Clinical trial NCT06778096: Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
Official title: Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Postnatal Depression
Keywords: Cognitive Behavioral Therapy
Internet
Non-guided
Transdiagnostic
Randomized clinical trial
Anxiety
Depression
Postnatal
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
name: Centre intégré de santé et services sociaux de la Montérégie-Centre
name: Centre intégré de santé et services sociaux de la Montérégie-Ouest
name: Centre intégré de santé et services sociaux de la Montérégie-Est
name: Champlain Local Health Integration Network
First posted: 2025-01-16
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (French)
timeFrame: Week 0, Week 6, Week 10
measure: Generalised Anxiety Disorder-7 (French)
timeFrame: Week 0, Week 6, Week 10
Secondary outcomes:
measure: Kessler Psychological Distress Scale - 10 items (French)
timeFrame: Week 0, before each program lesson (intervention group) Week 6, Week 10
measure: Assessment of Quality of Life - 6 dimensions (French)
timeFrame: Week 0, week 6 and week 10
measure: Maternal Postnatal Attachment Scale (French)
timeFrame: Week 0, Week 6 and Week 10
Other outcomes:
measure: Client Satisfaction Questionnaire (8-item French version)
timeFrame: Week 6
measure: System Usability Scale
timeFrame: Week 6
measure: Past health service utilization
timeFrame: 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)
Locations:
city: Châteauguay
country: Canada
facility: Centre intégré de santé et services sociaux de la Montérégie-Ouest
state: Quebec
city: Greenfield Park
country: Canada
facility: Centre intégré de santé et services sociaux de la Montérégie-Est
state: Quebec
city: Longueuil
country: Canada
facility: Centre intégré de santé et services sociaux de la Montérégie-Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Pasquale Roberge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Helen-Maria Vasiliadis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.