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

NCT06778096 | Recruiting DMC

• 1 other identifier: MP-31-2024-5238
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 0, Week 6, Week 10

Secondary Outcomes (3)

• Kessler Psychological Distress Scale - 10 items (French)

  Week 0, before each program lesson (intervention group) Week 6, Week 10

• Assessment of Quality of Life - 6 dimensions (French)

  Week 0, week 6 and week 10

• Maternal Postnatal Attachment Scale (French)

  Week 0, Week 6 and Week 10

Other Outcomes (3)

• Client Satisfaction Questionnaire (8-item French version)

  Week 6

• System Usability Scale

  Week 6

• Past health service utilization

  Week 0 (baseline, retrospective on the past 3 months), Week 6 (post-treatment, retrospective on the past 6 weeks), Week 10 (follow-up, retrospective on the past 4 weeks)

Study Arms (2)

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.

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.

Interventions

Postnatal anxiety and depression iCBTprogram BEHAVIORAL

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.

Also known as: Postnatal iCBT

The postnatal anxiety and depression iCBTprogram + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke: collaborator
• Centre intégré de santé et services sociaux de la Montérégie-Centre: collaborator
• Centre intégré de santé et services sociaux de la Montérégie-Ouest: collaborator
• Centre intégré de santé et services sociaux de la Montérégie-Est: collaborator
• Champlain Local Health Integration Network: collaborator

Study Sites (4)

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

Châteauguay, Quebec, Canada

RECRUITING

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

Greenfield Park, Quebec, Canada

RECRUITING

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

Longueuil, Quebec, J4V 2H2, Canada

RECRUITING

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

Sherbrooke, Quebec, J1H5H3, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 30877878 BACKGROUND

• Roberge 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.

  PMID: 40075340 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Pasquale Roberge, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Helen-Maria Vasiliadis, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pasquale Roberge, PhD

CONTACT

819 821-8000; Pasquale.Roberge@USherbrooke.ca

Alexandra Chapdelaine, PhD

CONTACT

819-821-8000; Alexandra.Chapdelaine@USherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and research coordinator will not be blinded in regard to the participants group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 16, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)