Clinical trial NCT06881693: Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
Official title: Optimizing Therapist-guided Internet-delivered Cognitive Behaviour Therapy for New and Expecting Parents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
Internet-delivered cognitive behaviour therapy
Patient stories
Perinatal mental health
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Government of Saskatchewan, Ministry of Health
name: Macquarie University, Australia
First posted: 2025-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All clients will be directed to complete the Wellbeing Course for New and Expecting Parents
Primary purpose: TREATMENT

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.

Detailed description: Depression and anxiety in the perinatal stage are associated with adverse outcomes such as pregnancy and birth complications, developmental impacts on the baby, relationship issues and poor wellbeing with the partner. Despite these challenges, barriers such as stigma and shame, poor understanding and awareness of symptoms, and lack of treatment availability prevent access to treatment.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment
Secondary outcomes:
measure: Shortened Postpartum Bonding Questionnaire (S-PBQ)
timeFrame: Baseline (Screening), week 8 and 20 weeks from enrollment
measure: UCLA 3-Item Loneliness Scale
timeFrame: Baseline (Screening), week 8 and 20 weeks from enrollment
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline (Screening), Week 8, 20 weeks from enrollment
measure: Treatment and Story Reflection Questionnaire
timeFrame: Weeks 2 to 8
measure: Treatment Satisfaction Questionnaire
timeFrame: Week 8
measure: Additional Resources Questionnaire
timeFrame: Week 8
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Baseline (Screening) and week 4
measure: Semi-Structured Interview
timeFrame: After week 8
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: