Feedback Reports for Depression

(PCMBC Trial)

Overseen By Jill Cumby, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help people with depression improve their well-being. It tests whether personalized feedback (Feedback Report) for both patients and clinicians enhances treatment outcomes. Participants are divided into two groups—one receives regular feedback based on questionnaire responses, while the other does not. The trial seeks adults diagnosed with depression who consider it their main issue affecting daily life. The goal is to determine if this feedback system can make depression treatment more effective and affordable.

As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance depression treatment strategies.

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 prior data suggests that this feedback report is safe for patients with depression?

Research shows that providing feedback to patients and their doctors is generally safe and doesn't cause significant side effects. Studies have found that feedback is well-tolerated. For example, when patients and doctors receive specific feedback after depression screening, it doesn't significantly alter depression severity compared to regular care without feedback. This indicates a small, low-risk approach.

Overall, using feedback as a treatment tool is considered safe and can be a helpful addition to regular care without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Feedback Reports for Depression because this approach provides an innovative way to enhance treatment engagement and personalize care. Unlike traditional treatments that rely solely on medication or therapy sessions, this method leverages technology to deliver regular, personalized feedback to both patients and clinicians. The feedback forms offer a visual representation of the patient's depression severity and progress towards treatment goals, encouraging active participation and informed discussions during monthly clinician meetings. This tailored feedback system has the potential to empower patients and improve treatment outcomes by fostering a collaborative approach to mental health care.

What evidence suggests that personalized feedback reports could be effective for depression?

Research has shown that giving feedback to patients and their doctors can help improve depression. In this trial, participants in the Feedback Arm will receive personalized feedback reports, which studies have shown can lead to better results for people with depression. One study demonstrated that personalized feedback, based on patient reports, improved mental health. However, some studies suggest that feedback alone might not always reduce depression symptoms. Participants in the No Feedback Arm will not receive regular feedback reports. Combining feedback with other treatment methods may provide more consistent benefits. Overall, feedback can be a helpful tool, but its effectiveness may vary. ^{1 3 6 7 8}

Who Is on the Research Team?

Rudolf Uher, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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.

depression being the primary current problem requiring clinical attention judged by an intake clinician

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.).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Feedback Report

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Providing electronic feedback about a patient's depression diagnosis to primary care physicians (PCPs) led to a quick response, with a median time of just 1 day for PCPs to acknowledge the diagnosis, which positively influenced their management decisions.

When PCPs agreed with the depression diagnosis sooner, they were significantly more likely to document the diagnosis, start antidepressant therapy, or refer patients to mental health specialists, highlighting the importance of timely communication in improving treatment outcomes.

NCBI (Pubmed)

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]. Rollman, BL., Hanusa, BH., Gilbert, T., et al.[2019]

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]

The GET.FEEDBACK.GP trial is a multicenter randomized controlled study involving 699 patients to evaluate the impact of patient-oriented depression feedback in primary care, with a focus on depression severity measured six months after feedback.

The trial employs rigorous methods including blinding, unbiased patient selection, and a comprehensive data management plan, ensuring the reliability of results as it continues until June 2022 across five university centers in Germany.

NCBI (Pubmed)

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. Lehmann, M., Kohlmann, S., Braunschneider, LE., et al.[2021]

The GET.FEEDBACK.GP RCT aims to evaluate the effectiveness of tailored feedback interventions for patients who screen positive for depression in primary care, involving 1074 participants over 12 months.

This study is significant as it is the first multicenter trial to assess the impact of patient-targeted feedback on depression severity and patient engagement in mental healthcare, potentially influencing future depression treatment guidelines.

NCBI (Pubmed)

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. Kohlmann, S., Lehmann, M., Eisele, M., et al.[2021]

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]

Integrating patient-reported outcomes data into the management of chronic, non-cancer pain can significantly guide improvements in patient care and outcomes.

Standardizing care processes and using valid outcome measurement tools can enhance the effectiveness of treatment while minimizing the burden on patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can assessing chronic pain outcomes data improve outcomes? Witkin, LR., Farrar, JT., Ashburn, MA.[2019]

A randomized controlled trial involving 200 primary care patients with major depression found that providing electronic feedback and treatment advice to physicians did not significantly improve patient recovery rates or clinical outcomes after 3 and 6 months.

Despite a decrease in average depression scores among all patients, only 22% recovered fully by the 6-month mark, and care processes remained similar across different levels of EMR feedback, indicating that simply informing physicians electronically may not enhance the quality of depression care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial using computerized decision support to improve treatment of major depression in primary care. Rollman, BL., Hanusa, BH., Lowe, HJ., et al.[2022]

In a study involving 915 patients with major depressive disorder, providing primary care physicians with monthly feedback on patient-reported depression severity did not significantly change their antidepressant treatment patterns over a 6-month period.

Only a small percentage of patients adjusted their antidepressant regimen, with minimal changes observed among those who were partial or nonresponders, indicating a lack of active management in treating depression in primary care settings.

NCBI (Pubmed)

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. Chang, TE., Jing, Y., Yeung, AS., et al.[2019]

Citations

1.

thelancet.com

thelancet.com/journals/lanpsy/article/PIIS2215-0366(24)00035-X/fulltext

Clinical effectiveness of patient-targeted feedback ...

Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714421002986

Clinical effectiveness of patient-oriented depression ...

The primary outcome is depression severity six months after feedback, and we vary who is the target of the feedback as follows: no one receives feedback, only ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4516646/

The Effectiveness of Clinician Feedback in the Treatment ...

Our results indicate that the CCFS is effective in improving outcomes for patients in outpatient treatment for depression in the community mental health setting ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38432236/

Clinical effectiveness of patient-targeted feedback ...

Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178122004723

Effect of brief, personalized feedback derived from ...

This study aimed to determine the efficacy of digitalized personalized feedback derived from experience sampling method (ESM) data for improving women's mental ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7507856/

Depression screening using patient-targeted feedback in ...

We assume that the patient-targeted feedback intervention will have a significant but small effect on depression severity 6 months after ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11703940/

Using Progress Feedback to Enhance Treatment Outcomes

We conclude that while feedback has modest effects, it is a small and affordable intervention that can potentially improve outcomes in psychological ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589750024000700

The efficacy of automated feedback after internet-based ...

The results of our trial indicated that automated feedback following internet-based depression screening did not reduce depression severity 6 months after ...