Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women

NCT06778096 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2025-05-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

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

    collaborator UNKNOWN
  • Centre intégré de santé et services sociaux de la Montérégie-Centre

    collaborator UNKNOWN
  • Centre intégré de santé et services sociaux de la Montérégie-Ouest

    collaborator UNKNOWN
  • Centre intégré de santé et services sociaux de la Montérégie-Est

    collaborator UNKNOWN
  • Champlain Local Health Integration Network

    collaborator UNKNOWN
  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Pasquale Roberge, PhD · Université de Sherbrooke

  • Helen-Maria Vasiliadis, PhD · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778096 on ClinicalTrials.gov