Antenatal Yoga Intervention for Depressed and Anxious Women

Anxiety Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05299190
• Other study ID #: HMontfort
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2019
• Source: Hopital Montfort
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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 - 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.

Related Conditions & MeSH terms

• Anxiety Depression
• Depression

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Montfort

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility outcomes	Ease of recruitment; study compliance, program satisfaction; perception of treatment credibility	Week 1 to 8
Other	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
Other	Stress hormones	Salivary cortisol and alpha amylase	Baseline and week 8 for mother and 8-weeks and 6-months for infant
Primary	Edinburgh Postnatal Depression Scale	measure of depressive symptoms	Baseline; week 4; week 8; bimonthly until 6 months postpartium
Secondary	Perceived Stress Scale	measure of stress	Baseline; Week 8; bimonthly until 6-months postpartum;
Secondary	Interpersonal Relationships Inventory (interpersonal support subscale)	Measure of interpersonal support	Baseline; Week 8; 6-months post-partum
Secondary	Dyadic Adjustment Scale	Measure of marital adjustment	Baseline; Week 8; 6-months post-partum
Secondary	Five Facet Mindfulness Scale	Measure of facets of mindfulness	Baseline; Week 8; 6-months post-partum
Secondary	Self-Compassion Scale	Measure of self-compassion	Baseline; Week 8; 6-months post-partum
Secondary	Prenatal Attachment Inventory	Measure of prenatal attachment	Baseline; Week 8
Secondary	Post-partum bonding questionnaire	Measure of post-partum bonding	6-months postpartum