Clinical trial NCT02953626: Mother Matters Online Postpartum Support
Official title: Mother Matters: Pilot Randomized Waitlist Controlled Trial of an Online Postpartum Mental Health Support Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: pilot RCT
waitlist-controlled RCT
postpartum depression
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: Sunnybrook Health Sciences Centre
name: University of Toronto
First posted: 2016-11-03
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria

The specific inclusion criteria for this group are women who are:

1. Mothers of a baby/babies between 0 and 12 months old at enrollment, and
2. Over 18 years old, and
3. Have an Edinburgh Postnatal Depression Scale (EPDS) score of \>9, and
4. Reside in Ontario.

Exclusion Criteria

Women will not be eligible to participate in the study if they are:

1. Experiencing active suicidal ideation, or
2. Have active substance use, mania or psychosis, or
3. Unable to access the internet, or
4. Unable to participate in English.

Primary outcomes:
measure: Recruitment Feasibility (Eligibility)
timeFrame: One year from when the study starts enrolling participants
Secondary outcomes:
measure: Edinburgh Postnatal Depressive Scale (EPDS)
timeFrame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
measure: The Change in Eating Disorder Symptoms Scale (CHEDS)
timeFrame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
measure: Parenting Stress Index, Short Form (PSI)
timeFrame: Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
measure: Intervention Acceptability (Qualitative)
timeFrame: 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)
measure: Intervention Acceptability (Website Usage)
timeFrame: 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)
measure: Trial Protocol Adherence (Study Measure Completion)
timeFrame: Follow-up (about 10 weeks post-randomization)
measure: Recruitment Feasibility (Recruitment)
timeFrame: One year from when the study starts enrolling participants
measure: Trial Protocol Adherence (Weekly Posting)
timeFrame: 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)
measure: Trial Protocol Adherence (Posting Drop-Off)
timeFrame: 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)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Research Institute
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Simone Vigod, MD,MSc,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maternal depression and child development. Paediatr Child Health. 2004 Oct;9(8):575-598. doi: 10.1093/pch/9.8.575. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
citation: 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.