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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 ea

Первичные конечные точки

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

Вторичные конечные точки (3)

• Kessler Psychological Distress Scale - 10 items (French) [Срок оценки: Week 0, before each program lesson (intervention group) Week 6, Week 10]
• Assessment of Quality of Life - 6 dimensions (French) [Срок оценки: Week 0, week 6 and week 10]
• Maternal Postnatal Attachment Scale (French) [Срок оценки: Week 0, Week 6 and Week 10]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 4 центра

• Centre intégré de santé et services sociaux de la Montérégie-Ouest — Châteauguay
• Centre intégré de santé et services sociaux de la Montérégie-Est — Greenfield Park
• Centre intégré de santé et services sociaux de la Montérégie-Centre — Longueuil
• Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospital — Sherbrooke

Публикации

• 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 PMID 30877878
• 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. BM PMID 40075340

Идентификаторы

NCT: NCT06778096 · MP-31-2024-5238

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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