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MindfulnessNCT03026959

Mindfulness and Maternal Mental Health

A study testing Mindfulness in people with Mindfulness, run by Lakehead University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is preliminary empirical support for the use of mindfulness interventions during the perinatal period; suggesting that mindfulness training may be an effective treatment approach for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress, and psychological distress during the… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Mindfulness
What is being tested?
Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteCanada
Study dates
Nov 2016to May 2019
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • pregnant, age 18 years and older, able and willing to attend the study site for the four group sessions.

Who cannot join

  • presence of a current severe mental health condition or mental heath difficulties that would be better addressed through another form of therapy, active major medical illness including significant obstetric complications, inability to give informed consent, inability to speak or understand English, at high risk for delivery before reaching full term (38 weeks gestation), or previous completion of a structured mindfulness-based program.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Lakehead University

    Thunder Bay, Ontario, P7B 5E1

Other trials in Canada

About this study

Official title: The Role of Mindfulness Skills Training in Maternal Mental Health: A Randomized Controlled Trial

There is preliminary empirical support for the use of mindfulness interventions during the perinatal period; suggesting that mindfulness training may be an effective treatment approach for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress, and psychological distress during the postpartum period. To extend on these findings, the purpose of this research is to evaluate the effectiveness of a brief mindfulness-based program in protecting maternal mental health and well-being using a randomized controlled trial.

Read the detailed description

Based on the results reported in the existing literature that show that formal mindfulness-based practice is effective for improving mental health status and preventing depressive symptom relapse, this research aims to evaluate the effectiveness of a brief mindfulness-based program, offered during pregnancy, in reducing mothers' psychological symptoms during pregnancy and the postpartum period. A brief program has the advantage being more economical to facilitate compared to full-length programs and also requires a shorter commitment from pregnant women, who are also attempting to manage multiple other new and existing demands (e.g., obstetrics appointments, work).

As emerging research suggests that women are particularly vulnerable to increased depressive, anxious, obsessive, compulsive, and hypomanic symptoms during the perinatal period these are the main psychological symptoms that will be assessed. As well, perceived stress and psychological resiliency will also be assessed for in order to examine changes in these domains in relation to mindfulness engagement. Furthermore, as a reduction in maternal psychological symptoms has been reported to have implications for mother-infant bond, the mother's interpersonal functioning, and maternal quality of life, the investigators will also assess to see if there are corresponding changes in these domains related to mindfulness engagement.

Conditions
Mindfulness
Being tested
Mindfulness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindfulnessBehavioural

    The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, \& Bédard, (2015).

Study groups in NCT03026959
Study groupRoleWhat they receive
Mindfulness GroupExperimentalParticipants assigned to the mindfulness group will attend four weekly sessions that are each 1.5 hours in length. The sessions will follow the structure described by Short, Mazmanian, Ozen, \& Bédard (2015). The structure is designed to first enhance learners' foundation skills in mindfulness and progresses into teaching learners more advanced mindfulness skills.
Receives: Behavioral: Mindfulness
Social (control) GroupNo interventionParticipants assigned to the social group will also attend four weekly sessions that are each 1.5 hours in length. Each session will have participants focus on a creative tasks while permitting task related discussion. In this way the format is designed to parallel the mindfulness group, where participants engage in a new activity each week and have an opportunity to discuss the activities with the group without engaging in any formal intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Edinburgh Postnatal Depression Scale

    Measured: 12 weeks postpartum

  2. Hospital Anxiety and Depression Scale - Anxiety Subscale

    Measured: 12 weeks postpartum

  3. Obsessive-Compulsive Inventory-Revised

    Measured: 12 weeks postpartum

  4. Altman Self-Rating Mania Scale

    Measured: 12 weeks postpartum

  5. Five Facet Mindfulness Questionnaire

    Measured: 12 weeks postpartum

Secondary outcomes (5)

  1. Perceived Stress Scale

    Measured: 12 weeks postpartum

  2. Brief Resilience Scale

    Measured: 12 weeks postpartum

  3. Postpartum Bonding Questionnaire

    Measured: 12 weeks postpartum

  4. World Health Organization Quality of Life Scale

    Measured: 12 weeks postpartum

  5. Multidimensional Scale of Perceived Social Support

    Measured: 12 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study startNov 2016
  3. Primary completionMay 2019
  4. Study completionMay 2019

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026959
Sponsor's protocol ID
083 16-17
Status last verified
Aug 2019
First submitted
1 Dec 2016
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bedard M, Felteau M, Marshall S, Cullen N, Gibbons C, Dubois S, Maxwell H, Mazmanian D, Weaver B, Rees L, Gainer R, Klein R, Moustgaard A. Mindfulness-based cognitive therapy reduces symptoms of depression in people with a traumatic brain injury: results from a randomized controlled trial. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):E13-22. doi: 10.1097/HTR.0b013e3182a615a0.

    PubMed 24052092

  • Davey HL, Tough SC, Adair CE, Benzies KM. Risk factors for sub-clinical and major postpartum depression among a community cohort of Canadian women. Matern Child Health J. 2011 Oct;15(7):866-75. doi: 10.1007/s10995-008-0314-8. Epub 2008 Feb 7.

    PubMed 18256913

  • Helmes E, Ward BG. Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care. Aging Ment Health. 2017 Mar;21(3):272-278. doi: 10.1080/13607863.2015.1111862. Epub 2015 Nov 13.

    PubMed 26565928

  • O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.

    PubMed 24140480

  • Pope CJ, Sharma V, Mazmanian D. Recognition, diagnosis and treatment of postpartum bipolar depression. Expert Rev Neurother. 2014 Jan;14(1):19-28. doi: 10.1586/14737175.2014.846219. Epub 2013 Nov 26.

    PubMed 24308278

  • Russell EJ, Fawcett JM, Mazmanian D. Risk of obsessive-compulsive disorder in pregnant and postpartum women: a meta-analysis. J Clin Psychiatry. 2013 Apr;74(4):377-85. doi: 10.4088/JCP.12r07917.

    PubMed 23656845

  • Short MM, Mazmanian D, Ozen LJ, Bédard M. Four days of mindfulness meditation training for graduate students: A pilot study examining effects on mindfulness, self-regulation, and executive function. J Contemplative Inq. 2015; 2(1). http://journal.contemplativeinquiry.org/index.php/joci/article/view/13

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness in people with Mindfulness, run by Lakehead University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 12 weeks postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026959, which also lists 7 linked publications.

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 13 Aug 2019.

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