Antenatal Yoga Intervention for Depressed and Anxious Women

NCT ID: NCT05299190

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-12-30

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.

Conditions

Anxiety Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoga intervention plus TAU

Intervention Type: 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

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.

Group Type: OTHER

Clinical Monitoring plus TAU

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hopital Montfort

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Koszycki, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut du Savoir Montfort

Other Identifiers

HMontfort

Identifier Type: -

Identifier Source: org_study_id