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Feedback Reports for Depression (PCMBC Trial)

N/A

Recruiting

Led By Rudolf Uher, MD, PhD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

capacity to provide informed consent

a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 0-6

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to investigate how giving personalized feedback to patients & clinicians can improve care & outcomes for people with depression in Canada.

Who is the study for?

This trial is for adults with a diagnosis of Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD), where depression is their main issue. They must be able to consent and not have bipolar, schizophrenia, current substance abuse issues, acute suicide risk, or be pregnant.

What is being tested?

The study tests if personalized feedback reports to patients and clinicians can improve care for depression. Participants are split into two groups: one receives feedback based on questionnaire responses; the other does not. The impact on symptoms and healthcare costs will be tracked.

What are the potential side effects?

Since this trial involves providing feedback rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort when discussing personal information in questionnaires.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I understand and can agree to the study's procedures and risks.

Select...

I have been diagnosed with major depression or persistent depressive disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 0-6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 0-6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 0-6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Meaningful change in treatment

Total score QIDS-SR

Secondary study objectives

EQ-5D

LEAPS

Montgomery Asberg Depression Rating Scale (MADRS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Feedback ArmExperimental Treatment1 Intervention

A registry platform including access to all self-report rating scales and the feedback mechanism will be made available to all patients. Patients in the experimental group will receive automated reminders (by text message, phone and/or email) to complete outcome measures each week. Feedback forms will be comprehensive and condensed to a one page report including graphical presentations of symptom course and text. Clinician feedback forms will include content on depression severity over time and recommendations for individualized treatment. Patient feedback forms will also incorporate depression severity over time as well as summary information on achievement towards personalized treatment goals. The intervention will last 6-months, with feedback forms being generated once per week for the first three month and then each month for a total of fifteen feedback time points. Patients in the feedback group will be encouraged to meet with their clinician each month to discuss the feedback.

Group II: No Feedback ArmActive Control1 Intervention

A registry platform including access to all self-report rating scales and the feedback mechanism will be made available to all patients. Patients in the control group will not receive regular reminders or be sent feedback reports on an automatic regular basis.

0 / 2Eligibility criteria met