NCT03762460

Brief Summary

This feasibility study investigates the use of eHealth tools within routine medical treatment for patients with depression in an outpatient psychiatric setting. The study investigates whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible, and whether clinical and functional outcomes improve with use of the online eHealth tool, compared to informational online resources for mental health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2.6 years

First QC Date

April 11, 2018

Last Update Submit

August 2, 2023

Conditions

Depression

Keywords

Measurement-Based Caree-Mental HealthFunctional OutcomesOccupational FunctioningCognitionMobile Technology

Outcome Measures

Primary Outcomes (1)

  • Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period

    Percentage of patients who use the eHealth tool (MoodFx), defined as 3 or more uses over the 6-month follow up period

    6 months

Secondary Outcomes (8)

  • Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months.

    8 weeks and 6 months

  • Change scores on the Patient Health Questionnaire (PHQ-9) from baseline to follow up at 8 weeks and 6 months.

    8 weeks and 6 months

  • Change scores on the Generalized Anxiety Disorder scale (GAD-7) from baseline to follow up at 8 weeks and 6 months.

    8 weeks and 6 months

  • Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.

    8 weeks and 6 months

  • Change scores on the Lam Employment Absence and Productivity Scale (LEAPS) from baseline to follow up at 8 weeks and 6 months.

    8 weeks and 6 months

  • +3 more secondary outcomes

Study Arms (2)

Online eHealth Tool

EXPERIMENTAL

Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool.

Other: Online eHealth tool

Informational website (control)

PLACEBO COMPARATOR

Participants randomized to this group will receive information about online resources for mental health

Other: Informational website

Interventions

Online eHealth toolOTHER

Mobile-optimized online eHealth tool to support MBC.

Online eHealth Tool
Informational websiteOTHER

Participants randomized to this group will receive information about online resources for mental health

Informational website (control)

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 19-65 and capable of informed consent;
  • diagnosis of major depressive episode (MDE) by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist;
  • at least moderate depression as defined by QIDS-SR score of 10 or higher on the Quick Inventory for Depressive Symptomatology, Self-Rated (QIDS-SR);
  • access to an Internet-enabled computer or mobile device; and
  • able to read and understand English sufficiently to use the eMBC platform

You may not qualify if:

  • active psychotic or substance use disorder; or
  • severe suicidality as judged by the psychiatrist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Mood Disorders Centre

Vancouver, British Columbia, V6T1Z3, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Raymond W Lam, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2018

First Posted

December 3, 2018

Study Start

April 1, 2020

Primary Completion

November 9, 2022

Study Completion

December 31, 2022

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)