DepressionNCT03762460
A Pilot Study of eHealth Tools in a Tertiary-care Setting
A study testing Online eHealth tool and Informational website in people with Depression, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Online eHealth tool and Informational website
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active psychotic or substance use disorder; or
- severe suicidality as judged by the psychiatrist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Clinical Trial of eHealth Tools
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.
Read the detailed description
Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric disorder and as one of the most common medical diagnoses worldwide.
Measurement-based care (MBC) is an evidence-based approach for providing effective clinical care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity, functional impairments, treatment adherence, and side-effect burden to personalize clinical decision-making based on measured outcomes and clinical algorithms. However, despite evidence demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to the use of MBC include lack of knowledge of which scales to use, how to incorporate measurements into clinical charting systems, and the extra time needed for repeated assessments.
Our research team developed a web-based application (app) optimized for mobile devices to address the treatment gap in MBC for people with depression, especially those who are working while depressed. This user-friendly eHealth tool encourages patients to actively participate in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage depressive symptoms and functional outcomes. Results can be easily displayed and printed to share with clinicians, thereby affording health professionals a simple and cost-effective means to integrate MBC into standard practices and to optimize treatment for MDD at the point of care, without needing additional materials, equipment, or staffing.
This research study investigates the feasibility of using a mobile-optimized online eHealth tool to support MBC in routine clinical care for MDD within an outpatient psychiatric setting.
To determine both the clinical and practical utility of eMBC, this study will enroll "real-world" patients with few exclusion criteria and undergoing naturalistic treatments so that findings will be generalizable to other clinical settings and practices.
Note: As of April, 2020 (before recruitment started), because of the pandemic the study protocol was changed to be fully virtual, with a change in the primary outcome to a patient feasibility outcome.
- Conditions
- Depression
- Being tested
- Online eHealth tool, Informational website
- Keywords
- Measurement-Based Care, e-Mental Health, Functional Outcomes, Occupational Functioning, Cognition, Mobile Technology
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online eHealth toolOther
Mobile-optimized online eHealth tool to support MBC.
Informational websiteOther
Participants randomized to this group will receive information about online resources for mental health
| Study group | Role | What they receive |
|---|---|---|
| Online eHealth Tool | Experimental | Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool. Receives: Other: Online eHealth tool |
| Informational website (control) | Placebo comparator | Participants randomized to this group will receive information about online resources for mental health Receives: Other: Informational website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a self-report scale to assess symptoms of depression and consists of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted towards the total score). Higher scores indicate more severe symptoms, with individual item scores ranging from 0-3 and total scores ranging from 0-27.
Measured: 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.
The Patient Health Questionnaire (PHQ-9) is a brief, self-rated scale assessing symptoms of depression. The scale consists of 9 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-27.
Measured: 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.
The Generalized Anxiety Disorder scale (GAD-7) is a brief, self-rated scale assessing symptoms of generalized anxiety. The scale consists of 7 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-21.
Measured: 8 weeks and 6 months
Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.
The Sheehan Disability Scale (SDS) is a brief self-report scale assessing functional impairment in three inter-related domains: work/school, social and home/family life. The user rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 11 point visual analog scale (range 0-10). Higher scores indicate greater impairment.
Measured: 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.
The Lam Employment Absence and Productivity Scale (LEAPS) is a brief self-rated scale to assess patients' work functioning. The LEAPS consists of 10 items rated on a 5-point scale from 0-4, with higher scores indicating greater impairment. Item scores are summed to yield a total score, range 0-28.
Measured: 8 weeks and 6 months
Change scores on the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to follow up at 8 weeks and 6 months.
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire assessing life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score.
Measured: 8 weeks and 6 months
Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months.
The Euro-QOL scale (EQ-5D) is a standardised self-report instrument for measuring generic health status. It consists of 5 items evaluating rated on a 5-level scale from no impairments to complete impairment. The 5 rating levels can be quantified as ranging from 0 to 4, with higher scores indicating higher impairment. Total score ranges from 0 to 20.
Measured: 8 weeks and 6 months
Satisfaction with eHealth tool as measured by the System Usability Scale.
The System Usability Scale is a 10-item survey that evaluates user satisfaction with online tools, applications, etc. Each item is rated on a 5-point scale (from 0-4), with higher scores indicating greater satisfaction. Item scores may be added together to yield scores ranging from 0-40, and then multiplied by 2.5 for scores ranging from 0-100. (Note these scores are not percentages or percentiles.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Apr 2020
- Primary completion9 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, Healthy Minds Canada, Pfizer
- Responsible party
- Principal investigator, Raymond Lam, University of British Columbia
- Investigators
- Raymond W Lam, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762460
- Sponsor's protocol ID
- H17-02786
- Other IDs
- V17-02786
- Status last verified
- Aug 2023
- First submitted
- 11 Apr 2018
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li VW, Sahota J, Dev DK, Gill DD, Evans VC, Axler A, Chakrabarty T, Do A, Keramatian K, Nunez JJ, Tam EM, Yatham LN, Michalak EE, Murphy JK, Lam RW. A Randomized Evaluation of MoodFX, a Patient-Centred e-Health Tool to Support Outcome Measurement for Depression: Une evaluation randomisee de MoodFX, un outil de sante en ligne centre sur le patient pour soutenir la mesure du resultat dans la depression. Can J Psychiatry. 2024 Jul;69(7):493-502. doi: 10.1177/07067437241245331. Epub 2024 Apr 11.
PubMed 38600892
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Clinical Trial of eHealth Tools
- ClinicalTrials.gov ID
- NCT03762460
- Acronym / sponsor ID
- H17-02786
- Conditions
- Depression
- Keywords
- Measurement-Based Care, e-Mental Health, Functional Outcomes, Occupational Functioning, Cognition, Mobile Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, Healthy Minds Canada, Pfizer
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric disorder and as one of the most common medical diagnoses worldwide.
Measurement-based care (MBC) is an evidence-based approach for providing effective clinical care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity, functional impairments, treatment adherence, and side-effect burden to personalize clinical decision-making based on measured outcomes and clinical algorithms. However, despite evidence demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to the use of MBC include lack of knowledge of which scales to use, how to incorporate measurements into clinical charting systems, and the extra time needed for repeated assessments.
Our research team developed a web-based application (app) optimized for mobile devices to address the treatment gap in MBC for people with depression, especially those who are working while depressed. This user-friendly eHealth tool encourages patients to actively participate in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage depressive symptoms and functional outcomes. Results can be easily displayed and printed to share with clinicians, thereby affording health professionals a simple and cost-effective means to integrate MBC into standard practices and to optimize treatment for MDD at the point of care, without needing additional materials, equipment, or staffing.
This research study investigates the feasibility of using a mobile-optimized online eHealth tool to support MBC in routine clinical care for MDD within an outpatient psychiatric setting.
To determine both the clinical and practical utility of eMBC, this study will enroll "real-world" patients with few exclusion criteria and undergoing naturalistic treatments so that findings will be generalizable to other clinical settings and practices.
Note: As of April, 2020 (before recruitment started), because of the pandemic the study protocol was changed to be fully virtual, with a change in the primary outcome to a patient feasibility outcome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online eHealth Tool | Experimental | Other: Online eHealth toolParticipants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool. |
| Informational website (control) | Placebo comparator | Other: Informational websiteParticipants randomized to this group will receive information about online resources for mental health |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- active psychotic or substance use disorder; or
- severe suicidality as judged by the psychiatrist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online eHealth toolMobile-optimized online eHealth tool to support MBC. | Other | Online eHealth Tool |
| Informational websiteParticipants randomized to this group will receive information about online resources for mental health | Other | Informational website (control) |
Primary outcome
Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period
Time frame: 6 months
Percentage of patients who use the eHealth tool (MoodFx), defined as 3 or more uses over the 6-month follow up period
8 secondary outcomes
Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks and 6 months
Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.
Time frame: 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.
Time frame: 8 weeks and 6 months
Change scores on the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to follow up at 8 weeks and 6 months.
Time frame: 8 weeks and 6 months
Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months.
Time frame: 8 weeks and 6 months
Satisfaction with eHealth tool as measured by the System Usability Scale.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 38600892Li VW, Sahota J, Dev DK, Gill DD, Evans VC, Axler A, Chakrabarty T, Do A, Keramatian K, Nunez JJ, Tam EM, Yatham LN, Michalak EE, Murphy JK, Lam RW. A Randomized Evaluation of MoodFX, a Patient-Centred e-Health Tool to Support Outcome Measurement for Depression: Une evaluation randomisee de MoodFX, un outil de sante en ligne centre sur le patient pour soutenir la mesure du resultat dans la depression. Can J Psychiatry. 2024 Jul;69(7):493-502. doi: 10.1177/07067437241245331. Epub 2024 Apr 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond W Lam, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online eHealth tool and Informational website in people with Depression, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.