Anxiety, Postnatal Depression
Conditions
Keywords
Cognitive Behavioral Therapy, Internet, Non-guided, Transdiagnostic, Randomized clinical trial, Anxiety, Depression, Postnatal
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.
Interventions
BEHAVIORALPostnatal 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
Canadian Institutes of Health Research (CIHR)
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Centre intégré de santé et services sociaux de la Montérégie-Centre
Centre intégré de santé et services sociaux de la Montérégie-Ouest
Centre intégré de santé et services sociaux de la Montérégie-Est
Champlain Local Health Integration Network
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and research coordinator will not be blinded in regard to the participants group allocation.
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale (French) | Week 0, Week 6, Week 10 | 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. |
| Generalised Anxiety Disorder-7 (French) | Week 0, Week 6, Week 10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Quality of Life - 6 dimensions (French) | Week 0, week 6 and week 10 | 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. |
| Kessler Psychological Distress Scale - 10 items (French) | Week 0, before each program lesson (intervention group) Week 6, Week 10 | 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. |
| Maternal Postnatal Attachment Scale (French) | Week 0, Week 6 and Week 10 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale | Week 6 | 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. |
| 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) | 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. |
| Client Satisfaction Questionnaire (8-item French version) | Week 6 | 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. |
Countries
Canada
Contacts
Primary ContactPasquale Roberge, PhD
Backup ContactAlexandra Chapdelaine, PhD
Outcome results
None listed