Recruiting

Cognitive-Behavior Therapy

Sponsor:

Université de Sherbrooke

Code:

NCT06778096

Conditions

Anxiety

Postnatal Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Postnatal anxiety and depression iCBTprogram

Study Details

Brief 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 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.

Conditions

Anxiety

Postnatal Depression

Study ID

NCT06778096

Start date

May, 2025

Status verified date

May, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

226 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The postnatal anxiety and depression iCBTprogram + TAU

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.

no intervention: Treatment-as-usual

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.

Interventions

Postnatal anxiety and depression iCBTprogram

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.

Primary outcome measure

  • Edinburgh Postnatal Depression Scale (French) [ Time Frame: Week 0, Week 6, Week 10 ]
  • Generalised Anxiety Disorder-7 (French) [ Time Frame: Week 0, Week 6, Week 10 ]

Central Contacts and Locations

Central contacts

Locations

Centre intégré de santé et services sociaux de la Montérégie-Ouest

Recruiting

Châteauguay, Quebec, Canada

Contacts

Principal Investigator:

Helen-Maria Vasiliadis, PhD

Centre intégré de santé et services sociaux de la Montérégie-Est

Recruiting

Greenfield Park, Quebec, Canada

Contacts

Principal Investigator:

Helen-Maria Vasiliadis, PhD

Centre intégré de santé et services sociaux de la Montérégie-Centre

Recruiting

Longueuil, Quebec, Canada, J4V 2H2

Contacts

Principal Investigator:

Helen-Maria Vasiliadis, PhD

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H5H3

Contacts

Principal Investigator:

Pasquale Roberge, PhD

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • Cognitive Behavioral Therapy
  • Internet
  • Non-guided
  • Transdiagnostic
  • Randomized clinical trial
  • Anxiety
  • Depression
  • Postnatal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-05-13.