Anxiety Depression
Conditions
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.
Interventions
OTHERYoga 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
OTHERClinical 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.
Sponsors
Hopital Montfort
Study design
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
Intervention model description
Participants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoring
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale | Baseline; week 4; week 8; bimonthly until 6 months postpartium | measure of depressive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyadic Adjustment Scale | Baseline; Week 8; 6-months post-partum | Measure of marital adjustment |
| Self-Compassion Scale | Baseline; Week 8; 6-months post-partum | Measure of self-compassion |
| Prenatal Attachment Inventory | Baseline; Week 8 | Measure of prenatal attachment |
| Post-partum bonding questionnaire | 6-months postpartum | Measure of post-partum bonding |
| Perceived Stress Scale | Baseline; Week 8; bimonthly until 6-months postpartum; | measure of stress |
| Interpersonal Relationships Inventory (interpersonal support subscale) | Baseline; Week 8; 6-months post-partum | Measure of interpersonal support |
| Five Facet Mindfulness Scale | Baseline; Week 8; 6-months post-partum | Measure of facets of mindfulness |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stress hormones | Baseline and week 8 for mother and 8-weeks and 6-months for infant | Salivary cortisol and alpha amylase |
| Feasibility outcomes | Week 1 to 8 | Ease of recruitment; study compliance, program satisfaction; perception of treatment credibility |
| 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 |
Outcome results
None listed