AnxietyNCT06881693
Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
A study testing Internet-delivered Cognitive Behavioural Therapy in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Internet-delivered Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Online Therapy Unit
Regina, Saskatchewan, S4S 0A2
Marcie Nugent, MSW, 306-337-2946, marcie.nugent@uregina.ca
Heather Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca
About this study
Official title: Optimizing Therapist-guided Internet-delivered Cognitive Behaviour Therapy for New and Expecting Parents
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Internet-delivered Cognitive Behavioural Therapy
- Keywords
- Anxiety, Depression, Internet-delivered cognitive behaviour therapy, Patient stories, Perinatal mental health
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Internet-delivered Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment
Secondary outcomes (8)
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.
Measured: Baseline (Screening), week 8 and 20 weeks from enrollment
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.
Measured: Baseline (Screening), week 8 and 20 weeks from enrollment
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.
Measured: Baseline (Screening), Week 8, 20 weeks from enrollment
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.
Measured: Weeks 2 to 8
Treatment Satisfaction Questionnaire
A 15-item questionnaire used to assess satisfaction with treatment and negative effects experienced by clients during treatment. The questionnaire utilizes a combination of Likert-scale (5-point (0-4)and 6-point (0-5) ), open-ended, and dichotomous yes/no response options to gauge participants' perception of the course. The questionnaire has been developed by the research team and does not have scoring at this time.
Measured: Week 8
Additional Resources Questionnaire
A 4-item measure of clients' opinions of and satisfaction with the 11 additional resources offered alongside the Wellbeing Course for New and Expecting Parents. The questionnaire utilizes a combination of dichotomous yes/no (1-item), checklist (2-items), and open-ended (1-item) response option to understand which additional resources participants reviewed and their perception of the resources. The questionnaire was developed by the research team and no score is calculated or created.
Measured: Week 8
Credibility/Expectancy Questionnaire (CEQ)
Measures treatment credibility and expectancy using 6 items, with two subscales. Each subscale contains 3-items. The first three items of the scale (credibility subscale) are measured on a 1-9 point Likert scale, with scores ranging from 3 to 27 on this subscale. The three items of the expectancy subscale are measured on a 9-point Likert scale ranging from 1 to 9. These items are summed to produce a subscale score ranging from 1 to 27. Higher scores in each sub-scale indicate greater treatment credibility or treatment expectancy respectively.
Measured: Baseline (Screening) and week 4
Semi-Structured Interview
A semi-structured interview to gather feedback on the treatment and specific treatment components (i.e., patient stories). The number of participants to be interviewed will be determined based on the saturation of themes yielded within preliminary qualitative analyses. The semi-structured interview questions were developed by the research team.
Measured: After week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start24 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All clients will be directed to complete the Wellbeing Course for New and Expecting Parents
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Saskatchewan, Ministry of Health, Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881693
- Sponsor's protocol ID
- 985
- Status last verified
- Nov 2026
- First submitted
- 11 Mar 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Therapist-guided Internet-delivered Cognitive Behaviour Therapy for New and Expecting Parents
- ClinicalTrials.gov ID
- NCT06881693
- Acronym / sponsor ID
- 985
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Internet-delivered cognitive behaviour therapy, Patient stories, Perinatal mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Government of Saskatchewan, Ministry of Health, Macquarie University, Australia
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All clients will be directed to complete the Wellbeing Course for New and Expecting Parents
| Arm | Type | Receives |
|---|---|---|
| Wellbeing Course for New and Expecting Parents | Experimental | Behavioral: Internet-delivered Cognitive Behavioural TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered Cognitive Behavioural TherapyThe 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. | Behavioural | Wellbeing Course for New and Expecting Parents |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment
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.
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment
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.
8 secondary outcomes
Shortened Postpartum Bonding Questionnaire (S-PBQ)
Time frame: Baseline (Screening), week 8 and 20 weeks from enrollment
UCLA 3-Item Loneliness Scale
Time frame: Baseline (Screening), week 8 and 20 weeks from enrollment
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline (Screening), Week 8, 20 weeks from enrollment
Treatment and Story Reflection Questionnaire
Time frame: Weeks 2 to 8
Treatment Satisfaction Questionnaire
Time frame: Week 8
Additional Resources Questionnaire
Time frame: Week 8
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Baseline (Screening) and week 4
Semi-Structured Interview
Time frame: After week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Link to the primary unit running the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive Behavioural Therapy in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcie Nugent, MSW (306-337-2946, marcie.nugent@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) (time frame: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.