Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tai Chi/Qigong vs. Walking/Stretching
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring mindfulness, older age bipolar disorder, tai chi, qigong, randomized controlled trial
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)
Sites / Locations
- Lady Davis InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tai Chi and Qigong
Walking and Stretching
Arm Description
50mins x 12 weeks of virtually-delivered group tai chi/qigong
50mins x 12 weeks of virtually-delivered group walking and stretching
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04450147
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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+.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
mindfulness, older age bipolar disorder, tai chi, qigong, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi and Qigong
Arm Type
Experimental
Arm Description
50mins x 12 weeks of virtually-delivered group tai chi/qigong
Arm Title
Walking and Stretching
Arm Type
Active Comparator
Arm Description
50mins x 12 weeks of virtually-delivered group walking and stretching
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi/Qigong vs. Walking/Stretching
Intervention Description
Both interventions can be thought of as a form of movement and exercise.
Primary Outcome Measure Information:
Title
Change in Depression
Description
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 Outcome Measure Information:
Title
Change in Processing Speed
Description
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 Pre-specified Outcome Measures:
Title
Change in Quality of Life
Description
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
Title
Change in Daily Functioning
Description
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
Title
Change in Generalized Anxiety
Description
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
Title
Change in Mindfulness
Description
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
Title
Change in Self-Compassion
Description
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
Title
Change in Mania
Description
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
Title
Change in Self-Reported Depression
Description
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
Title
Change in Self-Reported Mania
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Lady Davis Institute
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Park
Phone
514-581-3956
Email
hyeon.park3@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Soham Rej
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available June 2021 (anticipated), and will be kept at GAGE-BD indefinitely.
IPD Sharing Access Criteria
All researcher-users involved in GAGE-BD agree not to communicate or transfer data to anyone. They agree not to use the data for a research study that is not approved by the GAGE-BD management or a Research Ethics Board.
Citations:
PubMed Identifier
31081573
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/31081573
Description
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Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder
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