Clinical trial NCT04450147: Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: mindfulness
older age bipolar disorder
tai chi
qigong
randomized controlled trial
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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+.


Eligibility 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)

Primary outcomes:
measure: Change in Depression
timeFrame: Baseline, 12-weeks, 24-weeks
Secondary outcomes:
measure: Change in Processing Speed
timeFrame: Baseline, 12-weeks, 24-weeks
Other outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 12-weeks, 24-weeks
measure: Change in Daily Functioning
timeFrame: Baseline, 12-weeks, 24-weeks
measure: Change in Generalized Anxiety
timeFrame: Baseline, 12-weeks, 24-weeks
measure: Change in Mindfulness
timeFrame: Baseline, 12-weeks, 24-weeks
measure: Change in Self-Compassion
timeFrame: Baseline, 12-weeks, 24-weeks
measure: Change in Mania
timeFrame: Baseline, 12-weeks, 24-weeks
measure: Change in Self-Reported Depression
timeFrame: Baseline, weekly throughout 12-weeks, 24-weeks
measure: Change in Self-Reported Mania
timeFrame: Baseline, weekly throughout 12-weeks, 24-weeks
Locations:
city: Montréal
country: Canada
facility: Lady Davis Institute
Study officials:
References:
citation: 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.