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Trial record 7 of 49 for:    Postpartum Depression AND PPD | "Depression" AND "Depression"

1-Day CBT Workshops for PPD

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ClinicalTrials.gov Identifier: NCT03654261
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ryan Van Lieshout, McMaster University

Brief Summary:
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. The purpose of this pilot study is to successfully adapt and deliver a 1-day CBT workshop for depression to women with PPD, establish the feasibility of a study protocol, and generate an estimate of the treatment effect (as well as its variance) in this population for a later, large-scale study. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 30 women will be randomized to active treatment (n=15) or a 12 week wait list (n=15) in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Cognitive Behavioural Therapy Not Applicable

Detailed Description:

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.

The purpose of this pilot study is to successfully adapt and deliver a 1-day CBT workshop for depression to women with PPD, establish the feasibility of a study protocol, and generate an estimate of the treatment effect (as well as its variance) in this population for a later, large-scale study.

A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 30 women will be randomized to active treatment (n=15) or a 12 week wait list (n=15) in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

If this study can show that a 1-day CBT workshop for PPD can be effectively delivered to women, it would set the stage for the conduct of a larger trial aimed at establishing the effectiveness of delivering this 1-day CBT workshop to women with PPD. If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1-Day CBT Workshop - Immediate
Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart).
Behavioral: Cognitive Behavioural Therapy
The intervention is a 1-day Cognitive Behavioural Therapy based workshop.

Experimental: 1-Day CBT Workshop - Waitlist
Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart).
Behavioral: Cognitive Behavioural Therapy
The intervention is a 1-day Cognitive Behavioural Therapy based workshop.




Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 3 months ]
    EPDS is the 10-item gold standard measure of PPD. A score >10 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change

  2. Beck Depression Inventory-II [ Time Frame: 3 months ]
    The Beck Depression Inventory is a 21-item scale that assesses the emotional and cognitive symptoms of depression as the EPDS does, but additionally captures the somatic symptoms of depression. Higher scores on the BDI-II indicate more sever depression. The minimum score is 0 and maximum score is 63. Items are summed to generate a total score. 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.


Secondary Outcome Measures :
  1. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 3 months ]
    The GAD-7 is a 7-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. The minimum score is 0 and the maximum score is 21. Items are summed to generate a total score. Scores of 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety and 15 or greater indicate severe anxiety.

  2. Postpartum Bonding Questionnaire [ Time Frame: 3 months ]
    Postpartum Bonding Questionnaire is a 25-item maternal report scale that is designed to detect disorders of the mother-infant relationship. Scores range on each question from 0 (Always) to 5 (Never) and are summed to generate subscale scores. The subscales include: impaired bonding, rejection and pathological anger, infant focused anxiety and incipient abuse. Higher scores indicate problems with bonding.

  3. Client Satisfaction Questionnaire [ Time Frame: Immediately after workshop ]
    The Client Satisfaction Questionnaire (CSQ-8) is an 8-item patient reported scale that is designed to measure client satisfaction with services. The Maximum score is 32 and the minimum score is 4. Higher scores indicate greater satisfaction.

  4. Healthcare Utilization [ Time Frame: 3 months ]
    As depression is associated with increased rates of healthcare use, mothers will answer the Health Care Utilization questions of the Canadian Community Health Survey at all time points. Mothers will also answer the General Help-Seeking Questionnaire and the Mental Help Seeking Intention Scale at all time points, in order to measure the likelihood that they will seek help from healthcare professionals.

  5. Infant Behaviour Questionnaire-Revised (Very short form) [ Time Frame: 3 months ]
    To assess infant temperament if infants. The measure takes a mean value of the questions to which a response was provided.

  6. Strengths and Difficulties Questionnaire [ Time Frame: 3 months ]
    To assess temperament of 2-4 year olds. Each response has values of 0, 1 and 2. These are summed to generate a total score for each subscale: Emotional Problems Scale, Conduct Problems Scale, Hyperactivity Scale, Peer Problems Scale, Prosocial Scale. The minimum score for each scale is 0 and the maximum is 10. Higher scores indicate greater difficulties.

  7. Early Childhood Behaviour Questionnaire (very short form) [ Time Frame: 3 months ]
    To assess temperament of children 18-36 months. The subscales include negative affect, surgency and effortful control. The measure takes a mean value of the questions to which a response was provided.

  8. EQ-5D [ Time Frame: 3 months ]
    The EQ-5D, a measure of health-related quality of life will also be completed by mothers. Health status is measured on five dimensions on three-point scales. The associated tariffs for Canada are then applied to calculate quality-adjusted life-years (QALYs). The instrument also includes a visual analogue scale, allowing individuals to rate their current health status on a scale from 0 (worst) to 100 (best).



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

Inclusion Criteria:

  • infant <12 months
  • 18 years or older
  • EPDS score >10

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654261


Contacts
Contact: Ryan Van Lieshout, MD, PhD 905-522-1155 ext 35123 vanlierj@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 Van Lieshout, MD, PhD McMaster University

Responsible Party: Ryan Van Lieshout, Assistant Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University
ClinicalTrials.gov Identifier: NCT03654261     History of Changes
Other Study ID Numbers: 1Day-CBT
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
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

Keywords provided by Ryan Van Lieshout, McMaster University:
Cognitive Therapy
Workshop
Postpartum Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications