A randomised controlled trial of 'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women.
Siobhan A Loughnan, Christine Butler, Amanda A Sie...
https://pubmed.ncbi.nlm.nih.gov/30877878Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06778096
Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
Led by Université de Sherbrooke · Updated on 2025-05-13
226
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Université de Sherbrooke
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research project focuses on women experiencing anxiety and depression symptoms during the postnatal period. It aims to evaluate the acceptability and effectiveness of a French-Canadian version of an internet-delivered cognitive behavioral therapy (iCBT) program. The study compares adding this iCBT program to usual community care versus usual care alone to see if it better reduces anxiety and depression symptoms. The trial is a randomized clinical study with a hybrid design to explore both clinical effects and implementation factors. Participants are assigned to one of two groups: the experimental group uses a self-directed, adapted postnatal iCBT program consisting of three lessons completed over six weeks, combined with treatment-as-usual (TAU). The control group receives TAU alone and gains access to the iCBT program after completing follow-up questionnaires. The iCBT program includes lessons on CBT skills such as psychoeducation, cognitive restructuring, problem solving, behavioral activation, graded exposure, and relapse prevention, supported by homework and resource materials. Participants receive email and text reminders with a schedule to ensure lessons are spaced over weeks. During the study, participants complete questionnaires at baseline, week 6, and week 10 to assess anxiety and depression symptoms using the Generalized Anxiety Disorder-7 and Edinburgh Postnatal Depression Scale. Additional assessments include psychological distress, quality of life, and mother-child attachment. The study collects data on healthcare use and treatment satisfaction. The total participation spans about 10 weeks, involving online program activities and questionnaire completion, with no restrictions on usual care. Safety is monitored by excluding individuals with severe depression or active suicidal intent.
CONDITIONS
Brief Title
Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 18 years and older
- Within 12 months postpartum
- Fluent in spoken and written French
- Self-reported anxiety and/or depressive symptoms with scores 60 on GAD-7 and/or EPDS
- Access to a computer or tablet with internet connection
- Agree to share primary healthcare provider contact information
You will not qualify if you...
- Self-reported diagnosis of schizophrenia or bipolar disorder
- Current substance abuse or dependence
- Current use of benzodiazepines
- Started psychological therapy less than 4 weeks ago or medication less than 8 weeks ago for depression/anxiety
- Severe depression (EPDS score 63) or active suicidal intentions (EPDS question 10 = 3, yes quite often)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 6 weeks
Participants complete a self-directed internet cognitive-behavioral therapy (iCBT) program for postnatal anxiety and depression, which includes three lessons designed to be completed over six weeks, with practical homework and resources to help manage symptoms.
1 baseline visit and 2 assessment visits during treatment
Follow-up
Duration - 4 weeks
Participants are followed for additional assessment of symptoms and quality of life after completion of the iCBT program or treatment-as-usual period.
1 follow-up visit
Trial Site Locations
Total: 4 locations
1
Centre intégré de santé et services sociaux de la Montérégie-Ouest
Châteauguay, Quebec, Canada
Actively Recruiting
2
Centre intégré de santé et services sociaux de la Montérégie-Est
Greenfield Park, Quebec, Canada
Actively Recruiting
3
Centre intégré de santé et services sociaux de la Montérégie-Centre
Longueuil, Quebec, Canada, J4V 2H2
Actively Recruiting
4
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5H3
Actively Recruiting
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Research Team
P
Pasquale Roberge, PhD
A
Alexandra Chapdelaine, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Transdiagnostic internet cognitive behavioural therapy for anxiety and depressive symptoms in postnatal women: protocol of a randomized controlled trial.
Pasquale Roberge, Helen-Maria Vasiliadis, Alexandra Chapdelaine...
https://pubmed.ncbi.nlm.nih.gov/40075340