Recruiting

WCNEP

Sponsor:

University of Regina

Code:

NCT06881693

Conditions

Anxiety

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-delivered Cognitive Behavioural Therapy

Study Details

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

Study ID

NCT06881693

Start date

Feb 24, 2025

Status verified date

Nov, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment ]
  • Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment ]

Central Contacts and Locations

Central contacts

Locations

Online Therapy Unit

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

Principal Investigator:

Heather Hadjistavropoulos, PhD

More Information

Sponsor

University of Regina

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2025-11-17.