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Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT04450147
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Soham Rej MD, MSc, Lady Davis Institute

Study Description
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Brief Summary:
It is expected that by 2030, the percentage of patients with bipolar disorder (BD) in Canada over 60 years of age will exceed 50%. In this population, poor cognition and persistent sub-threshold depressive symptoms are particularly common, difficult to treat, associated with increased mood episodes, and poor daily functioning. Mind-body interventions have increasingly been found to be effective in treating several psychiatric condition including BD. A few pilot studies examining mindfulness-based intervention in younger adult BD have been promising for depressive symptoms, but some pilot research suggest that patients with older age bipolar disorder (OABD) may benefit more from moving mindfulness. The investigators will conduct a 12-week randomized controlled trial to assess whether tai-chi/qigong will be associated with 1) greater reduction in depressive symptoms, and 2) greater improved cognition, in comparison to a light exercise active control condition, 12- and 24-weeks from baseline, in BD patients aged 40+.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Tai Chi/Qigong vs. Walking/Stretching Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder: A Pilot Randomized Controlled Trial With an Active Control
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tai Chi and Qigong
50mins x 12 weeks of virtually-delivered group tai chi/qigong
 Behavioral: Tai Chi/Qigong vs. Walking/Stretching
Both interventions can be thought of as a form of movement and exercise.
Active Comparator: Walking and Stretching
50mins x 12 weeks of virtually-delivered group walking and stretching
 Behavioral: Tai Chi/Qigong vs. Walking/Stretching
Both interventions can be thought of as a form of movement and exercise.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Depression [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Level of depression as measured by the Montgomery-Asberg Depression Rating Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome


Secondary Outcome Measures :
  1. Change in Processing Speed [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Processing speed as measured by the Animal Fluency Test at 12-weeks and 24-weeks. Scored by number of animals named, higher score indicates better outcome.


Other Outcome Measures:
  1. Change in Quality of Life [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Quality of life as measured by the Quality of Life in Bipolar Disorder Questionnaire - Short Form, at 12-weeks and 24-weeks post-intervention. Possible score range: 12-60, higher score indicates worse outcome

  2. Change in Daily Functioning [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Daily functioning as measured by the Functional Assessment Short Test, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-72, higher score indicates worse outcome

  3. Change in Generalized Anxiety [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Generalized anxiety as measured by the Generalized Anxiety Disorder 7-item scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-21, higher score indicates worse outcome

  4. Change in Mindfulness [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Mindfulness as measured by the Five Factor Mindfulness Questionnaire Short Form at 12-weeks and 24-weeks post-intervention. Possible score range = 49-110, higher score indicates worse outcome

  5. Change in Self-Compassion [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Self-compassion as measured by the Self Compassion Scale Short Form at 12-weeks and 24-weeks post-intervention. Possible score range: 0-130, higher score indicates worse outcome

  6. Change in Mania [ Time Frame: Baseline, 12-weeks, 24-weeks ]
    Mania as measured by the Young Mania Rating Scale at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome

  7. Change in Self-Reported Depression [ Time Frame: Baseline, weekly throughout 12-weeks, 24-weeks ]
    Level of depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-45, higher score indicates worse outcome

  8. Change in Self-Reported Mania [ Time Frame: Baseline, weekly throughout 12-weeks, 24-weeks ]
    Level of mania as measured by the Altman Self-Rating Mania Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-25, higher score indicates worse outcome


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged greater than or equal to 40 years
  • history of diagnosis of bipolar I or II disorder
  • access to a computer with a functioning camera, microphone, and ability to run Zoom software
  • English or French speaking
  • ability to give informed consent

Exclusion Criteria:

  • Young Mania Rating Scale score > 5
  • current clinician diagnosis of substance abuse, unless currently in complete remission
  • risk of suicide as assessed by a score above 3 on item 10 of Montgomery Asberg Depression Rating Scale
  • participation or plan to participate in any other concurrent psychosocial group program during course of study
  • unstable psychiatric medication (less than 4-weeks since commencement)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04450147


Locations
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Canada
Lady Davis Institute Recruiting
Montréal, Canada
Contact: Haley Park    514-581-3956    hyeon.park3@mail.mcgill.ca   
Principal Investigator: Soham Rej         
Sponsors and Collaborators
Lady Davis Institute
More Information
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Additional Information:

Publications:

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Responsible Party: Soham Rej MD, MSc, Geriatric Psychiatrist, Assistant Professor, Principle Investigator, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT04450147    
Other Study ID Numbers: MP-05-2020-1825
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from the study will be sent to the Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE-BD). The objective of GAGE-BD is to gather data from research studies about older adults (age 50+) with bipolar disorder to allow researchers from the Douglas Institute, or other researchers, in Canada, the United States and around the world, to use the database for future research projects exploring possible relationships between age, medical conditions and bipolar symptoms. Following completion of data collection, the data including all outcomes and demographic and health information, anonymized and free of any identifying or personal information, will be sent to Dr. Betsy Wilson (more info on Dr. Wilson further below) via Box (https://case.edu/utech/help/knowledge-base/box/box-information), a secure cloud storage service managed by Case Western University.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data will be available June 2021 (anticipated), and will be kept at GAGE-BD indefinitely.
Access Criteria: All researcher-users involved in GAGE-BD agree not to communicate or transfer data to anyone. They agree not to use the data for a research study that is not approved by the GAGE-BD management or a Research Ethics Board.

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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 Soham Rej MD, MSc, Lady Davis Institute:
mindfulness
older age bipolar disorder
tai chi
qigong
randomized controlled trial
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders