Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Internet-delivered Cognitive Behavioural Therapy
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Wellbeing Course for New and Expecting ParentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Screening), weeks 1-8, and 20 weeks from enrollment2
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.
Time frame
Baseline (Screening), weeks 1-8, and 20 weeks from enrollmentSecondary outcomes
1
Shortened Postpartum Bonding Questionnaire (S-PBQ)
Tracking the change in postnatal birthing parents' bonding with their baby. 10 items are measured on a 5-point Likert scale, ranging from 1-5. Scores are summed into a total score ranging from 10 to 50, with higher scores indicating greater self-reported difficulties in bonding with baby. Administered to postnatal parents only.
Time frame
Baseline (Screening), week 8 and 20 weeks from enrollment2
UCLA 3-Item Loneliness Scale
Measures loneliness. 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating higher levels of perceived loneliness.
Time frame
Baseline (Screening), week 8 and 20 weeks from enrollment3
Multidimensional Scale of Perceived Social Support (MSPSS)
A 12-item measure with three subscales measuring perceived social support from friends, family and significant other. Each subscale contains 4-items. Items on each subscale are measured on a 7-point Likert scale, ranging from 1-7. Subscale scores range from 4 to 28 each, with higher scores indicating greater perceived social support in each category. Global scores range from 12 to 84, with higher scores indicating greater perceived social support overall.
Time frame
Baseline (Screening), Week 8, 20 weeks from enrollment4
Treatment and Story Reflection Questionnaire
Measures clients' week-to-week experience in the Wellbeing Course for New and Expecting Parents, and feedback on patient stories. This 10-item measure has been developed by the research team, and contains three subscales. Three items measured on a 7-point Likert scale ranging from 1-7 will be summed into a total score between 3 to 21 to reflect engagement with the treatment, with higher scores indicating greater engagement. Four items (three measured on an 8-point Likert scale ranging from 0-7, and one measured on a 6-point Likert scale ranging from 0-5) will be summed into a total score between 0 to 26 to reflect engagement with patient stories over the past week. Higher scores indicate greater engagement with patient stories. The remaining three items do not have a sum scores, and are used to inquire about which lesson and resources clients worked on, and client success and challenges over the previous week.
Time frame
Weeks 2 to 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regina
Lead sponsor
Government of Saskatchewan, Ministry of Health
Collaborator
Macquarie University, Australia
Collaborator
Source ClinicalTrials.gov