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DepressionNCT02953626

Mother Matters Online Postpartum Support

A study testing Mother Matters Online Postpartum Support Group in people with Depression, run by Women's College Hospital 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

Postpartum depression is common, yet only 20% of women seek treatment. Online support groups are a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online psychotherapy group for women with postpartum depression \& anxiety. 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
Depression
What is being tested?
Mother Matters Online Postpartum Support Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteCanada
Study dates
May 2016to May 2017
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

  • The specific inclusion criteria for this group are women who are:
  • Mothers of a baby/babies between 0 and 12 months old at enrollment, and
  • Over 18 years old, and
  • Have an Edinburgh Postnatal Depression Scale (EPDS) score of >9, and
  • Reside in Ontario.

Who cannot join

  • Women will not be eligible to participate in the study if they are:
  • Experiencing active suicidal ideation, or
  • Have active substance use, mania or psychosis, or
  • Unable to access the internet, or
  • Unable to participate in English.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Women's College Research Institute

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

Official title: Mother Matters: Pilot Randomized Waitlist Controlled Trial of an Online Postpartum Mental Health Support Group

Postpartum depression is common, yet only 20% of women seek treatment. Online support groups are a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online psychotherapy group for women with postpartum depression \& anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of proceeding to a large-scale RCT evaluation of the Mother Matters intervention.

Read the detailed description

The postpartum period is a particularly vulnerable time for the development of mental health concerns; postpartum depression (i.e. depression with onset between 0-12 months postpartum) affects approximately 13% of mothers in Canada. There are serious negative consequences to both mother and child during this period, yet only 20% of women seek treatment, citing significant systematic and personal barriers. Online support groups have been identified as a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online support group for women with postpartum depression and anxiety, run trained psychotherapists in the Reproductive Life Stages (RLS) program at Women's College Hospital in Toronto, Ontario. Mother Matters was designed to address barriers related to accessing postpartum mental health services: it can be accessed anywhere (online group), at any time (available 24/7), and with anonymity (to address the barrier of shame/stigma). The overall objective of the current pilot RCT is to determine the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the group, comparing outcomes among those with and without access to the program.

Conditions
Depression
Being tested
Mother Matters Online Postpartum Support Group
Keywords
pilot RCT, waitlist-controlled RCT, postpartum depression
Medical subject headings
Depression, Depression, Postpartum

What participants receive

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

  • Mother Matters Online Postpartum Support GroupBehavioural

    Mother Matters is a 10-week online support group for women with postpartum depression. It involves: 1) A private, online forum that can be accessed by participants 24-hours per day. During regular business hours (9:00 am to 5:00 pm on weekdays) it is moderated by a psychotherapist, and there is a weekly moderated "live" chat hour; 2) Weekly topics with readings are provided with questions to prompt discussion on the online forum. Topics incorporate symptom management (i.e. Interpersonal Therapy, Cognitive Behavioural Therapy) and affect regulation strategies (i.e. Mindfulness, DBT) with a supportive counselling approach. External resources related to each week's topic, are also shared.

Study groups in NCT02953626
Study groupRoleWhat they receive
Immediate Treatment Condition (ITC)ExperimentalMother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization.
Receives: Behavioral: Mother Matters Online Postpartum Support Group
Waitlist Control Condition (WLC)No interventionMother Matters Online Postpartum Support Group. Participants will receive the intervention after the Immediate Treatment Condition group completes the intervention, and after follow-up data are collected from both groups.

What is being measured

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

  1. Recruitment Feasibility (Eligibility)

    The proportion of participants eligible to participate in Mother Matters

    Measured: One year from when the study starts enrolling participants

Secondary outcomes (10)

  1. Edinburgh Postnatal Depressive Scale (EPDS)

    The investigators will measure depressive symptoms using the EPDS, a self-report depression screening measure that has been validated for use in pregnancy. EPDS scores >12 are predictive of a diagnosis of major depressive disorder.

    Measured: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)

  2. State-Trait Anxiety Inventory (STAI)

    The investigators will measure anxious symptoms using the STAI, a self-report anxiety screening measure that has shown good discriminate validity in perinatal populations. STAI scores >48 are predictive of having an anxiety disorder diagnosis.

    Measured: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)

  3. The Change in Eating Disorder Symptoms Scale (CHEDS)

    The investigators will measure eating disorder symptoms use the CHEDS, which is designed to assess change in eating disorder symptoms and their severity.

    Measured: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)

  4. Parenting Stress Index, Short Form (PSI)

    The investigators will measure stress in the parent-child relationship using the PSI short form, a 36-item measure which consists of three sub-scales.

    Measured: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)

  5. Intervention Acceptability (Qualitative)

    Mother Matters Program Evaluation Questionnaire. This is comprised of open- and closed-ended questions to elicit feedback on a) content, clarity and helpfulness of the group, b) acceptability of the group format, c) satisfaction with the group, including reasons for discontinuation, d) the facilitators availability and helpfulness, and e) whether or not participants would recommend it to other women experiencing depressive symptoms in the first postpartum year.

