Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents

NCT06881693 | Recruiting

• 1 other identifier: 985
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), an internet-delivered cognitive behavioral therapy (ICBT) intervention, in reducing symptoms of anxiety and depression in perinatal parents, within a routine care online therapy clinic (the Online Therapy Unit). The study aims to assess treatment uptake, perceptions, feasibility, and effectiveness of the WCNEP in routine care among birthing and non-birthing parents. Over the duration of 8 weeks, participants will review course materials online and respond to questionnaires aimed at assessing changes in various outcomes over time.

Conditions

Anxiety; Depression

Keywords

Anxiety; Depression; Internet-delivered cognitive behaviour therapy; Patient stories; Perinatal mental health

Outcome Measures

Primary Outcomes (2)

• Edinburgh Postnatal Depression Scale (EPDS)

  Tracking the change in depression symptoms. 10 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 30. Higher scores are associated with higher depression severity.

  Baseline (Screening), weeks 1-8, and 20 weeks from enrollment

• Generalized Anxiety Disorder 7-item (GAD-7)

  Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

  Baseline (Screening), weeks 1-8, and 20 weeks from enrollment

Secondary Outcomes (8)

• Shortened Postpartum Bonding Questionnaire (S-PBQ)

  Baseline (Screening), week 8 and 20 weeks from enrollment

• UCLA 3-Item Loneliness Scale

  Baseline (Screening), week 8 and 20 weeks from enrollment

• Multidimensional Scale of Perceived Social Support (MSPSS)

  Baseline (Screening), Week 8, 20 weeks from enrollment

• Treatment and Story Reflection Questionnaire

  Weeks 2 to 8

• Treatment Satisfaction Questionnaire

  Week 8

Study Arms (1)

Wellbeing Course for New and Expecting Parents

EXPERIMENTAL

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.

Behavioral: Internet-delivered Cognitive Behavioural Therapy

Interventions

Internet-delivered Cognitive Behavioural Therapy BEHAVIORAL

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.

Wellbeing Course for New and Expecting Parents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Become the guardian of an infant in the last 24 month by birth or adoption/fostering or are expecting the birth of an infant as a birthing parent or partner;
• 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.

You may not qualify if:

• Current severe medical or psychiatric condition that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);
• 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).

Sponsors & Collaborators

• University of Regina: lead
• Government of Saskatchewan, Ministry of Health: collaborator
• Macquarie University, Australia: collaborator

Study Sites (1)

Online Therapy Unit

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Links

• Link to the primary unit running the study

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Nugent, MSW

CONTACT

306-337-2946; marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

CONTACT

306-585-5133; heather.hadjistavropoulos@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All clients will be directed to complete the Wellbeing Course for New and Expecting Parents

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)