Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder
Efficacy of Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder: A Pilot Randomized Controlled Trial With an Active Control
1 other identifier
interventional
23
1 country
1
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+.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
November 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMay 25, 2025
November 1, 2020
3 months
March 3, 2020
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Depression
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
Baseline, 12-weeks, 24-weeks
Secondary Outcomes (1)
Change in Processing Speed
Baseline, 12-weeks, 24-weeks
Other Outcomes (8)
Change in Quality of Life
Baseline, 12-weeks, 24-weeks
Change in Daily Functioning
Baseline, 12-weeks, 24-weeks
Change in Generalized Anxiety
Baseline, 12-weeks, 24-weeks
- +5 more other outcomes
Study Arms (2)
Tai Chi and Qigong
EXPERIMENTAL50mins x 12 weeks of virtually-delivered group tai chi/qigong
Walking and Stretching
ACTIVE COMPARATOR50mins x 12 weeks of virtually-delivered group walking and stretching
Interventions
Both interventions can be thought of as a form of movement and exercise.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lady Davis Institute
Montreal, Canada
Related Publications (1)
Sajatovic M, Eyler LT, Rej S, Almeida OP, Blumberg HP, Forester BP, Forlenza OV, Gildengers A, Mulsant BH, Strejilevich S, Tsai S, Vieta E, Young RC, Dols A. The Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE-BD) project: Understanding older-age bipolar disorder by combining multiple datasets. Bipolar Disord. 2019 Nov;21(7):642-649. doi: 10.1111/bdi.12795. Epub 2019 May 30.
PMID: 31081573BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Geriatric Psychiatrist, Assistant Professor, Principle Investigator
Study Record Dates
First Submitted
March 3, 2020
First Posted
June 29, 2020
Study Start
November 10, 2020
Primary Completion
February 1, 2021
Study Completion
May 1, 2021
Last Updated
May 25, 2025
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.