AnxietypostnataIiCBTNCT06778096
Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
A study testing Postnatal anxiety and depression iCBTprogram in people with Anxiety and Postnatal Depression, run by Université de Sherbrooke at 4 sites in Canada.
Trial summary
This research project aims to examine the acceptability and efficacy of a French-Canadian adaptation of a postnatal anxiety and depression program. The main question it aims to answer is: [1] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Postnatal Depression
- What is being tested?
- Postnatal anxiety and depression iCBTprogram
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 4 sitesCanada
- Study dates
- May 2025to Jul 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Being within 12 months postpartum
- Fluent in spoken and written French
- Self-reported clinical score ≥10 for anxiety and/or depressive symptoms based on the Generalised Anxiety Disorder-7 (GAD-7) and the Edinburgh Postnatal Depression Scale 10-item scale (EPDS)
- Access to a computer/tablet and internet connection
- Agreement to share primary provider contact information
Who cannot join
- Self-reported diagnosis of schizophrenia or bipolar disorder
- Current substance abuse or dependence
- Current use of benzodiazepines
- Beginning psychological therapy (< 4 weeks ago) or medication (< 8 weeks ago) for depression/anxiety
- Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Centre intégré de santé et services sociaux de la Montérégie-Ouest
Châteauguay, Quebec
Helen-Maria Vasiliadis, PhD, 450 466-5000 ext. 3701, Helen-Maria.Vasiliadis@USherbrooke.ca
Alexandra Chapdelaine, PhD, 819-821-8000 ext. 74288, Alexandra.Chapdelaine@USherbrooke.ca
- Recruiting
Centre intégré de santé et services sociaux de la Montérégie-Est
Greenfield Park, Quebec
Helen-Maria Vasiliadis, PhD, 450 466-5000 ext. 3701, Helen-Maria.Vasiliadis@USherbrooke.ca
Alexandra Chapdelaine, PhD, 819-821-8000 ext. 74288, Alexandra.Chapdelaine@USherbrooke.ca
- Recruiting
Centre intégré de santé et services sociaux de la Montérégie-Centre
Longueuil, Quebec, J4V 2H2
Helen-Maria Vasiliadis, PhD, 450 466-5000 ext. 3701, Helen-Maria.Vasiliadis@USherbrooke.ca
Alexandra Chapdelaine, PhD, 819-821-8000 ext. 74288, Alexandra.Chapdelaine@USherbrooke.ca
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5H3
Pasquale Roberge, PhD, 819-821-8000 ext. 73814, Pasquale.Roberge@USherbrooke.ca
Alexandra Chapdelaine, PhD, 819-821-8000 ext. 74288, Alexandra.Chapdelaine@USherbrooke.ca
About this study
This research project aims to examine the acceptability and efficacy of a French-Canadian adaptation of a postnatal anxiety and depression program. The main question it aims to answer is:
[1] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in community-based care for women with anxiety and depressive symptoms, is the iCBT+TAU condition more effective to reduce symptoms than TAU alone?
Read more
Participants will:
postnatal iCBT group -> Answer questionnaires before, after (week 6) and 4 weeks after the intervention (week 10); do the 6-week non-guided iCBT program for anxiety and depressive symptoms during the postnatal period.
Waitlist, TAU group -> Answer questionnaires at enrolment, at week 6 and week 10. Participants will have access to the intervention after they complete their last questionnaires.
Read the detailed description
Background. Nearly 20% of women will be confronted with anxiety or depressive disorders during the perinatal period and this may lead to adverse outcomes for both mother and child. Cognitive behavioural therapy (CBT) is the psychological intervention with the most empirical support for the clinical management of anxiety and depressive disorders. Depression and anxiety frequently occur in women during the perinatal period, and there is growing evidence that internet-delivered CBT (iCBT) could be an acceptable and effective intervention. ThisWayUp iCBT Virtual Clinic in Australia has developed a program for postnatal anxiety and depression. As part of a Québec-Ontario collaboration, this research protocol aims to examine the acceptability and efficacy of a French-Canadian adaptation of the postnatal anxiety and depression program. Methods/Design. The investigators propose to conduct a hybrid type 1 randomized clinical trial and implementation study to replicate the findings of the trial conducted in Australia as well as explore barriers and facilitators to potential large-scale implementation. Treatment and control groups. a) adapted postnatal depression and anxiety iCBT program (3 lessons to complete in six weeks) added to treatment-as-usual (TAU); b) TAU. Participants will include women with possible postnatal depression or anxiety as per the Generalized Anxiety Disorder-7 (GAD-7) or the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome measures will be the GAD-7 and the EPDS. Secondary outcome measures will comprise self-reported instruments to evaluate mother-child experience, postnatal depression, psychological distress, suicidality risk, quality of life, treatment satisfaction and service utilization. Statistical analysis. Statistical analysis will follow intent-to-treat principles. A mixed model regression approach will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of iCBT compared to TAU intervention. Moderation analyses will be performed for three sets of moderators: clinical characteristics, previous treatments and sociodemographic characteristics. Additionally, treatment effect sizes will be calculated with Cohen's d. Discussion. The study will deliver important data of efficacy and acceptability to patients, clinicians, and decision-makers to inform the scaling-up of the postnatal iCBT intervention. The benefits to patients could include timely access to services, improved remission rates and health-related quality of life, better long-term outcomes; and to the healthcare system, policy and decision-makers: improved efficiency, optimization of resources, and this to meet the perinatal women and child needs equitably.
- Conditions
- Anxiety, Postnatal Depression
- Being tested
- Postnatal anxiety and depression iCBTprogram
- Keywords
- Cognitive Behavioral Therapy, Internet, Non-guided, Transdiagnostic, Randomized clinical trial, Anxiety, Depression, Postnatal
- Medical subject headings
- Anxiety Disorders, Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postnatal anxiety and depression iCBTprogramBehavioural
Also called Postnatal iCBT
The overarching goal of this stand-alone program is to introduce women to CBT skills to help manage symptoms of anxiety and depression, such as psychoeducation, cognitive restructuring and problem solving, behavioural activation, graded exposure and relapse prevention. Each lesson is accompanied by practical homework and resources (e.g., medication during breastfeeding, attachment and bonding, information for entourage, sleep, self-care, intrusive thought, problem solving), and is built to be easily generalizable to a broad range of women. The three lessons must be completed within a 6-week period, with up to two weeks to complete each lesson. Participants will be notified of new lessons available via email and text message reminders. There is a 5-day lockout between lessons stopping the participants to complete the next session once a session is completed to ensure that the sessions are completed over multiple weeks to allow for revision and practice.
| Study group | Role | What they receive |
|---|---|---|
| The postnatal anxiety and depression iCBTprogram + TAU | Experimental | Women will have access to the postnatal iCBT program (self-directed) and will have to complete the program over six weeks. They still can have contacts with the healthcare system. Receives: Behavioral: Postnatal anxiety and depression iCBTprogram |
| Treatment-as-usual | No intervention | No restrictions will be imposed regarding usual care. To reflect heterogeneity of health seeking behaviour and mental health practices for anxiety and depressive symptoms in the community during the postpartum period, participants will not be constrained to a prespecified usual care treatment for external validity or have contacts with the healthcare system. Data will be collected on throughout the trial. This group will have a delayed access to the program after they complete their four-week follow-up questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (French)
Used to evaluate postpartum depression. 10 items, 0 to 3 Likert scale, retrospective on the past 7 days. The score varies between 0 and 30, with a higher score indicating more severe symptoms.
Measured: Week 0, Week 6, Week 10
Generalised Anxiety Disorder-7 (French)
Used to evaluate the severity of anxiety symptoms. 7 items, 0 to 3 Likert scale, retrospective on the past 14 days. The score varies between 0 and 21, with a higher score indicating more severe symptoms.
Measured: Week 0, Week 6, Week 10
Secondary outcomes (3)
Kessler Psychological Distress Scale - 10 items (French)
Used to evaluate psychological distress. 10 items, 1 to 5 Likert scale, retrospective on the past 14 days. The score varies between 10 and 50, with a higher score indicating more psychological distress.
