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

Overview

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+.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Tai Chi and Qigong
    • 50mins x 12 weeks of virtually-delivered group tai chi/qigong
  • Active Comparator: Walking and Stretching
    • 50mins x 12 weeks of virtually-delivered group walking and stretching

Clinical Trial Outcome Measures

Primary Measures

  • Change in Depression
    • Time Frame: Baseline, 12-weeks, 24-weeks
    • 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 Measures

  • Change in Processing Speed
    • Time Frame: Baseline, 12-weeks, 24-weeks
    • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lady Davis Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soham Rej MD, MSc, Geriatric Psychiatrist, Assistant Professor, Principle Investigator – Lady Davis Institute

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.