Anxiety DepressionNCT05299190
Antenatal Yoga Intervention for Depressed and Anxious Women
A study testing Yoga intervention plus TAU and Clinical Monitoring plus TAU in people with Anxiety Depression, run by Hopital Montfort.
Trial 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? Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Yoga intervention plus TAU and Clinical Monitoring plus TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
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.
About this study
Official title: Feasibility, Acceptability and Preliminary Efficacy of a Hospital-based Antenatal Yoga Program for Anxious and Depressed Women
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?
Read the 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
- Being tested
- Yoga intervention plus TAU, Clinical Monitoring plus TAU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga intervention plus TAUOther
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 TAUOther
clinical monitoring includes bi-weekly 15-20 minute telephone contact with participants. TAU is usual care participants receive from their health care provider.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Clinical Monitoring plus TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
measure of depressive symptoms
Measured: Baseline; week 4; week 8; bimonthly until 6 months postpartium
Secondary outcomes (7)
Perceived Stress Scale
measure of stress
Measured: Baseline; Week 8; bimonthly until 6-months postpartum;
Interpersonal Relationships Inventory (interpersonal support subscale)
Measure of interpersonal support
Measured: Baseline; Week 8; 6-months post-partum
Dyadic Adjustment Scale
Measure of marital adjustment
Measured: Baseline; Week 8; 6-months post-partum
Five Facet Mindfulness Scale
Measure of facets of mindfulness
Measured: Baseline; Week 8; 6-months post-partum
Self-Compassion Scale
Measure of self-compassion
Measured: Baseline; Week 8; 6-months post-partum
Prenatal Attachment Inventory
Measure of prenatal attachment
Measured: Baseline; Week 8
Post-partum bonding questionnaire
Measure of post-partum bonding
Measured: 6-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Mar 2020 (estimated)
- Primary completion24 Aug 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: Recruitment challenges due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoring
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Montfort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Koszycki, PhD, Principal investigator, Institut du Savoir Montfort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299190
- Sponsor's protocol ID
- HMontfort
- Status last verified
- Aug 2019
- First submitted
- 26 Feb 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Preliminary Efficacy of a Hospital-based Antenatal Yoga Program for Anxious and Depressed Women
- ClinicalTrials.gov ID
- NCT05299190
- Acronym / sponsor ID
- HMontfort
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment challenges due to COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hopital MontfortUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 24 Aug 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the yoga intervention plus treatment as usual (TAU) or TAU plus biweekly clinical monitoring
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention plus TAU | Experimental | Other: Yoga intervention plus TAUParticipants 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. |
| Clinical Monitoring plus TAU | Other | Other: Clinical Monitoring plus TAUClinical 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga intervention plus TAUThe 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 | Yoga intervention plus TAU |
| Clinical Monitoring plus TAUclinical monitoring includes bi-weekly 15-20 minute telephone contact with participants. TAU is usual care participants receive from their health care provider. | Other | Clinical Monitoring plus TAU |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: Baseline; week 4; week 8; bimonthly until 6 months postpartium
measure of depressive symptoms
7 secondary outcomes
Perceived Stress Scale
Time frame: Baseline; Week 8; bimonthly until 6-months postpartum;
Interpersonal Relationships Inventory (interpersonal support subscale)
Time frame: Baseline; Week 8; 6-months post-partum
Dyadic Adjustment Scale
Time frame: Baseline; Week 8; 6-months post-partum
Five Facet Mindfulness Scale
Time frame: Baseline; Week 8; 6-months post-partum
Self-Compassion Scale
Time frame: Baseline; Week 8; 6-months post-partum
Prenatal Attachment Inventory
Time frame: Baseline; Week 8
Post-partum bonding questionnaire
Time frame: 6-months postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Koszycki, PhD principal investigator
Institut du Savoir Montfort
Questions about this trial
What is this clinical trial studying?
A study testing Yoga intervention plus TAU and Clinical Monitoring plus TAU in people with Anxiety Depression, run by Hopital Montfort.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: Baseline; week 4; week 8; bimonthly until 6 months postpartium). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.