Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversité de Sherbrooke
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Postnatal anxiety and depression iCBTprogram
BehavioralThe 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.
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: The postnatal anxiety and depression iCBTprogram + TAUExperimental treatment 1 intervention
Group B: Treatment-as-usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 0, Week 6, Week 102
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.
Time frame
Week 0, Week 6, Week 10Secondary outcomes
1
Kessler Psychological Distress Scale - 10 items (French)
Used to evaluate psychological distress. 10 items, 1 to 5 Likert scale, retrospective on the past 14 days. The score varies between 10 and 50, with a higher score indicating more psychological distress.
Time frame
Week 0, before each program lesson (intervention group) Week 6, Week 102
Assessment of Quality of Life - 6 dimensions (French)
20-item self-administered health-related quality of life tool, retrospective over the past week, to be rated on Likert scales with varying number of levels. It assesses six dimensions: independent living, mental health, coping, relationships, pain, senses. Response options for each item range from 4-6 levels. Scores on each domain and a total score can be derived. Standardized scores range from 0 to 100 where higher scores indicate less quality of life impairment.
Time frame
Week 0, week 6 and week 103
Maternal Postnatal Attachment Scale (French)
19-item self-report questionnaire to assess the affective aspect of mother-infant bonding over the past 2 weeks. It is based on three subscales: absence of hostility, pleasure in interaction and quality of attachment. The score varies between 19 and 95; lower scores indicate more problematic responses.
Time frame
Week 0, Week 6 and Week 10Other outcomes
1
Client Satisfaction Questionnaire (8-item French version)
Tool for evaluating client's satisfaction with a service. It consists of eight items to be evaluated on a 4-point Likert scale. The score varies between 8 and 32, with a higher score indicating greater satisfaction.
Time frame
Week 62
System Usability Scale
It measures the efficiency of a system as well as its effectiveness perceived by users and also their satisfaction. The scale goes from 0 to 100, where a higher score indicates higher usability.
Time frame
Week 63
Past health service utilization
Visits with health professionals (number, type of professionnals), previous psychotherapy for anxiety or depression (yes/no, additional true/false questions about the psychotherapy they received), medication (name). These data will be used for descriptive analysis or control variables.
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Université de Sherbrooke
Lead sponsor
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 de 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
Source ClinicalTrials.gov