Antenatal Yoga Intervention for Depressed and Anxious Women

Feasibility, Acceptability and Preliminary Efficacy of a Hospital-based Antenatal Yoga Program for Anxious and Depressed Women

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?

Study Overview

• Status: Withdrawn
• Conditions: Anxiety Depression
• Intervention / Treatment: Other: Yoga intervention plus TAU; Other: Clinical Monitoring plus TAU

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Yoga intervention plus TAU; The yoga intervention consists of 8 weekly group sessions. The intervention is based on hatha yoga system. TAU is usual care participants receive from their health care provider
Other: 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.	Other: Clinical Monitoring plus TAU; clinical monitoring includes bi-weekly 15-20 minute telephone contact with participants. TAU is usual care participants receive from their health care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale	measure of depressive symptoms	Baseline; week 4; week 8; bimonthly until 6 months postpartium

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	measure of stress	Baseline; Week 8; bimonthly until 6-months postpartum;
Interpersonal Relationships Inventory (interpersonal support subscale)	Measure of interpersonal support	Baseline; Week 8; 6-months post-partum
Dyadic Adjustment Scale	Measure of marital adjustment	Baseline; Week 8; 6-months post-partum
Five Facet Mindfulness Scale	Measure of facets of mindfulness	Baseline; Week 8; 6-months post-partum
Self-Compassion Scale	Measure of self-compassion	Baseline; Week 8; 6-months post-partum
Prenatal Attachment Inventory	Measure of prenatal attachment	Baseline; Week 8
Post-partum bonding questionnaire	Measure of post-partum bonding	6-months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility outcomes	Ease of recruitment; study compliance, program satisfaction; perception of treatment credibility	Week 1 to 8
Pregnancy outcomes	Presence of gestational diabetes and hypertension; gestational age at delivery, mode of delivery, pregnancy and birth complications, infant birth weight; Apgar scores	Baseline and week 8 and post-partum
Stress hormones	Salivary cortisol and alpha amylase	Baseline and week 8 for mother and 8-weeks and 6-months for infant

Collaborators and Investigators

• Sponsor: Hopital Montfort
• Investigators: Principal Investigator: Diana Koszycki, PhD, Institut du Savoir Montfort

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): August 24, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: HMontfort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No