CLINICAL TRIAL

1-Day Cognitive Behavioural Therapy-Based Workshop for Depression, Postpartum

Recruiting · 18+ · Female · Hamilton, Canada

Public Health Nurse-Delivered 1-Day CBT Workshops Pilot

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About the trial for Depression, Postpartum

Eligible Conditions
Depression, Postpartum · Postpartum Depression · Depression

Treatment Groups

This trial involves 2 different treatments. 1-Day Cognitive Behavioural Therapy-Based Workshop is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
1-Day Cognitive Behavioural Therapy-Based Workshop
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
have infant <12 months at time of recruitment
fluent in written/spoken English
You must be at least 18 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether 1-Day Cognitive Behavioural Therapy-Based Workshop will improve 4 primary outcomes and 14 other outcomes in patients with Depression, Postpartum. Measurement will happen over the course of 1 week.

Working Alliance Inventory (WAI-SR)
1 WEEK
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.
1 WEEK
Client Satisfaction Questionnaire (CSQ-8)
1 WEEK
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.
1 WEEK
Group cohesion - Therapeutic Factors Inventory - 8 item
1 WEEK
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.
1 WEEK
Development and testing of treatment fidelity measure
12 WEEKS
The fidelity with which the PHNs deliver the 1-Day CBT Workshop will be assessed using measures of adherence and competence. For this pilot study, adherence and competence measures will be developed and tested for use in a later RCT. 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.
12 WEEKS
Number of participants recruited in recruitment period
5 MONTHS
Recruit and randomize 96 participants within 5 months (48 treatment into four 1-day workshops (12 per workshop) and 48 control)
5 MONTHS
GAD-7
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.
6 MONTHS
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Who is running the study

Principal Investigator
R. V. L.
Prof. Ryan Van Lieshout,, MD PhD
McMaster University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes depression, postpartum?

Results from a recent clinical trial, the rate of postpartum depression remained stable between the time intervals (1-3 months, 4-6 months) and (6+months) following delivery.

Anonymous Patient Answer

Can depression, postpartum be cured?

The findings of the current study suggest that even if postpartum depression could be prevented and/or treated adequately, there would still remain a small percentage of women who would remain chronically depressed after childbirth.

Anonymous Patient Answer

How many people get depression, postpartum a year in the United States?

Results from a recent clinical trial indicate a considerable number of depressed women do not get diagnosed during the first postpartum year of their lives. The potential for early detection and effective treatment may be important in decreasing the depression burden in the community.

Anonymous Patient Answer

What are the signs of depression, postpartum?

Signs of depression can appear anytime in the postpartum and could not be identified by mothers. The severity and distress of these signs were greater in patients with depression and lesser in patients without depression.

Anonymous Patient Answer

What are common treatments for depression, postpartum?

This chapter concludes with specific guidelines for postpartum depression. A comprehensive assessment for this disease is recommended from the first postpartum visit for all women and an immediate referral to the appropriate provider is advised for any women who have persistent symptoms or are not appropriately managing their pain.

Anonymous Patient Answer

What is depression, postpartum?

This condition occurs during or after delivery and after delivery to women. During this time women experience symptoms like fear or sadness that may last for several days. Symptoms may include a sense of self-worthlessness or hopelessness and thoughts of suicide or harming oneself or others. Symptoms may vary depending on the baby's birth status and are more common in the first two weeks after delivery. After this initial period of sadness and fear, postpartum depression may be short lived or, if serious, it may not go away but can manifest as depressive features or symptoms.

Anonymous Patient Answer

What is 1-day cognitive behavioural therapy-based workshop?

The workshop was well received, but it had minimal impact on participants. The workshop may be more beneficial in improving knowledge and skills than impacting outcomes. The study will be repeated in an enhanced format to assess how best a workshop can impact outcomes.

Anonymous Patient Answer

What is the latest research for depression, postpartum?

A recent systematic review showed that, to a limited extent, there is evidence of effectiveness for postpartum depression, especially when delivered as part of the standard of care. However, there is insufficient evidence to recommend its routine use. Also, there is limited evidence available regarding antidepressant use or other interventions for postpartum depression.

Anonymous Patient Answer

Is 1-day cognitive behavioural therapy-based workshop safe for people?

The 1-day CBT workshop was well regarded by medical staff, trainees and participants. This demonstrates that the workshops may be a promising treatment modality for the medical health care setting.

Anonymous Patient Answer

Does 1-day cognitive behavioural therapy-based workshop improve quality of life for those with depression, postpartum?

A CBT-based intervention programme provided by a counsellor, tailored to individual requirements, is effective in the treatment of postpartum depression. The intervention programme produced significant improvements in patient QoL. A clinical trial is required to confirm the extent and duration of these benefits and to investigate the cost-effectiveness of the programme.

Anonymous Patient Answer

Who should consider clinical trials for depression, postpartum?

Clinicians should consider trial entry or retention for those who are depressed, either postpartum or not. For those who are satisfied with their care, they may opt to continue treatment regardless of trial entry or retention.

Anonymous Patient Answer

What does 1-day cognitive behavioural therapy-based workshop usually treat?

These preliminary results, limited by small sample size and short treatment duration, suggest that CBT-based workshops may be associated with an improvement in self-rated psychological wellbeing.

Anonymous Patient Answer
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