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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04450147
• Other study ID #: MP-05-2020-1825
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: May 2021

Study information

• Verified date: November 2020
• Source: Lady Davis Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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+.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Behavioral:
• Tai Chi/Qigong vs. Walking/Stretching
Both interventions can be thought of as a form of movement and exercise.

Locations

Country	Name	City	State
Canada	Lady Davis Institute	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline, 12-weeks, 24-weeks
Other	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	Baseline, 12-weeks, 24-weeks
Other	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	Baseline, 12-weeks, 24-weeks
Other	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	Baseline, 12-weeks, 24-weeks
Other	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	Baseline, 12-weeks, 24-weeks
Other	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	Baseline, 12-weeks, 24-weeks
Other	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	Baseline, weekly throughout 12-weeks, 24-weeks
Other	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	Baseline, weekly throughout 12-weeks, 24-weeks
Primary	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	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.	Baseline, 12-weeks, 24-weeks

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