The Mindful Pregnancy Study: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Phase: NA
Conditions: Opioid-use Disorder
Sponsor: University of Montana

PROTOCOL: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement with 
Pregnant Women with Opioid Use Disorder  
 
Clinicaltrials.gov IdenIﬁer: NCT04824521 
 
PRINCIPAL INVESTIGATOR: Sarah Reese, School of Social Work, University of Montana, 406-243-
5543 
 
DOCUMENT DATE: February 10, 2021 
 
ATTACHMENTS:  
 
Study Protocol  
 
Data CollecIon Forms 
 
Data Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
 
OBJECTIVES 
 
The primary objec/ve of this study is to evaluate the feasibility and acceptability of a behavioral health interven/on 
(Mindfulness-Oriented Recovery Enhancement) delivered via telehealth to pregnant women diagnosed with 
substance use disorder. We have been awarded a pilot grant through the University of Montana Center for 
Popula/on Health Research to complete this research. We propose to recruit thirty pregnant women with 
substance use disorder from clinics, community organiza/ons, and social media to par/cipate in eight sessions of 
Mindfulness-Oriented Recovery Enhancement (MORE) via Zoom. We propose to conduct all study visits remotely 
via Zoom and are therefore asking to be able to consent par/cipates remotely via Zoom as well.  
 
Study visits would include (1) a pre-treatment assessment, (2) eight therapy sessions, (3) a mid-treatment 
assessment aOer four therapy sessions, and (4) a post-treatment assessment (see aQached study /meline). During 
the pre-, mid-, and post-treatment assessment visits, par/cipants will be asked to complete self-report measures 
(see aQached), two structured clinical interviews (see aQached) and a semi-structured qualita/ve interview (see 
aQached). Par/cipants will be asked to complete a brief ques/onnaire (see aQached) before and aOer each session. 
The primary aims of this study are as follows.  
 
Aim 1: To adapt the in-person MORE interven/on for telehealth delivery.  
Aim 2: To assess the overall feasibility and acceptability of this telehealth interven/on.  
Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to par/cipants.  
 
DESIGN 
 
In this study, we intend to recruit pregnant women with SUD. This study is speciﬁcally focused on evalua/ng the 
feasibility and acceptability of a behavioral health interven/on for this popula/on.  
 
Women are eligible to be a part of the study if they (1) are 18 years old or older, (2) are able to speak and 
understand English, (3) are pregnant at the /me of consent, (4) meet criteria for substance use disorder in the past 
year according to the Mini Neuropsychiatric Interview, and (5) have access to the internet and a smart device 
(though a tablet may be provided). Whether a par/cipant meets criteria for SUD will not be known un/l the 
interview is conducted during the pre-assessment, but since we will be collec/ng sensi/ve informa/on (i.e., 
symptoms of substance use disorder), we need to complete the informed consent process. 
 
Par/cipants will be recruited through two approaches. We will reach out to OBGYN providers, healthcare systems, 
pain management clinics, substance use treatment provides, health departments, community groups, and harm 
reduc/on services to adver/se the study. These providers will be given ﬂyers (see aQached) to post and distribute 
to pa/ents/clients. We will also adver/se online through social media (see aQached).  
 
Poten/al par/cipants will be instructed to call, text, or email the research team to par/cipate in the study. To be a 
part of the study, women must  
(1) be 18 years old or older,  
(2) be able to speak and understand English,  
(3) be pregnant at the /me of consent, and  
(4) meet criteria for substance use disorder in the past year according to the Mini Neuropsychiatric Interview (see 
aQached)  
(5) have access to the internet and a smart device (a table may be provided). 
 
Again, we will not know if the par/cipant meets criteris for SUD un/l the interview is conducted during the pre-
treatment assessment. 

 
METHODS 
 
Here we provide an outline of the study procedures for study par/cipants. 
 
1. Poten/al par/cipants will contact study staﬀ via phone, text, or email to enroll in the study.  
 
2. Study staﬀ will describe the study in detail, answer ques/ons, and evaluate the poten/al par/cipant for eligibility 
criteria.  
 
3. If the poten/al par/cipant is s/ll interested in the study and meets all inclusion criteria, they will then set up a 
virtual appointment via Zoom to complete the pre-assessment visit.  
 
4. During the pre-assessment visit, study staﬀ will engage the par/cipant in the informed consent process. AOer 
comple/ng the informed consent process, par/cipants will complete self-report measures, structured clinical 
interviews, and a semi-structured qualita/ve interview.  
        a. Par/cipants will be asked to complete a baQery of self-report measures including a demographic 
ques/onnaire and measures of paren/ng conﬁdence and self-regula/on (see below) via Qualtrics.  
        b. Study staﬀ will conduct the Mini Neuropsychiatric Interview and the NIDA Modiﬁed Assist Tool (see 
aQached).  
        c. Par/cipants will engage in a semi-structured qualita/ve interview (see aQached).  
 
5. AOer comple/ng the pre-treatment assessment via Zoom, study staﬀ will schedule the ﬁrst tele-health 
appointment.  
 
6. Par/cipants will complete four tele-health appointments via Zoom. These therapy sessions will last about one 
hour. Par/cipants will complete a short ques/onnaire before and aOer the session (see aQached). MORE sessions 
will begin with formal mindfulness prac/ce followed by a debrief of the formal prac/ce, psychoeduca/on, and an 
experimental exercise. Sessions will focus on the applica/on of mindfulness, cogni/ve reappraisal, and savoring in 
managing pain, substance use, and stress related to paren/ng and rela/onships. All sessions will be audio-
recorded, reviewed and scored using a ﬁdelity measure by research assistants trained in MORE to ensure ﬁdelity to 
the treatment.      
 
7. Outside of therapy sessions, par/cipants will be asked to complete ﬁOeen minutes of homework per day during 
which they will prac/ce mindfulness, reappraisal, and savoring techniques. Mindfulness techniques will include 
body scan (during which par/cipants focus on sensa/ons in their bodies), mindful breathing (during which 
par/cipants focus on the sensa/on of breathing), and open monitoring mindfulness prac/ce (during which the 
focus of aQen/on is awareness itself and par/cipants simply no/ce as thoughts and sensa/ons arise). Mindful 
reappraisal is the applica/on of mindfulness to restructure (or change) unhlepful thoughts to reduce nega/ve 
feelings and unhelpful behavior. Savoring is the applica/on of mindfulness to focus on and inhance pleasurable 
thoughts, feelings, and sensa/ons.  
 
8. AOer four therapy sessions, par/cipants will complete a mid-treatment assessment via Zoom. Par/cipants will 
complete the same self-report measures, structured clinical interviews, and semi-structured qualita/ve interview 
which they completed in the pre-treatment assessment.   
 
9. Par/cipants will complete the four remaining therapy sessions.  
 
10. AOer comple/ng the remaining therapy sessions, par/cipants will complete a post-treatment assessment via 
Zoom. Par/cipants will complete the same self-report measures, structured clinical interviews, and semi-structured 
qualita/ve interview which they completed in the pre-treatment and mid-treatment assessments.