Public Health Nurse-Delivered 1-Day CBT Workshops for PPD

• ClinicalTrials.gov Identifier: NCT05622305
• Recruitment Status: Recruiting
• First Posted: November 18, 2022
• Last Update Posted: November 18, 2022
• Sponsor: McMaster University
• Information provided by (Responsible Party): McMaster University

Study Description

Brief Summary:

Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months.

The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family.

Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.

Condition or disease	Intervention/treatment	Phase
Postpartum Depression	Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop	Not Applicable

Detailed Description:

Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births.

Current clinical practice guidelines recommend evidence-based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st-line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but "only when CBT or other evidence-based counseling is available."

While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level.

The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers' needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1-Day) interventions contain the core content of more comprehensive, evidence-based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1-Day CBT-Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression.

Research Questions:

Primary: Can Online 1-Day CBT-Based Workshops for PPD delivered by Public Health Nurses (PHNs) added to treatment as usual (TAU) improve PPD more than TAU alone at 12 weeks post-treatment? Secondary: Can these workshops improve PPD at 6 months post-treatment and reduce levels of anxiety, parenting stress, partner relationship discord, improve parent-infant attachment, and reduce problems with temperament and behaviour in offspring at 3 and 6 months? Tertiary: Are the workshops cost-effective?

A parallel-group Ontario-wide randomized controlled trial (RCT) with experimental (workshop) and TAU (control) groups will address our objectives. Participants in both groups will complete all study questionnaires and be compared at baseline, and 3 and 6 months.

The experimental group will receive the Online 1-Day workshop (delivered by 2 PHNs) in addition to TAU, and the control group will receive TAU alone.

Participants will be mothers who have an infant under 12 months, who are 18 years or older, who are experiencing elevated symptoms of postpartum depression and who are free of current bipolar, psychotic and/or substance use disorders.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 447 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
• Primary Purpose: Treatment
• Official Title: Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshops for Postpartum Depression: A Randomized Controlled Trial
• Actual Study Start Date: October 11, 2022
• Estimated Primary Completion Date: April 30, 2024
• Estimated Study Completion Date: October 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Online 1-Day CBT-Based Workshop; Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained public health nurses in addition to receiving usual care.	Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop; The Online Workshop is a day-long intervention delivered by two trained public health nurses consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. We also provide a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD.
No Intervention: Treatment as Usual; Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.

Outcome Measures

Primary Outcome Measures :

1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 12 weeks ]
   The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change.

Secondary Outcome Measures :

1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 6 months ]
   The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change.
2. Generalized Anxiety Disorder 7-Item Scale [ Time Frame: 12 weeks and 6 months ]
   The Generalized Anxiety Disorder 7-Item Scale (GAD-7) (32) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. Items are scored on a 4-point scale from 0 to 3, with a higher score indicating an increased risk of GAD. A cutoff of ≥11 defines clinically important levels of anxiety symptoms.
3. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: 12 weeks and 6 months ]
   A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.
4. Parenting Stress Index (PSI-SF) [ Time Frame: 12 weeks and 6 months ]
   The Parenting Stress Index (short form) is a 36-item parent self-report measure that identifies potentially dysfunctional parent-child systems on three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. The measure also produces a total score that is an indication of overall level of stress a person is feeling in their role as a parent. Higher scores indicate higher levels of stress.
5. Postpartum Bonding Questionnaire (PBQ [ Time Frame: 12 weeks and 6 months ]
   The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
6. Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R) [ Time Frame: 12 weeks and 6 months ]
   The Infant Behaviour Questionnaire-Revised (Very Short Form) (IBQR) is a parent-report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assesses 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items, and Orienting/Regulatory Capacity with 12 items; higher scores indicate greater alignment with the domain.
7. EQ-5D-5L [ Time Frame: 12 weeks and 6 months ]
   A utility-based health-related quality of life self-report instrument consisting of five questions covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach).
8. Healthcare Resource Utilization Questionnaire [ Time Frame: 12 weeks and 6 months ]
   Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnoses and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those relating to mental health). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.
9. Mini International Neuropsychiatric Interview - Major Depressive Disorder Module [ Time Frame: 12 weeks and 6 months ]
   10-15 minute structured psychiatric interview will assess current psychiatric syndromes in participants by telephone at baseline to assess study eligibility. The MINI will be conducted again at 3 and 6 months to assess change in psychiatric symptoms over the study period.
10. Mini International Neuropsychiatric Interview - Generalized Anxiety Disorder Module [ Time Frame: 12 weeks and 6 months ]
    10-15 minute structured psychiatric interview will assess current psychiatric syndromes in participants by telephone at baseline to assess study eligibility. The MINI will be conducted again at 3 and 6 months to assess change in psychiatric symptoms over the study period.

Other Outcome Measures:

1. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 1 week post intervention in experimental arm ]
   Intervention participants only. An 8-item scale that measures and assesses consumer satisfaction with health and human services. Items are scored on a 4-point scale and total scores range from 8-32, with higher scores indicating greater satisfaction.
2. CBT Skills Questionnaire (CBTSQ) [ Time Frame: 12 weeks and 6 months in experimental arm ]
   Intervention participants only. A 16-item maternal-report measure designed to assess cognitive and behavioural skills acquisition. Each item is scored on a 5-point scale, and total scores range from 16-80. Higher cognitive restructuring and behavioural activation scores predict reduction of overall psychiatric symptoms and depression.
3. Working Alliance Inventory (WAI-SR) [ Time Frame: 1 week post intervention in experimental arm ]
   Intervention participants only. A 12-item maternal-report measure that assesses three aspects of therapeutic alliance:(1) agreement on the tasks of therapy, (2) agreement on the goals of therapy and (3) development of an affective bond. Items are rated on a 5-point scale, and total scores range from 12-60 with higher scores indicating a better therapeutic alliance.
4. Group cohesion - Therapeutic Factors Inventory - 8 item [ Time Frame: 1 week post intervention in experimental arm ]
   Measured using the Therapeutic Factors Inventory-8 item that measures instillation of hope, secure emotional expression, awareness of relational impact and social learning. Items are scored on a likert-scale ranging from 1-7. Higher scores indicate a more cohesive group.
5. Fidelity of Intervention Delivery [ Time Frame: 12 weeks ]
   The fidelity with which the PHNs deliver the 1-Day CBT Workshop will be assessed using measures of adherence and competence that were developed for evaluating delivery of the 1-Day CBT workshop. Each workshop will be audio-recorded and trained raters will rate the adherence to the workshop model and competence with which the PHNs deliver the workshops.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 18 years or older
• have infant <12 months at time of recruitment
• fluent in written/spoken English

Exclusion Criteria:

• current bipolar, psychotic and/or substance use disorders

Contacts and Locations

Contacts

Contact: Ryan Van Lieshout, MD, PhD; (905)522-1155 ext 35123; vanlierj@mcmaster.ca

Contact: Haley Layton, MPH; 4168430477; laytonh@mcmaster.ca

Locations

Canada, Ontario

McMaster University; Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contact: Ryan Van Lieshout, MD, PhD

Sponsors and Collaborators

McMaster University

Investigators

• Principal Investigator: Ryan Vann Lieshout, MD, PhD; McMaster University

More Information

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT05622305
• Other Study ID Numbers: PHN1DayCBT
• First Posted: November 18, 2022
• Last Update Posted: November 18, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Behavioral Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications