Testing the Efficacy of Mindfulness-based Stress Reduction in the Prevention of Perimenopausal Depression
Condition: Perimenopausal Depression; Depressive Symptoms
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression is the leading cause of disability worldwide and a risk factor for other diseases.
      While women are at elevated risk for depression in general, the menopause transition is a
      particularly vulnerable time for many women, with the risk for depression increasing 2-4
      fold. The objective of this research study is to determine whether mindfulness-based stress
      reduction (MBSR), an 8-week structured intervention involving meditation and yoga, has any
      beneficial mood effects for women undergoing this vulnerable time.
    

Detailed description: 
      The menopause transition (a.k.a. perimenopause) represents the reproductive stage
      transitioning from regular menstrual cycles through the loss of ovulatory function and to the
      complete cessation of menses. The latter marks the onset of menopause. All middle-aged women
      experience the menopause transition, which, on average, extends 5-6 years surrounding the
      last menstrual period. In Saskatchewan, roughly 80 000 women are currently of perimenopausal
      age. An estimated 26-33% of women develop clinically significant depressive symptoms during
      the perimenopause. Rates of diagnosed major depressive disorder during the menopause
      transition range between 12 and 23%. Mounting evidence findings from the PI and others
      suggests that the erratic fluctuations in estradiol that occur during the normal menopause
      transition play a key role. Specifically, increased estradiol fluctuation may increase one's
      sensitivity to stress both in the laboratory and in the context of real-world stressful life
      events, resulting in an increased risk for clinically significant depressive symptoms.

      MBSR has proven to be very effective at increasing stress resilience and improving emotional
      wellbeing in a variety of populations. Thus, in the current SHRF-funded project, we will
      examine the prophylactic mood benefits of MBSR. We hypothesize that MBSR will increase
      women's resilience in the context of stress-sensitizing hormonal fluctuation in the menopause
      transition, making them less prone to developing depressive symptoms.

      The current project will be composed of five components: 1) Enrollment session; 2) Hormonal
      Sensitivity Assessment (1 month); 3) Treatment Phase (8 weeks); 4) Follow-Up Phase (6 months)
      and 5) Waitlist Control Group Treatment (8 weeks). Each component is described in detail
      below:

        1. Enrollment Session. After completing an eligibility screening over the phone, a trained
           research assistant (RA) will conduct an enrollment session over the phone with the
           prospective participant. The participant will be emailed a Powerpoint presentation
           summarizing the study and a link to a Qualtrics survey that will contain an electronic
           version of the consent form. Over the phone, the RA will review the Powerpoint slides
           and consent form. Once consent is obtained, the RA will administer the Structured
           Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5
           (SCID-RV) for axis I disorders to screen for the presence of current psychiatric
           disorders as well as assess past major depressive episodes. The participant will then
           follow the RA's instructions on how to download the Expimetrics application on their
           smart phone, which they will use to complete study component #2 (described below). After
           the phone call, participants will be emailed a link to a Qualtrics survey containing a
           number of questionnaires assessing demographic information as well as psychological
           variables that may predict participant outcomes. The RA will instruct the participant to
           complete the survey at their convenience over the following 7 days. The RA will also
           mail a kit containing 12 2-ml vials contained in a small cardboard box and 10 ovulation
           predictor tests. Next, participants will complete an electronic version of a number of
           questionnaires, described below, with the use of Qualtrics. Finally, participants will
           be given instructions on how to take an ovulation test and how to collect urine samples
           at home.

        2. Hormonal Sensitivity Assessment (1.5 months). Starting on the first day of their next
           menstrual period following the enrolment session, participants will complete the Daily
           Rating of Severity of Problems (DRSP) for approximately 45 days (if possible, using the
           Expimetrics smart phone app). Starting on day seven of their menstrual cycle, they will
           take an ovulation predictor test upon waking each day until a positive test is obtained
           (usually 6-8 days). Once a positive test is obtained, the participant will notify a
           research assistant by text, email or phone. In addition, they will be asked to collect a
           small sample of urine every other day for 30 days. The DRSP should be completed daily
           until the last day of urine collection.

        3. MBSR Intervention (8 weeks). The intervention is provided over the course of eight
           weekly 150-minute sessions and one 7-hour weekend intensive silent retreat. The MBSR
           program, modeled after the work of Jon Kabat-Zinn and colleagues at the Stress Reduction
           and Relaxation Clinic-Massachusetts Medical Center, has been used and adapted by Dr.
           Campbell and his colleagues at the University of Calgary for numerous populations. The
           MBSR program consists of three primary components: 1) theoretical material related to
           relaxation, meditation, and the body-mind connection, 2) experiential practice of
           meditation and yoga during the group meetings and home based practice, and 3) group
           process focused on problem solving related to impediments to effective practice,
           practical day-to-day applications of mindfulness, and supportive interaction between
           group members. A booklet is distributed containing information pertinent to each week's
           instruction, including a bibliography for those wishing to pursue relevant themes in
           greater depth, and 2 CDs with guided meditation to help with home practice. Each week,
           participants will be asked to record all between-session home practice.

           All sessions will be audiotaped; audiotapes will be randomly selected to be viewed by
           Dr. Campbell to monitor treatment fidelity. After evaluating the tapes, both written and
           verbal feedback will be provided to the instructor to support compliance with the
           treatment protocol. Note that audiotapes will not reveal the identity of any of the
           participants.

        4. Follow-up Period (6 months). Immediately following the intervention and every two weeks
           for 6 months, participants from both treatment groups will be emailed a link to a
           Qualtrics survey including the CES-D. The following questionnaires will also be included
           in the survey immediately following the intervention as well as months 2, 4 and 6: the
           Perceived Stress Scale, the State-Trait Anxiety Inventory, the Five Facet Mindfulness
           Questionnaire and the Connor-Davidson Resilience Scale. For participants without an
           email address, an RA will complete the survey with them over the phone. Participants
           obtaining a CES-D score ≥16 will be contacted by an RA to complete the mood module of
           the SCID-5 over the phone to identify cases of major depression. Importantly, all
           post-randomization correspondence with participants will be carried out by staff members
           who are blinded to participants' treatment condition.

        5. Waitlist MBSR Intervention (8 weeks). Following the six-month follow-up, members of each
           wave's waitlist control group will receive the MBSR intervention. Although this will
           serve no research purpose, we believe offering MBSR to all participants, rather than
           using a "no treatment" condition will make the trial more equitable and appealing.
    

Intervention name(s): Mindfulness-based stress reduction
Intervention type(s): Behavioral
Intervention description(s): 8 weekly 2.5-hour group sessions of mindfulness based stress reduction, led by a certified MBSR instructor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A stratified randomization method will be used to balance the number of baseline stressful life events in each treatment group (<3 vs. 3+ in the last 6 months). Randomization will be performed once baseline stressful life events are determined.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mindfulness based stress reduction; Perimenopausal depression; Menopause transition