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Clinical Trials/NCT05299190
NCT05299190WithdrawnNot Applicable

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

Hopital Montfort0 sitesStarted: March 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Edinburgh Postnatal Depression Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The MINI will be administered at 6-months post-partum by a blind assessor

Eligibility Criteria

Ages
16 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Yoga intervention plus TAU (Other)

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.

Intervention: Clinical Monitoring plus TAU (Other)

Outcomes

Primary Outcomes

Edinburgh Postnatal Depression Scale

Time Frame: Baseline; week 4; week 8; bimonthly until 6 months postpartium

measure of depressive symptoms

Secondary Outcomes

  • Five Facet Mindfulness Scale(Baseline; Week 8; 6-months post-partum)
  • Dyadic Adjustment Scale(Baseline; Week 8; 6-months post-partum)
  • Perceived Stress Scale(Baseline; Week 8; bimonthly until 6-months postpartum;)
  • Self-Compassion Scale(Baseline; Week 8; 6-months post-partum)
  • Prenatal Attachment Inventory(Baseline; Week 8)
  • Post-partum bonding questionnaire(6-months postpartum)
  • Interpersonal Relationships Inventory (interpersonal support subscale)(Baseline; Week 8; 6-months post-partum)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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