Testing the Efficacy of Mindfulness-based Stress Reduction in the Prevention of Perimenopausal Depression

NCT03526523 | Completed

• 1 other identifier: REB #2018-050
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perimenopausal Depression; Depressive Symptoms

Keywords

Mindfulness based stress reduction; Perimenopausal depression; Menopause transition

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms

  Mean score on the Center for Epidemiologic Studies Depression Scale (CES-D), which assesses depressive symptoms. Total scores can range from 0 to 60, with a higher score indicating more severe symptoms.

  6 months (CES-D completed every 2 weeks)

Secondary Outcomes (3)

• Occurrence of elevated depressive symptoms (ordinal)

  6 months (CES-D completed every 2 weeks)

• Occurrence of elevated depressive symptoms (binary)

  6 months (CES-D completed every 2 weeks)

• Occurrence of major depressive episodes

  6 months (SCID is administered in instances where a score of 16 or above is obtained on the Center for Epidemiologic Studies Depression Scale)

Other Outcomes (3)

• Perceived stress

  6 months (PSS is completed at months 0, 2, 4 and 6)

• Stress resilience

  6 months (completed at months 0, 2, 4 and 6)

• Trait Anxiety

  6 months (completed at months 0, 2, 4 and 6)

Study Arms (2)

Active Treatment

EXPERIMENTAL

Mindfulness-based stress reduction

Behavioral: Mindfulness-based stress reduction

Waitlist control

NO INTERVENTION

The active treatment will be received only after the outcomes monitoring period is complete.

Interventions

Mindfulness-based stress reduction BEHAVIORAL

8 weekly 2.5-hour group sessions of mindfulness based stress reduction, led by a certified MBSR instructor

Active Treatment

Eligibility Criteria

• Age: 42 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• in the early or late menopause transition according to the Stages of Reproductive Aging Workshop (STRAW+10) criteria, defined as menstrual cycle length 7+ days shorter or longer than usual or the presence of amenorrhea lasting 60 days or more (but less than 12 months)

You may not qualify if:

• current psychiatric diagnosis of major depressive disorder, bipolar disorder, a psychotic disorder or any other psychiatric diagnosis rated "severe" based on DSM-5 criteria
• use of medications affecting mood (e.g. antidepressants) or ovarian hormone levels (e.g. oral contraceptives)
• pregnant or nursing
• currently receiving a psychological treatment for depression
• major life-threatening health conditions.

Sponsors & Collaborators

• University of Regina: lead
• Saskatchewan Health Research Foundation: collaborator
• Saskatchewan Centre for Patient-Oriented Research: collaborator
• University of Calgary: collaborator
• Saskatchewan Health Authority - Regina Area: collaborator

Study Sites (1)

University of Regina, Department of Psychology

Regina, Saskatchewan, S4S0A2, Canada

Location

Related Publications (13)

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  PMID: 7334935 BACKGROUND

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• Bromberger JT, Kravitz HM, Chang YF, Cyranowski JM, Brown C, Matthews KA. Major depression during and after the menopausal transition: Study of Women's Health Across the Nation (SWAN). Psychol Med. 2011 Sep;41(9):1879-88. doi: 10.1017/S003329171100016X. Epub 2011 Feb 9.

  PMID: 21306662 BACKGROUND

• Bromberger JT, Matthews KA, Schott LL, Brockwell S, Avis NE, Kravitz HM, Everson-Rose SA, Gold EB, Sowers M, Randolph JF Jr. Depressive symptoms during the menopausal transition: the Study of Women's Health Across the Nation (SWAN). J Affect Disord. 2007 Nov;103(1-3):267-72. doi: 10.1016/j.jad.2007.01.034. Epub 2007 Feb 28.

  PMID: 17331589 BACKGROUND

• Cohen LS, Soares CN, Vitonis AF, Otto MW, Harlow BL. Risk for new onset of depression during the menopausal transition: the Harvard study of moods and cycles. Arch Gen Psychiatry. 2006 Apr;63(4):385-90. doi: 10.1001/archpsyc.63.4.385.

  PMID: 16585467 BACKGROUND

• Freeman EW, Sammel MD, Liu L, Gracia CR, Nelson DB, Hollander L. Hormones and menopausal status as predictors of depression in women in transition to menopause. Arch Gen Psychiatry. 2004 Jan;61(1):62-70. doi: 10.1001/archpsyc.61.1.62.

  PMID: 14706945 BACKGROUND

• Woods NF, Smith-DiJulio K, Percival DB, Tao EY, Mariella A, Mitchell S. Depressed mood during the menopausal transition and early postmenopause: observations from the Seattle Midlife Women's Health Study. Menopause. 2008 Mar-Apr;15(2):223-232. doi: 10.1097/gme.0b013e3181450fc2.

  PMID: 18176355 BACKGROUND

• Bromberger JT, Kravitz HM, Wei HL, Brown C, Youk AO, Cordal A, Powell LH, Matthews KA. History of depression and women's current health and functioning during midlife. Gen Hosp Psychiatry. 2005 May-Jun;27(3):200-8. doi: 10.1016/j.genhosppsych.2005.01.007.

  PMID: 15882767 BACKGROUND

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  PMID: 19389321 BACKGROUND

• Gordon JL, Eisenlohr-Moul TA, Rubinow DR, Schrubbe L, Girdler SS. Naturally Occurring Changes in Estradiol Concentrations in the Menopause Transition Predict Morning Cortisol and Negative Mood in Perimenopausal Depression. Clin Psychol Sci. 2016 Sep;4(5):919-935. doi: 10.1177/2167702616647924.

  PMID: 27867758 BACKGROUND

• Gordon JL, Rubinow DR, Eisenlohr-Moul TA, Leserman J, Girdler SS. Estradiol variability, stressful life events, and the emergence of depressive symptomatology during the menopausal transition. Menopause. 2016 Mar;23(3):257-66. doi: 10.1097/GME.0000000000000528.

  PMID: 26529616 BACKGROUND

• Freeman EW, Sammel MD, Lin H, Nelson DB. Associations of hormones and menopausal status with depressed mood in women with no history of depression. Arch Gen Psychiatry. 2006 Apr;63(4):375-82. doi: 10.1001/archpsyc.63.4.375.

  PMID: 16585466 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer L Gordon, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The staff member who will be assessing for the presence of major depressive disorder in the follow-up period (in cases where a participant's CES-D score is 16 or greater) will be unaware of the participant's treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: July 5, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)