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CompletedNCT04450147Updated May 25, 2025

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

An interventional study of Tai Chi/Qigong vs. Walking/Stretching in Bipolar Disorder, sponsored by Lady Davis Institute. Completed at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Lady Davis Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
40 Years and older
Sex
All
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Study 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+.

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Conditions studied

  • Bipolar Disorder

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Keywords

  • mindfulness
  • older age bipolar disorder
  • tai chi
  • qigong
  • randomized controlled trial
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In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 23 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Lady Davis Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Tai Chi and Qigong

    50mins x 12 weeks of virtually-delivered group tai chi/qigong

    Behavioral: Tai Chi/Qigong vs. Walking/Stretching

  • Active comparator
    Walking and Stretching

    50mins x 12 weeks of virtually-delivered group walking and stretching

    Behavioral: Tai Chi/Qigong vs. Walking/Stretching

Interventions

  • BehavioralTai Chi/Qigong vs. Walking/Stretching

    Both interventions can be thought of as a form of movement and exercise.

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What researchers measure

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

    Time frame: Baseline, 12-weeks, 24-weeks

Secondary outcomes

  1. Change in Processing Speed

    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.

    Time frame: Baseline, 12-weeks, 24-weeks

Other outcomes

  1. Change in Quality of Life

    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

    Time frame: Baseline, 12-weeks, 24-weeks

  2. Change in Daily Functioning

    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

    Time frame: Baseline, 12-weeks, 24-weeks

  3. Change in Generalized Anxiety

    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

    Time frame: Baseline, 12-weeks, 24-weeks

  4. Change in Mindfulness

    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

    Time frame: Baseline, 12-weeks, 24-weeks

  5. Change in Self-Compassion

    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

    Time frame: Baseline, 12-weeks, 24-weeks

  6. Change in Mania

    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

    Time frame: Baseline, 12-weeks, 24-weeks

  7. Change in Self-Reported Depression

    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

    Time frame: Baseline, weekly throughout 12-weeks, 24-weeks

  8. Change in Self-Reported Mania

    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

    Time frame: Baseline, weekly throughout 12-weeks, 24-weeks

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Study locations

1 site
  • Lady Davis Institute
    Montréal, Canada
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References and documents

Publications

  • 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. PubMed 31081573 ↗

Related links

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Sap, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04450147
Lead sponsor
Lady Davis Institute
Responsible party
Soham Rej MD, MSc (Geriatric Psychiatrist, Assistant Professor, Principle Investigator, Lady Davis Institute) — Principal investigator
First posted
Jun 29, 2020
Start date
Nov 10, 2020
Primary completion
Feb 1, 2021
Completion
May 1, 2021
Last update
May 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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