NCT02953626

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

June 13, 2016

Last Update Submit

May 11, 2017

Conditions

Keywords

pilot RCTwaitlist-controlled RCTpostpartum depression

Outcome Measures

Primary Outcomes (1)

  • Recruitment Feasibility (Eligibility)

    The proportion of participants eligible to participate in Mother Matters

    One year from when the study starts enrolling participants

Secondary Outcomes (10)

  • Edinburgh Postnatal Depressive Scale (EPDS)

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

  • State-Trait Anxiety Inventory (STAI)

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

  • The Change in Eating Disorder Symptoms Scale (CHEDS)

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

  • Parenting Stress Index, Short Form (PSI)

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

  • Intervention Acceptability (Qualitative)

    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)

  • +5 more secondary outcomes

Study Arms (2)

Immediate Treatment Condition (ITC)

EXPERIMENTAL

Mother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization.

Behavioral: Mother Matters Online Postpartum Support Group

Waitlist Control Condition (WLC)

NO INTERVENTION

Mother 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.

Interventions

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.

Immediate Treatment Condition (ITC)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Research Institute

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (20)

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

    PMID: 19680490BACKGROUND
  • 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.

    PMID: 19164843BACKGROUND
  • 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.

    PMID: 26246794BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26125602BACKGROUND
  • 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.

    PMID: 24160774BACKGROUND
  • 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.

    PMID: 25345371BACKGROUND
  • 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.

    PMID: 21146231BACKGROUND
  • 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.

    PMID: 17150072BACKGROUND
  • 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.

    PMID: 23460682BACKGROUND
  • 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.

    PMID: 21167078BACKGROUND
  • 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/

    PMID: 26180865BACKGROUND
  • 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.

    PMID: 22019021BACKGROUND
  • 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.

    PMID: 20434058BACKGROUND
  • 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.

    PMID: 16597226BACKGROUND
  • Harris AA. Practical advice for caring for women with eating disorders during the perinatal period. J Midwifery Womens Health. 2010 Nov-Dec;55(6):579-86. doi: 10.1016/j.jmwh.2010.07.008.

    PMID: 20974420BACKGROUND
  • Micali N, Simonoff E, Stahl D, Treasure J. Maternal eating disorders and infant feeding difficulties: maternal and child mediators in a longitudinal general population study. J Child Psychol Psychiatry. 2011 Jul;52(7):800-7. doi: 10.1111/j.1469-7610.2010.02341.x. Epub 2010 Nov 12.

    PMID: 21073463BACKGROUND
  • Coker E, Abraham S. Body weight dissatisfaction before, during and after pregnancy: a comparison of women with and without eating disorders. Eat Weight Disord. 2015 Mar;20(1):71-9. doi: 10.1007/s40519-014-0133-4. Epub 2014 Jun 7.

    PMID: 24906550BACKGROUND
  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PMID: 18183564BACKGROUND
  • Meltzer-Brody S, Zerwas S, Leserman J, Holle AV, Regis T, Bulik C. Eating disorders and trauma history in women with perinatal depression. J Womens Health (Larchmt). 2011 Jun;20(6):863-70. doi: 10.1089/jwh.2010.2360.

    PMID: 21671774BACKGROUND

MeSH Terms

Conditions

DepressionDepression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Simone Vigod, MD,MSc,FRCPC

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

November 3, 2016

Study Start

May 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations