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Feedback Arm 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 0-6

Awards & highlights

PCMBC Trial Summary

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

Eligible Conditions

Depression

PCMBC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Meaningful change in treatment

Total score QIDS-SR

Secondary outcome measures

EQ-5D

LEAPS

Montgomery Asberg Depression Rating Scale (MADRS)

+2 more

PCMBC 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor

257 Previous Clinical Trials

83,510 Total Patients Enrolled

9 Trials studying Depression

32,146 Patients Enrolled for Depression

Rudolf Uher, MD, PhDPrincipal InvestigatorNova Scotia Health Authority

4 Previous Clinical Trials

30,580 Total Patients Enrolled

3 Trials studying Depression

30,460 Patients Enrolled for Depression

Frequently Asked Questions

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

Is the research team currently seeking participants for this trial?

"As displayed on clinicaltrials.gov, the recruitment process for this study is ongoing. The trial was first launched back in September of 2017 and has been revised as recently as February 6th, 2023."

Answered by AI

What is the upper-limit of participants for this clinical trial?

"Affirmative. According to the clinicaltrials.gov entry, this medical trial is actively looking for volunteers and was initially published on September 10th 2017 before being updated most recently on February 6th 2023. This research project requires a total of 304 subjects from 1 location."

Answered by AI

What are the primary goals of this research endeavor?

"This medical trial intends to measure the Total score QIDS-SR over a six month period. It also takes into account quality of life with the EQ-5D, depression levels via MADRS, and daily functioning through WSAS as secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feedback to Improve Depression Outcomes

Rudolf Uher 2017. "Feedback to Improve Depression Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03162211.