Measured: Week 0, before each program lesson (intervention group) Week 6, Week 10
Assessment of Quality of Life - 6 dimensions (French)
20-item self-administered health-related quality of life tool, retrospective over the past week, to be rated on Likert scales with varying number of levels. It assesses six dimensions: independent living, mental health, coping, relationships, pain, senses. Response options for each item range from 4-6 levels. Scores on each domain and a total score can be derived. Standardized scores range from 0 to 100 where higher scores indicate less quality of life impairment.
Measured: Week 0, week 6 and week 10
Maternal Postnatal Attachment Scale (French)
19-item self-report questionnaire to assess the affective aspect of mother-infant bonding over the past 2 weeks. It is based on three subscales: absence of hostility, pleasure in interaction and quality of attachment. The score varies between 19 and 95; lower scores indicate more problematic responses.
Measured: Week 0, Week 6 and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startMay 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a hybrid type 1 effectiveness-implementation study. The clinical trial is a two-arm parallel group multicentre pragmatic superiority RCT, with allocation at the level of the individual. This study is an adaptation that will follow the original postnatal anxiety and depression iCBT program clinical trial (Loughnan et al., 2019). The proposed trial is congruent with CONSORT recommendations for RCTs and nonpharmacological treatments. The postnatal iCBT program will be offered to participants in the TAU condition at the end of the four-week follow-up (delayed-intervention).
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke, Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Centre intégré de santé et services sociaux de la Montérégie-Ouest, Centre intégré de santé et services sociaux de la Montérégie-Est, Champlain Local Health Integration Network
- Responsible party
- Sponsor
- Investigators
- Pasquale Roberge, PhD, Principal investigator, Université de SherbrookeHelen-Maria Vasiliadis, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778096
- Sponsor's protocol ID
- MP-31-2024-5238
- Acronym
- postnataIiCBT
- Status last verified
- May 2025
- First submitted
- 23 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during the current study will not be publicly available due to ethics committee regulations, but will be available from the corresponding author on reasonable request.
Publications
Loughnan SA, Butler C, Sie AA, Grierson AB, Chen AZ, Hobbs MJ, Joubert AE, Haskelberg H, Mahoney A, Holt C, Gemmill AW, Milgrom J, Austin MP, Andrews G, Newby JM. A randomised controlled trial of 'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women. Behav Res Ther. 2019 May;116:94-103. doi: 10.1016/j.brat.2019.03.001. Epub 2019 Mar 8. No abstract available.
PubMed 30877878Roberge P, Vasiliadis HM, Chapdelaine A, Battista MC, Beaulieu MC, Chomienne MH, Cumyn A, Drapeau M, Durand C, Girard A, Gosselin D, Grenier J, Hardy I, Hudon C, Koszycki D, Labelle R, Lesage A, Lussier MT, Mahoney A, Provencher MD, Shiner CT. Transdiagnostic internet cognitive behavioural therapy for anxiety and depressive symptoms in postnatal women: protocol of a randomized controlled trial. BMC Psychiatry. 2025 Mar 13;25(1):237. doi: 10.1186/s12888-025-06636-3.
PubMed 40075340
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
- ClinicalTrials.gov ID
- NCT06778096
- Acronym / sponsor ID
- postnataIiCBT / MP-31-2024-5238
- Conditions
- Anxiety, Postnatal Depression
- Keywords
- Cognitive Behavioral Therapy, Internet, Non-guided, Transdiagnostic, Randomized clinical trial, Anxiety, Depression, Postnatal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke, Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Centre intégré de santé et services sociaux de la Montérégie-Ouest, Centre intégré de santé et services sociaux de la Montérégie-Est, Champlain Local Health Integration Network
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Jan 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 research project aims to examine the acceptability and efficacy of a French-Canadian adaptation of a postnatal anxiety and depression program. The main question it aims to answer is:
[1] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in community-based care for women with anxiety and depressive symptoms, is the iCBT+TAU condition more effective to reduce symptoms than TAU alone?
