Antenatal Yoga Intervention for Depressed and Anxious Women
- Conditions
- Anxiety Depression
- Interventions
- Other: Clinical Monitoring plus TAUOther: Yoga intervention plus TAU
- Registration Number
- NCT05299190
- Lead Sponsor
- Hopital Montfort
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical Monitoring plus TAU Clinical Monitoring plus TAU Clinical monitoring will be conducted by telephone and include a 15-20 minutes discussions of how the participant has been feeling over the past two weeks. A standard format will be used for conducting the clinical monitoring telephone calls. TAU will include treatment based on the recommendation of participants' healthcare provider/team. Yoga intervention plus TAU Yoga intervention plus TAU Participants randomized to the yoga intervention will attend 8-weekly 90-minute group sessions. The intervention will be delivered by certified instructors with experience facilitating yoga classes for pregnant women. Monthly "drop-in" classes will be scheduled in order to motivate women to maintain their practice during the follow-up period. The yoga intervention will be based on the hatha yoga system modified for pregnancy. TAU will include treatment based on the recommendation of participants' healthcare provider/team.
- Primary Outcome Measures
Name Time Method Edinburgh Postnatal Depression Scale Baseline; week 4; week 8; bimonthly until 6 months postpartium measure of depressive symptoms
- Secondary Outcome Measures
Name Time Method Dyadic Adjustment Scale Baseline; Week 8; 6-months post-partum Measure of marital adjustment
Five Facet Mindfulness Scale Baseline; Week 8; 6-months post-partum Measure of facets of mindfulness
Perceived Stress Scale Baseline; Week 8; bimonthly until 6-months postpartum; measure of stress
Self-Compassion Scale Baseline; Week 8; 6-months post-partum Measure of self-compassion
Prenatal Attachment Inventory Baseline; Week 8 Measure of prenatal attachment
Post-partum bonding questionnaire 6-months postpartum Measure of post-partum bonding
Interpersonal Relationships Inventory (interpersonal support subscale) Baseline; Week 8; 6-months post-partum Measure of interpersonal support