    Measured: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)

  6. Intervention Acceptability (Website Usage)

    Proportion of intervention weeks that participant logs in to the forum

    Measured: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)

  7. Trial Protocol Adherence (Study Measure Completion)

    Proportion of participants who complete follow-up measures

    Measured: Follow-up (about 10 weeks post-randomization)

  8. Recruitment Feasibility (Recruitment)

    The number of women recruited to the study

    Measured: One year from when the study starts enrolling participants

  9. Trial Protocol Adherence (Weekly Posting)

    The number of participants who post in the forum at least on a weekly basis

    Measured: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)

  10. Trial Protocol Adherence (Posting Drop-Off)

    The drop-off rate for postings (i.e. the number of participants who post in the initial weeks but not in the latter half of the group)

    Measured: Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts)

Timeline

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

  1. First posted3 Nov 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMar 2017
  4. Study completionMay 2017

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953626
Sponsor's protocol ID
2016-0032-B
Status last verified
May 2017
First submitted
13 Jun 2016
Last updated
12 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Maternal depression and child development. Paediatr Child Health. 2004 Oct;9(8):575-598. doi: 10.1093/pch/9.8.575. No abstract available.

    PubMed 19680490

  • Marcus SM. Depression during pregnancy: rates, risks and consequences--Motherisk Update 2008. Can J Clin Pharmacol. 2009 Winter;16(1):e15-22. Epub 2009 Jan 22.

    PubMed 19164843

  • Meltzer-Brody S, Jones I. Optimizing the treatment of mood disorders in the perinatal period. Dialogues Clin Neurosci. 2015 Jun;17(2):207-18. doi: 10.31887/DCNS.2015.17.2/smeltzerbrody.

    PubMed 26246794

  • Roberta Anniverno, A.B., Claudio Mencacci and Federico Durbano, Anxiety Disorders in Pregnancy and the Postpartum Period, in New Insights into Anxiety Disorders, D.F. Durbano, Editor. 2013.

  • Misri S, Abizadeh J, Sanders S, Swift E. Perinatal Generalized Anxiety Disorder: Assessment and Treatment. J Womens Health (Larchmt). 2015 Sep;24(9):762-70. doi: 10.1089/jwh.2014.5150. Epub 2015 Jun 30.

    PubMed 26125602

  • Farr SL, Dietz PM, O'Hara MW, Burley K, Ko JY. Postpartum anxiety and comorbid depression in a population-based sample of women. J Womens Health (Larchmt). 2014 Feb;23(2):120-8. doi: 10.1089/jwh.2013.4438. Epub 2013 Oct 26.

    PubMed 24160774

  • Easter A, Solmi F, Bye A, Taborelli E, Corfield F, Schmidt U, Treasure J, Micali N. Antenatal and postnatal psychopathology among women with current and past eating disorders: longitudinal patterns. Eur Eat Disord Rev. 2015 Jan;23(1):19-27. doi: 10.1002/erv.2328. Epub 2014 Oct 26.

    PubMed 25345371

  • Micali N, Simonoff E, Treasure J. Pregnancy and post-partum depression and anxiety in a longitudinal general population cohort: the effect of eating disorders and past depression. J Affect Disord. 2011 Jun;131(1-3):150-7. doi: 10.1016/j.jad.2010.09.034. Epub 2010 Dec 10.

    PubMed 21146231

  • Dennis CL, Chung-Lee L. Postpartum depression help-seeking barriers and maternal treatment preferences: a qualitative systematic review. Birth. 2006 Dec;33(4):323-31. doi: 10.1111/j.1523-536X.2006.00130.x.

    PubMed 17150072

  • Paul IM, Downs DS, Schaefer EW, Beiler JS, Weisman CS. Postpartum anxiety and maternal-infant health outcomes. Pediatrics. 2013 Apr;131(4):e1218-24. doi: 10.1542/peds.2012-2147. Epub 2013 Mar 4.

    PubMed 23460682

  • Yelland J, Sutherland G, Brown SJ. Postpartum anxiety, depression and social health: findings from a population-based survey of Australian women. BMC Public Health. 2010 Dec 20;10:771. doi: 10.1186/1471-2458-10-771.

    PubMed 21167078

  • National Collaborating Centre for Mental Health (UK). Antenatal and Postnatal Mental Health: Clinical Management and Service Guidance: Updated edition. Leicester (UK): British Psychological Society; 2014 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK305023/

    PubMed 26180865

  • Evans M, Donelle L, Hume-Loveland L. Social support and online postpartum depression discussion groups: a content analysis. Patient Educ Couns. 2012 Jun;87(3):405-10. doi: 10.1016/j.pec.2011.09.011. Epub 2011 Oct 20.

    PubMed 22019021

  • Spangler DL. The Change in Eating Disorder Symptoms scale: scale development and psychometric properties. Eat Behav. 2010 Aug;11(3):131-7. doi: 10.1016/j.eatbeh.2009.12.003. Epub 2009 Dec 11.

    PubMed 20434058

  • Haskett ME, Ahern LS, Ward CS, Allaire JC. Factor structure and validity of the parenting stress index-short form. J Clin Child Adolesc Psychol. 2006 Jun;35(2):302-12. doi: 10.1207/s15374424jccp3502_14.

    PubMed 16597226

Questions about this trial

What is this clinical trial studying?

A study testing Mother Matters Online Postpartum Support Group in people with Depression, run by Women's College Hospital 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 5 inclusion and 5 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 12 May 2017. 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?

Recruitment Feasibility (Eligibility) (time frame: One year from when the study starts enrolling participants). 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 NCT02953626, which also lists 20 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 12 May 2017.

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Mother Matters Online Postpartum Support (NCT02953626) | AzTrials