Participants will:
postnatal iCBT group -> Answer questionnaires before, after (week 6) and 4 weeks after the intervention (week 10); do the 6-week non-guided iCBT program for anxiety and depressive symptoms during the postnatal period.
Waitlist, TAU group -> Answer questionnaires at enrolment, at week 6 and week 10. Participants will have access to the intervention after they complete their last questionnaires.
Detailed description
Background. Nearly 20% of women will be confronted with anxiety or depressive disorders during the perinatal period and this may lead to adverse outcomes for both mother and child. Cognitive behavioural therapy (CBT) is the psychological intervention with the most empirical support for the clinical management of anxiety and depressive disorders. Depression and anxiety frequently occur in women during the perinatal period, and there is growing evidence that internet-delivered CBT (iCBT) could be an acceptable and effective intervention. ThisWayUp iCBT Virtual Clinic in Australia has developed a program for postnatal anxiety and depression. As part of a Québec-Ontario collaboration, this research protocol aims to examine the acceptability and efficacy of a French-Canadian adaptation of the postnatal anxiety and depression program. Methods/Design. The investigators propose to conduct a hybrid type 1 randomized clinical trial and implementation study to replicate the findings of the trial conducted in Australia as well as explore barriers and facilitators to potential large-scale implementation. Treatment and control groups. a) adapted postnatal depression and anxiety iCBT program (3 lessons to complete in six weeks) added to treatment-as-usual (TAU); b) TAU. Participants will include women with possible postnatal depression or anxiety as per the Generalized Anxiety Disorder-7 (GAD-7) or the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome measures will be the GAD-7 and the EPDS. Secondary outcome measures will comprise self-reported instruments to evaluate mother-child experience, postnatal depression, psychological distress, suicidality risk, quality of life, treatment satisfaction and service utilization. Statistical analysis. Statistical analysis will follow intent-to-treat principles. A mixed model regression approach will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of iCBT compared to TAU intervention. Moderation analyses will be performed for three sets of moderators: clinical characteristics, previous treatments and sociodemographic characteristics. Additionally, treatment effect sizes will be calculated with Cohen's d. Discussion. The study will deliver important data of efficacy and acceptability to patients, clinicians, and decision-makers to inform the scaling-up of the postnatal iCBT intervention. The benefits to patients could include timely access to services, improved remission rates and health-related quality of life, better long-term outcomes; and to the healthcare system, policy and decision-makers: improved efficiency, optimization of resources, and this to meet the perinatal women and child needs equitably.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a hybrid type 1 effectiveness-implementation study. The clinical trial is a two-arm parallel group multicentre pragmatic superiority RCT, with allocation at the level of the individual. This study is an adaptation that will follow the original postnatal anxiety and depression iCBT program clinical trial (Loughnan et al., 2019). The proposed trial is congruent with CONSORT recommendations for RCTs and nonpharmacological treatments. The postnatal iCBT program will be offered to participants in the TAU condition at the end of the four-week follow-up (delayed-intervention).
