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

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+.

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder
• Intervention / Treatment: Behavioral: Tai Chi/Qigong vs. Walking/Stretching

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada
    • Recruiting
    • Lady Davis Institute
    • Contact: Haley Park; Phone Number: 514-581-3956; Email: hyeon.park3@mail.mcgill.ca
    • Principal Investigator: Soham Rej

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi and Qigong; 50mins x 12 weeks of virtually-delivered group tai chi/qigong	Behavioral: Tai Chi/Qigong vs. Walking/Stretching; Both interventions can be thought of as a form of movement and exercise.
Active Comparator: Walking and Stretching; 50mins x 12 weeks of virtually-delivered group walking and stretching	Behavioral: Tai Chi/Qigong vs. Walking/Stretching; Both interventions can be thought of as a form of movement and exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Lady Davis Institute

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; mindfulness; tai chi; older age bipolar disorder; qigong
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder
• Other Study ID Numbers: MP-05-2020-1825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No