Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
NCT ID: NCT06881693
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-24
2026-06-30
Brief Summary
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Detailed Description
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Internet-delivered cognitive behaviour therapy (ICBT) is an effective and accessible treatment. The Online Therapy Unit (OTU) routinely delivers ICBT programs for various concerns to Saskatchewan residents. ICBT programs offered by OTU have shown great success, particularly in addressing symptoms of depression and anxiety. Furthermore, previous trials conducted by OTU - Maternal Depression Online and Wellbeing Course for New Moms - have demonstrated the effectiveness of the programs in addressing postnatal depression and anxiety among birthing parents.
Despite the effectiveness of these programs, they were limited in scope; Maternal Depression Online was primarily designed to address depression, and both programs were offered exclusively to postnatal birthing parents. Accordingly, the Wellbeing Course for New and Expecting Parents (WCNEP) has been developed as an 8-week transdiagnostic ICBT program for perinatal birthing and non-birthing parents experiencing depression and/or anxiety. To develop the WCNEP, the Wellbeing Course for New Moms was adapted for parents across the perinatal stage by revising the program content and incorporating additional patient stories of perinatal birthing and non-birthing parents.
Although recruitment and service provision will include both birthing and non-birthing perinatal parents, the Course will be evaluated in two phases. In phase 1, the investigators will evaluate the Course for perinatal birthing parents. In phase 2, the investigators will evaluate the course for non-birthing parents. Prospective clients may learn about the WCNEP from advertisements to the public, healthcare providers, and community organizations. Interested clients will be directed to the study website to complete a screening protocol. Clients will subsequently book and complete a telephone screening with an OTU therapist. Following the telephone screening, eligible clients will be enrolled in the WCNEP. Participants will have access to five lessons that they will complete in consecutive order with 1 to 2 weeks between lessons. They will be asked to complete questionnaires at various time points, and provided with homework activities to complete after each lesson. Participants will also have access to therapist support for a minimum of 8 weeks, which can be extended up to 12 weeks in the event that the birth of a child or some unexpected event occurs during the duration of the Course. After completing treatment, a subset of participants will take part in a semi-structured interview for feedback on overall course content and specific course components (i.e., patient stories).
The overall goals of the study are to evaluate the effectiveness of the intervention on various outcomes in perinatal parents over time, and the uptake of and engagement with different components (e.g., patient stories) of the treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Wellbeing Course for New and Expecting Parents
Participants in the current study will be perinatal parents experiencing symptoms of depression and/or anxiety. All participants will have access to 5 ICBT lessons released gradually over 8 weeks. The 5 ICBT lessons target challenges and symptoms of anxiety and depression in perinatal parents and focus on: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are text-based with visual images, and are presented as slideshows, stories, homework reflections, and additional resources.
Internet-delivered Cognitive Behavioural Therapy
The Wellbeing Course for New and Expecting Parents (WCNEP) is an adaptation of the Wellbeing Course (developed and evaluated at Macquaire University, Australia) and the Wellbeing Course for New Moms (a Canadian adaptation of the Wellbeing Course for new moms). The WCNEP is a transdiagnostic ICBT intervention designed for perinatal parents experiencing depression and/or anxiety, and will be offered by the Online Therapy Unit, a unit providing routine care ICBT services in Canada. The WCNEP will be evaluated in phases; phase 1 will evaluate the course for birthing parents only and phase 2 will evaluate the course for birthing and non-birthing parents. Therapist support will be offered for 8 weeks, with the possibility to extend the support to 12 weeks. Therapists will spend \~15 minutes/week communicating with each client, via secure messages. Phone calls will only be made if there is a significant clinical issue requiring attention that the therapist feel cannot be addressed in messages.
Interventions
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Internet-delivered Cognitive Behavioural Therapy
The Wellbeing Course for New and Expecting Parents (WCNEP) is an adaptation of the Wellbeing Course (developed and evaluated at Macquaire University, Australia) and the Wellbeing Course for New Moms (a Canadian adaptation of the Wellbeing Course for new moms). The WCNEP is a transdiagnostic ICBT intervention designed for perinatal parents experiencing depression and/or anxiety, and will be offered by the Online Therapy Unit, a unit providing routine care ICBT services in Canada. The WCNEP will be evaluated in phases; phase 1 will evaluate the course for birthing parents only and phase 2 will evaluate the course for birthing and non-birthing parents. Therapist support will be offered for 8 weeks, with the possibility to extend the support to 12 weeks. Therapists will spend \~15 minutes/week communicating with each client, via secure messages. Phone calls will only be made if there is a significant clinical issue requiring attention that the therapist feel cannot be addressed in messages.
Eligibility Criteria
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Inclusion Criteria
* Self-reported difficulty with depression and/or anxiety;
* Are aged 18 years or older; or 16 if participant meets criteria to be treated as a mature minor based on Saskatchewan legislation;
* Willingness to learn information and skills to self-manage mental health difficulties, consent to course and associated research.
Exclusion Criteria
* Living outside of Saskatchewan;
* Unable to read and understand English. (All content is provided in English and staff is English speaking; it is cost prohibitive at this time to provide the complete service in languages other than English).
18 Years
ALL
No
Sponsors
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Government of Saskatchewan, Ministry of Health
UNKNOWN
Macquarie University, Australia
OTHER
University of Regina
OTHER
Responsible Party
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Principal Investigators
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Heather Hadjistavropoulos, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Regina
Locations
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Online Therapy Unit
Regina, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Link to the primary unit running the study
Other Identifiers
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985
Identifier Type: -
Identifier Source: org_study_id
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