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}

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Nova Scotia Health Authority Halifax, Canada

Who Is Running the Clinical Trial?

Nova Scotia Health Authority Lead Sponsor

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] Research shows that feeding back patient-reported outcome information to clinicians and/or patients could be associated with improved care processes and patient outcomes. Quantitative syntheses of intervention effects on oncology patient outcomes are lacking.

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] Inadequate treatments are reported for depressed patients cared for by primary care physicians (PCPs). Providing feedback and evidence-based treatment recommendations for depression to PCPs via electronic medical record improves the quality of interventions.

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] To examine whether feedback and treatment advice for depression presented to primary care physicians (PCPs) via an electronic medical record (EMR) system can potentially improve clinical outcomes and care processes for patients with major depression.

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

Can assessing chronic pain outcomes data improve outcomes? [2019] This manuscript reviews how patient-reported outcomes data can be used to guide efforts to improve patient outcomes.

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] In this secondary analysis from the Clinical Outcomes in MEasurement-based Treatment trial (COMET), we evaluated whether providing primary care physicians with patient-reported feedback regarding depression severity affected pharmacological treatment patterns.

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] Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care.

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

Using a conversational agent for thought recording as a cognitive therapy task: Feasibility, content, and feedback. [2023] E-mental health for depression is increasingly used in clinical practice, but patient adherence suffers as therapist involvement decreases. One reason may be the low responsiveness of existing programs: especially autonomous systems are lacking in their input interpretation and feedback-giving capabilities. Here, we explore (a) to what extent a more socially intelligent and, therefore, technologically advanced solution, namely a conversational agent, is a feasible means of collecting thought record data in dialog, (b) what people write about in their thought records, (c) whether providing content-based feedback increases motivation for thought recording, a core technique of cognitive therapy that helps patients gain an understanding of how their thoughts cause their feelings. Using the crowd-sourcing platform Prolific, 308 participants with subclinical depression symptoms were recruited and split into three conditions of varying feedback richness using the minimization method of randomization. They completed two thought recording sessions with the conversational agent: one practice session with scenarios and one open session using situations from their own lives. All participants were able to complete thought records with the agent such that the thoughts could be interpreted by the machine learning algorithm, rendering the completion of thought records with the agent feasible. Participants chose interpersonal situations nearly three times as often as achievement-related situations in the open chat session. The three most common underlying schemas were the Attachment, Competence, and Global Self-evaluation schemas. No support was found for a motivational effect of providing richer feedback. In addition to our findings, we publish the dataset of thought records for interested researchers and developers.

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] GET.FEEDBACK.GP1 is a multicenter randomized controlled trial testing the efficacy of patient-oriented depression feedback in primary care. This paper describes the complex methods and procedures of the trial. 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 general practitioners receive feedback, and both patients and general practitioners receive feedback. The procedure includes a baseline assessment in primary care practices and three telephone follow-up interviews after one, six, and twelve months. The patients completed a baseline assessment, which determined their depression severity. Those with at least a moderate depression severity (PHQ-95 ≥ 10) were randomly allocated to three groups stratified by depression severity. A standardized mean difference of d = 0.25 with power 1 - β = 0.80 required a total sample size of N = 699. The patients provided responses regarding the primary and secondary outcomes at follow-up. The extensive planning for GET.FEEDBACK.GP involved experts from diverse medical specialties and external corporations. Of particular importance were (a) blinding in the study inclusion and random assignment with data capture software, (b) representative and unbiased patient selection in practice waiting rooms, (c) a data management and safety plan supplied by a specialized trial center, and (d) the use of participant pseudonyms supplied by a specialized service (Mainzelliste). The data collection started in July 2019 and will continue until June 2022. Five university study centers in Germany are participating in the trial.