Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
NCT ID: NCT06778096
Last Updated: 2025-05-13
Study Results
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Basic Information
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RECRUITING
NA
226 participants
INTERVENTIONAL
2025-05-31
2026-07-31
Brief Summary
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\[1\] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in community-based care for women with anxiety and depressive symptoms, is the iCBT+TAU condition more effective to reduce symptoms than TAU alone?
Participants will:
postnatal iCBT group -\> Answer questionnaires before, after (week 6) and 4 weeks after the intervention (week 10); do the 6-week non-guided iCBT program for anxiety and depressive symptoms during the postnatal period.
Waitlist, TAU group -\> Answer questionnaires at enrolment, at week 6 and week 10. Participants will have access to the intervention after they complete their last questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The postnatal anxiety and depression iCBTprogram + TAU
Women will have access to the postnatal iCBT program (self-directed) and will have to complete the program over six weeks. They still can have contacts with the healthcare system.
Postnatal anxiety and depression iCBTprogram
The overarching goal of this stand-alone program is to introduce women to CBT skills to help manage symptoms of anxiety and depression, such as psychoeducation, cognitive restructuring and problem solving, behavioural activation, graded exposure and relapse prevention. Each lesson is accompanied by practical homework and resources (e.g., medication during breastfeeding, attachment and bonding, information for entourage, sleep, self-care, intrusive thought, problem solving), and is built to be easily generalizable to a broad range of women. The three lessons must be completed within a 6-week period, with up to two weeks to complete each lesson. Participants will be notified of new lessons available via email and text message reminders. There is a 5-day lockout between lessons stopping the participants to complete the next session once a session is completed to ensure that the sessions are completed over multiple weeks to allow for revision and practice.
Treatment-as-usual
No restrictions will be imposed regarding usual care. To reflect heterogeneity of health seeking behaviour and mental health practices for anxiety and depressive symptoms in the community during the postpartum period, participants will not be constrained to a prespecified usual care treatment for external validity or have contacts with the healthcare system. Data will be collected on throughout the trial. This group will have a delayed access to the program after they complete their four-week follow-up questionnaire.
No interventions assigned to this group
Interventions
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Postnatal anxiety and depression iCBTprogram
The overarching goal of this stand-alone program is to introduce women to CBT skills to help manage symptoms of anxiety and depression, such as psychoeducation, cognitive restructuring and problem solving, behavioural activation, graded exposure and relapse prevention. Each lesson is accompanied by practical homework and resources (e.g., medication during breastfeeding, attachment and bonding, information for entourage, sleep, self-care, intrusive thought, problem solving), and is built to be easily generalizable to a broad range of women. The three lessons must be completed within a 6-week period, with up to two weeks to complete each lesson. Participants will be notified of new lessons available via email and text message reminders. There is a 5-day lockout between lessons stopping the participants to complete the next session once a session is completed to ensure that the sessions are completed over multiple weeks to allow for revision and practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Being within 12 months postpartum
* Fluent in spoken and written French
* Self-reported clinical score ≥10 for anxiety and/or depressive symptoms based on the Generalised Anxiety Disorder-7 (GAD-7) and the Edinburgh Postnatal Depression Scale 10-item scale (EPDS)
* Access to a computer/tablet and internet connection
* Agreement to share primary provider contact information
Exclusion Criteria
* Current substance abuse or dependence
* Current use of benzodiazepines
* Beginning psychological therapy (\< 4 weeks ago) or medication (\< 8 weeks ago) for depression/anxiety
* Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)
18 Years
FEMALE
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
UNKNOWN
Centre intégré de santé et services sociaux de la Montérégie-Centre
UNKNOWN
Centre intégré de santé et services sociaux de la Montérégie-Ouest
UNKNOWN
Centre intégré de santé et services sociaux de la Montérégie-Est
UNKNOWN
Champlain Local Health Integration Network
UNKNOWN
Université de Sherbrooke
OTHER
Responsible Party
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Principal Investigators
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Pasquale Roberge, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Helen-Maria Vasiliadis, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Centre intégré de santé et services sociaux de la Montérégie-Ouest
Châteauguay, Quebec, Canada
Centre intégré de santé et services sociaux de la Montérégie-Est
Greenfield Park, Quebec, Canada
Centre intégré de santé et services sociaux de la Montérégie-Centre
Longueuil, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Loughnan SA, Butler C, Sie AA, Grierson AB, Chen AZ, Hobbs MJ, Joubert AE, Haskelberg H, Mahoney A, Holt C, Gemmill AW, Milgrom J, Austin MP, Andrews G, Newby JM. A randomised controlled trial of 'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women. Behav Res Ther. 2019 May;116:94-103. doi: 10.1016/j.brat.2019.03.001. Epub 2019 Mar 8. No abstract available.
Roberge P, Vasiliadis HM, Chapdelaine A, Battista MC, Beaulieu MC, Chomienne MH, Cumyn A, Drapeau M, Durand C, Girard A, Gosselin D, Grenier J, Hardy I, Hudon C, Koszycki D, Labelle R, Lesage A, Lussier MT, Mahoney A, Provencher MD, Shiner CT. Transdiagnostic internet cognitive behavioural therapy for anxiety and depressive symptoms in postnatal women: protocol of a randomized controlled trial. BMC Psychiatry. 2025 Mar 13;25(1):237. doi: 10.1186/s12888-025-06636-3.
Other Identifiers
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MP-31-2024-5238
Identifier Type: -
Identifier Source: org_study_id
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