioral activation, cognitive restructuring, and mindfulness skills.
Sponsors
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed pregnant * Under 26 weeks gestation * Plan to remain pregnant * English speaking * Use of combustible tobacco at least once a week during pregnancy, or at least once a week in the 3 months before pregnancy if stopped * Use of cannabis at any frequency during pregnancy or in the 3 months before pregnancy if stopped
Exclusion criteria
* Current opioid use or active treatment for Opioid Use Disorder * Unable to provide informed consent in English * Under 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance | From enrollment to 3 months postpartum | Rate of attendance will be measured by proportion of sessions attended to total available sessions. |
| Completion of Intervention-Related Procedures | From enrollment to 3 months postpartum | Participant will complete activities designed to help them self-monitor their smoking-related behaviors during and between scheduled treatment sessions. Completion of activities will be measured by the proportion of completed activities to the total number of assigned activities. |
| Acceptability of the Intervention | From enrollment to 3 months postpartum | Participants' acceptance of the intervention will be measured using the Acceptability of Intervention Measure (AIM) at the 3-month postpartum assessment. This is a 4-item questionnaire with a scale range of 4-20, with a higher score indicating greater acceptance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence from Tobacco Products | Baseline assessment to 3 months postpartum | Abstinence from tobacco products will be measured by proportion of the participants who self-report no use of tobacco and by calculating the proportion of participants with negative urine screens for cotinine at the 3-month postpartum assessment. |
| Abstinence from Cannabis Products | Baseline assessment to 3 months postpartum. | Abstinence from cannabis products will be measured by proportion of the participants who self-report no use of cannabis and by calculating the proportion of participants with negative urine screens for THC at the 3-month postpartum assessment. |
| Depressive Symptoms from Baseline | Baseline assessment to 3 months postpartum | Change in depressive symptoms will be measured through self-report Edinburgh Postnatal Depression Scale (EPDS) at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. The scale range is 0-30, with a higher score indicating higher depression. |
| Change in Tobacco Use from Baseline | Baseline assessment to 3 months postpartum | Change in tobacco use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. |
| Change in Cannabis Use from Baseline | Baseline assessment to 3 months postpartum | Change in cannabis use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. |
Countries
United States
Contacts
CONTACTProject Coordinator
PRINCIPAL_INVESTIGATORNatacha De Genna
University of Pittsburgh
Outcome results
None listed