Clinical trial NCT05299190: Antenatal Yoga Intervention for Depressed and Anxious Women
Official title: Feasibility, Acceptability and Preliminary Efficacy of a Hospital-based Antenatal Yoga Program for Anxious and Depressed Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety Depression
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoring
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if a hospital-based antenatal yoga program (HB-AYP) is a feasible, acceptable and potentially efficacious intervention for women with antenatal anxiety and/or depression?

Detailed description: Anxiety and depression are the most common psychological symptoms reported in pregnant women and can result in adverse obstetric, neonatal and post-partum mental health outcomes. Although there is a range of effective first-line treatments for anxiety and depression, these treatments are not without limitations. Concerns about the safety of antidepressant medication during pregnancy, lack of access to affordable psychosocial treatments and reluctance to seek mental health care due to stigma may prevent pregnant women from receiving optimal care for their symptoms. Recently, there has been growing interest in alternative and complementary approaches to manage anxiety and depression. These approaches may offer women with antenatal anxiety and depression an alternative treatment option that may be more acceptable and perceived as more holistic and less stigmatizing than conventional mental health care. One way to optimize access to yoga therapy during prenatal care is to implement an antenatal yoga program within a public healthcare system. Accordingly, the overarching aim of this study is to evaluate the feasibility of a hospital-based antenatal yoga program (HB-AYP) plus treatment as usual for anxiety and depression, and obtain preliminary data on its potential efficacy relative to treatment as usual plus biweekly clinical monitoring(TAU) This pilot research will provide much needed preliminary data that will set the foundation for designing a fully-powered prospective randomized controlled trial (RCT) of a HB-AYP. In the long term, it is hoped that this line of research will influence evidence-based clinical guidelines for managing antenatal anxiety and depression and service delivery.

Eligibility criteria: Inclusion Criteria: Healthy women in their second trimester of an uncomplicated pregnancy with elevated levels of anxiety and/or depression (based on the PHQ-9 and GAD-7) will be eligible to participate

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Exclusion Criteria: i) a lifetime history of psychosis, ii) symptoms of mania/hypomania in the past 12 months; iii) a history of substance use disorders in the last 6 months; iv) a history of self-harm in the last 6 months; v) high suicide risk; vi) engaged in a regular formal meditative practice at least once a month over the past 12 months; and vii) yoga postures are contraindicated.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: Baseline; week 4; week 8; bimonthly until 6 months postpartium
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline; Week 8; bimonthly until 6-months postpartum;
measure: Interpersonal Relationships Inventory (interpersonal support subscale)
timeFrame: Baseline; Week 8; 6-months post-partum
measure: Dyadic Adjustment Scale
timeFrame: Baseline; Week 8; 6-months post-partum
measure: Five Facet Mindfulness Scale
timeFrame: Baseline; Week 8; 6-months post-partum
measure: Self-Compassion Scale
timeFrame: Baseline; Week 8; 6-months post-partum
measure: Prenatal Attachment Inventory
timeFrame: Baseline; Week 8
measure: Post-partum bonding questionnaire
timeFrame: 6-months postpartum
Other outcomes:
measure: Feasibility outcomes
timeFrame: Week 1 to 8
measure: Pregnancy outcomes
timeFrame: Baseline and week 8 and post-partum
measure: Stress hormones
timeFrame: Baseline and week 8 for mother and 8-weeks and 6-months for infant
Locations:
Study officials:
affiliation: Institut du Savoir Montfort
name: Diana Koszycki, PhD
role: PRINCIPAL_INVESTIGATOR
References: