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Completed

NCT Number: NCT04450147

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

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+.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Davis Institute

Montreal, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tai Chi/Qigong vs. Walking/Stretching

Behavioral

Both interventions can be thought of as a form of movement and exercise.

Primary outcomes

  1. 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 outcomes

  1. 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.

Other outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 12-weeks, 24-weeks

    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

  2. Change in Daily Functioning

    Time frame: Baseline, 12-weeks, 24-weeks

    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

  3. Change in Generalized Anxiety

    Time frame: Baseline, 12-weeks, 24-weeks

    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

  4. Change in Mindfulness

    Time frame: Baseline, 12-weeks, 24-weeks

    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

  5. Change in Self-Compassion

    Time frame: Baseline, 12-weeks, 24-weeks

    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

  6. Change in Mania

    Time frame: Baseline, 12-weeks, 24-weeks

    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

  7. Change in Self-Reported Depression

    Time frame: Baseline, weekly throughout 12-weeks, 24-weeks

    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

  8. Change in Self-Reported Mania

    Time frame: Baseline, weekly throughout 12-weeks, 24-weeks

    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

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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