Antenatal Yoga Intervention for Depressed and Anxious Women

Sponsor
Hopital Montfort (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05299190
Collaborator
(none)
0
2
22

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga intervention plus TAU
  • Other: Clinical Monitoring plus TAU
N/A

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
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoringParticipants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoring
Masking:
Single (Outcomes Assessor)
Masking Description:
The MINI will be administered at 6-months post-partum by a blind assessor
Primary Purpose:
Treatment
Official Title:
Feasibility, Acceptability and Preliminary Efficacy of a Hospital-based Antenatal Yoga Program for Anxious and Depressed Women
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Aug 24, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Edinburgh Postnatal Depression Scale [Baseline; week 4; week 8; bimonthly until 6 months postpartium]

    measure of depressive symptoms

Secondary Outcome Measures

  1. Perceived Stress Scale [Baseline; Week 8; bimonthly until 6-months postpartum;]

    measure of stress

  2. Interpersonal Relationships Inventory (interpersonal support subscale) [Baseline; Week 8; 6-months post-partum]

    Measure of interpersonal support

  3. Dyadic Adjustment Scale [Baseline; Week 8; 6-months post-partum]

    Measure of marital adjustment

  4. Five Facet Mindfulness Scale [Baseline; Week 8; 6-months post-partum]

    Measure of facets of mindfulness

  5. Self-Compassion Scale [Baseline; Week 8; 6-months post-partum]

    Measure of self-compassion

  6. Prenatal Attachment Inventory [Baseline; Week 8]

    Measure of prenatal attachment

  7. Post-partum bonding questionnaire [6-months postpartum]

    Measure of post-partum bonding

Other Outcome Measures

  1. Feasibility outcomes [Week 1 to 8]

    Ease of recruitment; study compliance, program satisfaction; perception of treatment credibility

  2. Pregnancy outcomes [Baseline and week 8 and post-partum]

    Presence of gestational diabetes and hypertension; gestational age at delivery, mode of delivery, pregnancy and birth complications, infant birth weight; Apgar scores

  3. Stress hormones [Baseline and week 8 for mother and 8-weeks and 6-months for infant]

    Salivary cortisol and alpha amylase

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 45 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hopital Montfort

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hopital Montfort
ClinicalTrials.gov Identifier:
NCT05299190
Other Study ID Numbers:
  • HMontfort
First Posted:
Mar 28, 2022
Last Update Posted:
Mar 28, 2022
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2022