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Trial record 10 of 2663 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

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

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ClinicalTrials.gov Identifier: NCT03526523
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Saskatchewan Health Research Foundation
Saskatchewan Center for Patient-Oriented Research
University of Calgary
Saskatchewan Health Authority - Regina Area
Information provided by (Responsible Party):
University of Regina

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.

Condition or disease Intervention/treatment Phase
Perimenopausal Depression Depressive Symptoms Behavioral: Mindfulness-based stress reduction Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Testing the Efficacy of Mindfulness-based Stress Reduction as a Prophylactic Intervention in the Prevention of Perimenopausal Depression: a Randomized Trial
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Treatment
Mindfulness-based stress reduction
Behavioral: Mindfulness-based stress reduction
8 weekly 2.5-hour group sessions of mindfulness based stress reduction, led by a certified MBSR instructor

No Intervention: Waitlist control
The active treatment will be received only after the outcomes monitoring period is complete.



Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 6 months (CES-D completed every 2 weeks) ]
    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.


Secondary Outcome Measures :
  1. Occurrence of elevated depressive symptoms (ordinal) [ Time Frame: 6 months (CES-D completed every 2 weeks) ]
    Number of times a participant obtains a score of 16 or above 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.

  2. Occurrence of elevated depressive symptoms (binary) [ Time Frame: 6 months (CES-D completed every 2 weeks) ]
    Whether or not a participant obtains a score of 16 or above on the Center for Epidemiologic Studies Depression Scale (CES-D) at least once. The CES-D assesses depressive symptoms. Total scores can range from 0 to 60, with a higher score indicating more severe symptoms.

  3. Occurrence of major depressive episodes [ Time Frame: 6 months (SCID is administered in instances where a score of 16 or above is obtained on the Center for Epidemiologic Studies Depression Scale) ]
    Whether or not a participant meets all 5 criteria for a major depressive episode according to the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5).


Other Outcome Measures:
  1. Perceived stress [ Time Frame: 6 months (PSS is completed at months 0, 2, 4 and 6) ]
    Mean score on the Perceived Stress Scale (PSS). Scores range from 0 to 40, with higher scores indicating greater perceived stress.

  2. Stress resilience [ Time Frame: 6 months (completed at months 0, 2, 4 and 6) ]
    Mean score on the Connor-Davidson Resilience Scale, which assesses resilience to stress. Scores range from 0 to 100, with higher scores indicating greater resilience.

  3. Trait Anxiety [ Time Frame: 6 months (completed at months 0, 2, 4 and 6) ]
    Mean score on Form Y of the State-Trait Anxiety Inventory, which assesses trait anxiety. Scores range from 20 to 80, with higher scores indicating greater anxiety.



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Ages Eligible for Study:   42 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526523


Contacts
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Contact: Jennifer L Gordon, PhD 306-585-4389 jennifer.gordon@uregina.ca
Contact: Tianna Sauer, BSc 306-585-4992 wmh.research@uregina.ca

Locations
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Canada, Saskatchewan
University of Regina, Department of Psychology Recruiting
Regina, Saskatchewan, Canada, S4S0A2
Contact: Tianna Sauer, BSc    306-585-4992    wmh.research@uregina.ca   
Contact: Jennifer L Gordon, PhD    306-585-4389    jennifer.gordon@uregina.ca   
Sponsors and Collaborators
University of Regina
Saskatchewan Health Research Foundation
Saskatchewan Center for Patient-Oriented Research
University of Calgary
Saskatchewan Health Authority - Regina Area
Investigators
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Principal Investigator: Jennifer L Gordon, PhD University of Regina

Publications:

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Responsible Party: University of Regina
ClinicalTrials.gov Identifier: NCT03526523     History of Changes
Other Study ID Numbers: REB #2018-050
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Regina:
Mindfulness based stress reduction
Perimenopausal depression
Menopause transition

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders