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
Verified date | November 2020 |
Source | Lady Davis Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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+.
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Lady Davis Institute | Montréal |
Lead Sponsor | Collaborator |
---|---|
Lady Davis Institute |
Canada,
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
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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