Clinical trial NCT06275217: Mindful Yoga for Postpartum Depression
Official title: The Effects of a Mindful Yoga Program on Mood Symptoms and Stress for Postpartum Women With Depressive Symptoms: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorders
Keywords: Yoga
Mindfulness-based
Postpartum depression
mood symptoms
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months.


Eligibility criteria: Inclusion Criteria:

* Postpartum women aged 18-60 years old.
* The scores of EPDS ≥ 10.
* At least 6 week and up to 1 year after childbirth.
* Giving birth to a single full-term healthy baby (gestation between 37-41 weeks, body weight \> 2.5kg, APGAR score at 5 minutes \> 7).
* Fewer than 10 hours of yoga/Qi gong/Tai Chi or mindfulness/meditation practice in the previous 3 months.

Exclusion Criteria:

* Severe complications after delivery, or their infants are admitted to NICU.
* Regular psychiatric follow-up.
* Currently taking antipsychotic drugs.
* Known pragnancy, or other contraindications to physical exercise (e.g., wound healing situation) according to the body examination by O\&G clinicians at 6 weeks after delivery.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary outcomes:
measure: Depression Anxiety Stress Scale-Depression
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: Depression Anxiety Stress Scale-Anxiety
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: Depression Anxiety Stress Scale-Stress
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: 36 Item-Short Form Health Survey Questionnaire
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: Pregnancy Symptom Inventory
timeFrame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
measure: Cortisol concentration level
timeFrame: Baseline and 10 weeks (post-intervention).
measure: Physical fitness
timeFrame: Baseline and 10 weeks (post-intervention).
measure: Balance
timeFrame: Baseline and 10 weeks (post-intervention).
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: Jessie Lin, PhD
role: STUDY_CHAIR
References: