Mother Matters Online Postpartum Support

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953626
• Other study ID #: 2016-0032-B
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: May 11, 2017
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Mother Matters Online Postpartum Support Group
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.

Locations

Country	Name	City	State
Canada	Women's College Research Institute	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Women's College Hospital	Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Maternal depression and child development. Paediatr Child Health. 2004 Oct;9(8):575-598. English, French, English. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility (Eligibility)	The proportion of participants eligible to participate in Mother Matters	One year from when the study starts enrolling participants
Secondary	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.	Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Secondary	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.	Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Secondary	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.	Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Secondary	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.	Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm)
Secondary	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.	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)
Secondary	Intervention Acceptability (Website Usage)	Proportion of intervention weeks that participant logs in to the forum	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)
Secondary	Trial Protocol Adherence (Study Measure Completion)	Proportion of participants who complete follow-up measures	Follow-up (about 10 weeks post-randomization)
Secondary	Recruitment Feasibility (Recruitment)	The number of women recruited to the study	One year from when the study starts enrolling participants
Secondary	Trial Protocol Adherence (Weekly Posting)	The number of participants who post in the forum at least on a weekly basis	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)
Secondary	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)	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)