Clinical trial NCT05482646: Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs
Official title: Tai Chi Versus Conventional Exercise to Alleviate Depressive Symptoms in Older Insomniacs: A Three-arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Chronic Insomnia
Keywords: Exercise
Tai Chi
Elderly
Depression
Insomnia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 420
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.

Detailed description: Chinese community-dwelling older adults with mild-to-moderate depressive symptoms and chronic insomnia will be recruited.

Eligible participants will be randomized to health education control, Tai Chi or conventional exercise interventions on a 1:1:1 basis after baseline assessment.

All interventions will last for 3 months. Outcomes will be assessed at baseline, at 3 months and at 6 months after the completion of the intervention.

Eligibility criteria: Inclusion Criteria:

* 60 years or older
* Can communicate using Cantonese or Mandarin
* with mild-to-moderate depressive symptoms (HADS-depression score ≥8/21 and PHQ- 9 score ≤14/27)
* Fulfil the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for chronic insomnia including difficulties in initiating or maintaining sleep, early morning awakening with complaint of significant distress or impairment of daytime functioning, sleep difficulty occurring at least three nights per week and present for at least 3 months.

Exclusion Criteria:

* Somatic condition that prevents participation in tai chi or exercise
* Regular moderate-to-vigorous intensity exercise or mind-body training such as tai chi, yoga, qigong or meditation in the past 3 months
* Any form (or combination) of exercises amounting to 180 minutes per week in the past 3 months
* Dementia
* Diagnosis with schizophrenia or other psychotic disorders, bipolar disorders or alcohol/substance use/abuse
* Current usage or planning to use potentially confounding treatments, including herbal supplementations (e.g., St. John's Wort), acupuncture treatment, cognitive behavioral therapy or other psychotherapy, mind-body intervention (e.g., mindfulness training and muscle relaxation training) or muscle relaxants such as carisoprodol, cyclobenzaprine, diazepam
* Current suicidal or self-injurious potential that requires immediate clinical follow-up.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale - Depression
timeFrame: 3 months (post-intervention)
measure: Hospital Anxiety and Depression Scale - Depression
timeFrame: 9 months (6 months post-intervention follow-up)
Secondary outcomes:
measure: Insomnia severity index
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Pittsburgh Sleep Quality Index
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Patient Health Questionnaire
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: General Anxiety Disorder Scale
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Hospital Anxiety and Depression Scale - Anxiety
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Medication usage
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: The 12-item Short Form Survey
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Short Physical Performance Battery
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Sleep efficiency through actigraph
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Sleep efficiency through sleep diary
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Wake time after sleep onset through actigraph
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Wake time after sleep onset through sleep diary
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Number of awakenings through actigraph
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Number of awakenings through sleep diary
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Sleep onset latency through actigraph
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Sleep onset latency through sleep diary
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Average awake time through actigraph
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Average awake time through sleep diary
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Total sleep time through actigraph
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
measure: Total sleep time through sleep diary
timeFrame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: LKS Faculty of Medicine, HKU
Study officials:
affiliation: The University of Hong Kong
name: Parco M Siu, PhD
role: PRINCIPAL_INVESTIGATOR
References: