Feedback Reports for Depression

(PCMBC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Rudolf Uher, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nova Scotia Health Authority

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Depression is a leading cause of burden in Canada and globally. Although more people now seek and receive treatment for depression, there are still many who do not respond well to treatments. New and low-cost options are needed to improve the lives of people with depression. Research suggests that asking patients to complete questionnaires and sending feedback to their clinicians may improve depressive symptoms. Research also shows that encouraging individuals with depression to take part in shaping their own care can be beneficial. To date, no research has examined a combination of these two approaches. This project aims to investigate the benefits of providing personalized feedback to patients and clinicians in order to improve the care and outcomes for people with depression in Canada. To answer this research question, adults who are diagnosed with depression will be placed in one of two groups: 1. The patient and clinician will receive feedback to help guide further care based on the patient's responses to questionnaires 2. The patient and clinician will not receive feedback. The feedback form has been developed with input from clinicians, researchers and people with lived experience of depression, and follows new Canadian treatment guidelines. Information including depressive symptoms, quality of life, personal goals for recovery, and healthcare costs will be collected for a year or longer using an online data collection platform. The research team includes clinician-scientists, healthcare managers, educators, primary care physician and people with lived experience of depression. This project has the potential to deliver significant health benefits for individuals with depression, lessen the population burden of depression and improve the health care system by optimizing care delivery and improving quality of life at low cost.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing feedback to improve care, so it's likely you can continue your current treatment, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Feedback Report, Personalized Feedback, Patient-Targeted Feedback for depression?

Research indicates that providing feedback and treatment advice for depression to primary care physicians through electronic systems can improve the quality of care and clinical outcomes for patients with major depression. ^{1 2 3 4 5}

How does the feedback report treatment for depression differ from other treatments?

The feedback report treatment for depression is unique because it involves providing personalized feedback to patients and their doctors about the severity of depression, which can improve treatment decisions and patient engagement. This approach focuses on communication and tailored feedback rather than medication or traditional therapy methods. ^{2 5 6 7 8}

Research Team

Rudolf Uher, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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.

Inclusion Criteria

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

I am 18 years old or older.

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

Exclusion Criteria

You are pregnant.

You have a high risk of attempting suicide based on a depression rating scale.

You are currently experiencing symptoms of psychosis (loss of touch with reality, hallucinations, delusions, etc.).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive person-centered measurement-based feedback for depression management

6 months

Weekly feedback for 3 months, then monthly feedback

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Feedback Report (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Feedback Arm Experimental Treatment 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Karen Oldfield

Nova Scotia Health Authority

Chief Executive Officer since 2021

Past Chair of the Board of Governors of Saint Mary’s University

Dr. Robert Strang

Nova Scotia Health Authority

Chief Medical Officer

MD

Findings from Research

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

A study involving 308 participants with subclinical depression demonstrated that a conversational agent can effectively collect thought record data, making it feasible for patients to engage in cognitive therapy techniques.

Participants preferred discussing interpersonal situations over achievement-related ones, highlighting the importance of social contexts in their thought processes, but providing richer feedback did not increase motivation for recording thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a conversational agent for thought recording as a cognitive therapy task: Feasibility, content, and feedback. Burger, F., Neerincx, MA., Brinkman, WP.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The electronic medical record. A randomized trial of its impact on primary care physicians' initial management of major depression [corrected]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized trial using computerized decision support to improve treatment of major depression in primary care. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Can assessing chronic pain outcomes data improve outcomes? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of communicating depression severity on physician prescribing patterns: findings from the Clinical Outcomes in MEasurement-based Treatment (COMET) trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Using a conversational agent for thought recording as a cognitive therapy task: Feasibility, content, and feedback. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of patient-oriented depression feedback in primary care: The empirical method of the GET.FEEDBACK.GP multicenter randomized controlled trial. [2021]