| Arm | Type | Receives |
|---|---|---|
| The postnatal anxiety and depression iCBTprogram + TAU | Experimental | Behavioral: Postnatal anxiety and depression iCBTprogramWomen will have access to the postnatal iCBT program (self-directed) and will have to complete the program over six weeks. They still can have contacts with the healthcare system. |
| Treatment-as-usual | No intervention | –No restrictions will be imposed regarding usual care. To reflect heterogeneity of health seeking behaviour and mental health practices for anxiety and depressive symptoms in the community during the postpartum period, participants will not be constrained to a prespecified usual care treatment for external validity or have contacts with the healthcare system. Data will be collected on throughout the trial. This group will have a delayed access to the program after they complete their four-week follow-up questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- Being within 12 months postpartum
- Fluent in spoken and written French
- Self-reported clinical score ≥10 for anxiety and/or depressive symptoms based on the Generalised Anxiety Disorder-7 (GAD-7) and the Edinburgh Postnatal Depression Scale 10-item scale (EPDS)
- Access to a computer/tablet and internet connection
Key exclusion criteria (5 listed)
- Self-reported diagnosis of schizophrenia or bipolar disorder
- Current substance abuse or dependence
- Current use of benzodiazepines
- Beginning psychological therapy (< 4 weeks ago) or medication (< 8 weeks ago) for depression/anxiety
- Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)
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 |
|---|---|---|
| Postnatal anxiety and depression iCBTprogramAlso: Postnatal iCBTThe overarching goal of this stand-alone program is to introduce women to CBT skills to help manage symptoms of anxiety and depression, such as psychoeducation, cognitive restructuring and problem solving, behavioural activation, graded exposure and relapse prevention. Each lesson is accompanied by practical homework and resources (e.g., medication during breastfeeding, attachment and bonding, information for entourage, sleep, self-care, intrusive thought, problem solving), and is built to be easily generalizable to a broad range of women. The three lessons must be completed within a 6-week period, with up to two weeks to complete each lesson. Participants will be notified of new lessons available via email and text message reminders. There is a 5-day lockout between lessons stopping the participants to complete the next session once a session is completed to ensure that the sessions are completed over multiple weeks to allow for revision and practice. | Behavioural | The postnatal anxiety and depression iCBTprogram + TAU |
Primary outcome
Edinburgh Postnatal Depression Scale (French)
Time frame: Week 0, Week 6, Week 10
Used to evaluate postpartum depression. 10 items, 0 to 3 Likert scale, retrospective on the past 7 days. The score varies between 0 and 30, with a higher score indicating more severe symptoms.
Generalised Anxiety Disorder-7 (French)
Time frame: Week 0, Week 6, Week 10
Used to evaluate the severity of anxiety symptoms. 7 items, 0 to 3 Likert scale, retrospective on the past 14 days. The score varies between 0 and 21, with a higher score indicating more severe symptoms.
3 secondary outcomes
Kessler Psychological Distress Scale - 10 items (French)
Time frame: Week 0, before each program lesson (intervention group) Week 6, Week 10
Assessment of Quality of Life - 6 dimensions (French)
Time frame: Week 0, week 6 and week 10
Maternal Postnatal Attachment Scale (French)
Time frame: Week 0, Week 6 and Week 10
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 13 May 2025.
- Background: PubMed 30877878Loughnan SA, Butler C, Sie AA, Grierson AB, Chen AZ, Hobbs MJ, Joubert AE, Haskelberg H, Mahoney A, Holt C, Gemmill AW, Milgrom J, Austin MP, Andrews G, Newby JM. A randomised controlled trial of 'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women. Behav Res Ther. 2019 May;116:94-103. doi: 10.1016/j.brat.2019.03.001. Epub 2019 Mar 8. No abstract available.
- Derived from this study: PubMed 40075340Roberge P, Vasiliadis HM, Chapdelaine A, Battista MC, Beaulieu MC, Chomienne MH, Cumyn A, Drapeau M, Durand C, Girard A, Gosselin D, Grenier J, Hardy I, Hudon C, Koszycki D, Labelle R, Lesage A, Lussier MT, Mahoney A, Provencher MD, Shiner CT. Transdiagnostic internet cognitive behavioural therapy for anxiety and depressive symptoms in postnatal women: protocol of a randomized controlled trial. BMC Psychiatry. 2025 Mar 13;25(1):237. doi: 10.1186/s12888-025-06636-3.
- Individual participant dataSharing planned: No. The datasets generated during the current study will not be publicly available due to ethics committee regulations, but will be available from the corresponding author on reasonable request.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Pasquale Roberge, PhD principal investigator
Université de Sherbrooke
Helen-Maria Vasiliadis, PhD principal investigator
Université de Sherbrooke
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postnatal anxiety and depression iCBTprogram in people with Anxiety and Postnatal Depression, run by Université de Sherbrooke at 4 sites 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 6 inclusion and 5 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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Pasquale Roberge, PhD (819 821-8000 ext. 73814, Pasquale.Roberge@USherbrooke.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 (French) (time frame: Week 0, Week 6, Week 10). 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?
On the ClinicalTrials.gov record for NCT06778096, which also lists 2 linked publications.
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 13 May 2025.