Antenatal Yoga Intervention for Depressed and Anxious Women

NCT05299190 | Withdrawn

• 1 other identifier: HMontfort
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale

  measure of depressive symptoms

  Baseline; week 4; week 8; bimonthly until 6 months postpartium

Secondary Outcomes (7)

• Perceived Stress Scale

  Baseline; Week 8; bimonthly until 6-months postpartum;

• Interpersonal Relationships Inventory (interpersonal support subscale)

  Baseline; Week 8; 6-months post-partum

• Dyadic Adjustment Scale

  Baseline; Week 8; 6-months post-partum

• Five Facet Mindfulness Scale

  Baseline; Week 8; 6-months post-partum

• Self-Compassion Scale

  Baseline; Week 8; 6-months post-partum

Other Outcomes (3)

• Feasibility outcomes

  Week 1 to 8

• Pregnancy outcomes

  Baseline and week 8 and post-partum

• Stress hormones

  Baseline and week 8 for mother and 8-weeks and 6-months for infant

Study Arms (2)

Yoga intervention plus TAU

EXPERIMENTAL

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

Clinical Monitoring plus TAU

OTHER

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

Interventions

Yoga intervention plus TAU OTHER

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

Yoga intervention plus TAU

Clinical Monitoring plus TAU OTHER

clinical monitoring includes bi-weekly 15-20 minute telephone contact with participants. TAU is usual care participants receive from their health care provider.

Clinical Monitoring plus TAU

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Hopital Montfort: lead

Study Officials

• Diana Koszycki, PhD

  Institut du Savoir Montfort

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The MINI will be administered at 6-months post-partum by a blind assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoring

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 28, 2022
• Study Start: March 1, 2020
• Primary Completion: August 24, 2021
• Study Completion: December 30, 2021
• Last Updated: March 28, 2022

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share