Feedback to Improve Depression Outcomes

NCT03162211 | Recruiting

• 2 other identifiers: 1022385Catalyst 1160
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Meaningful change in treatment

  The first primary outcome will be a meaningful change in treatment as assessed by a clinical expert using CANMAT guidelines.

  Month 0-6

• Total score QIDS-SR

  The second primary outcome will be the total score ranging from 0-27 on the 16-item QIDS-SR, a widely used and extensively validated self-report measure of depressive symptoms that aligns closely with DSM diagnostic criteria for depression.

  Month 0-6

Secondary Outcomes (5)

• Montgomery Asberg Depression Rating Scale (MADRS)

  Month 0-6

• WSAS

  Month 0-6

• LEAPS

  Month 0-6

• EQ-5D

  Month 0-6

• My Top Goal

  Month 0-6

Study Arms (2)

Feedback Arm

EXPERIMENTAL

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.

Other: Feedback Report

No Feedback Arm

NO 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.

Interventions

Feedback Report OTHER

There are two types of feedback forms: 1. Patient feedback forms and 2. Clinician feedback forms. Feedback form content has been developed in consultation with a board of clinicians, service providers, and patients living with depression. 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.

Feedback Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5)
• depression being the primary current problem requiring clinical attention judged by an intake clinician
• age 18 or more (no upper limit)
• capacity to provide informed consent

You may not qualify if:

• lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, current alcohol or drug use disorder
• pregnancy
• acute suicide risk (Montgomery and Asberg Depression Rating Scales (MADRS) (suicide item≥4)
• current psychotic symptoms.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Rudolf Uher, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudolf Uher, MD, PhD

CONTACT

1-902-473-7209; rudolf.uher@nshealth.ca

Jill Cumby, RN

CONTACT

1-902-473-1782; jill.cumbyl@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 22, 2017
• Study Start: September 10, 2017
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)