Bipolar DisorderNCT04450147
Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder
A study testing Tai Chi/Qigong vs. Walking/Stretching in people with Bipolar Disorder, run by Lady Davis Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Tai Chi/Qigong vs. Walking/Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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+.
- Conditions
- Bipolar Disorder
- Being tested
- Tai Chi/Qigong vs. Walking/Stretching
- Keywords
- mindfulness, older age bipolar disorder, tai chi, qigong, randomized controlled trial
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi/Qigong vs. Walking/StretchingBehavioural
Both interventions can be thought of as a form of movement and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi and Qigong | Experimental | 50mins x 12 weeks of virtually-delivered group tai chi/qigong Receives: Behavioral: Tai Chi/Qigong vs. Walking/Stretching |
| Walking and Stretching | Active comparator | 50mins x 12 weeks of virtually-delivered group walking and stretching Receives: Behavioral: Tai Chi/Qigong vs. Walking/Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, 12-weeks, 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start10 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soham Rej MD, MSc, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450147
- Sponsor's protocol ID
- MP-05-2020-1825
- Status last verified
- Nov 2020
- First submitted
- 3 Mar 2020
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04450147
- Acronym / sponsor ID
- MP-05-2020-1825
- Conditions
- Bipolar Disorder
- Keywords
- mindfulness, older age bipolar disorder, tai chi, qigong, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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+.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi and Qigong | Experimental | Behavioral: Tai Chi/Qigong vs. Walking/Stretching50mins x 12 weeks of virtually-delivered group tai chi/qigong |
| Walking and Stretching | Active comparator | Behavioral: Tai Chi/Qigong vs. Walking/Stretching50mins x 12 weeks of virtually-delivered group walking and stretching |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi/Qigong vs. Walking/StretchingBoth interventions can be thought of as a form of movement and exercise. | Behavioural | Tai Chi and Qigong, Walking and Stretching |
Primary outcome
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
1 secondary outcome
Change in Processing Speed
Time frame: Baseline, 12-weeks, 24-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 31081573Sajatovic 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi/Qigong vs. Walking/Stretching in people with Bipolar Disorder, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression (time frame: Baseline, 12-weeks, 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.