- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055155
Technology-enabled Task-sharing for Depression in Primary Care
May 8, 2023 updated by: Oleg Zaslavsky, University of Washington
Discovering the Capacity of Primary Care Frontline Staff to Deliver a Low-Intensity Technology-Enhanced Intervention to Treat Geriatric Depression
This study will explore and test the feasibility, acceptability, usability, and preliminary effectiveness of a technology-enabled intervention for depression using task-sharing in primary care.
We will a) discover barriers and facilitators to task-sharing by frontline primary care staff; b) design an implementation strategy to support task-sharing to deliver a technology-enabled intervention for depression; and c) conduct a small open-label usability trial of the technology-enabled intervention for depression.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Older adults with depression typically present to primary care rather than specialty mental health treatment and are often un- or undertreated, as the demand for mental health services is greater than the supply of trained providers.
Technology is one method to improve access to care by making evidence-based psychosocial interventions (EBPIs) readily accessible.
A second method comes from global mental health research, demonstrating that task-sharing can equip non-specialists to provide effective mental health care.
This study combines these two approaches, exploring how technology-enhanced EBPI could be used by frontline primary care staff (e.g., nurses, medical assistants) to expand workforce capacity to deliver acceptable, sustainable, and effective treatment for depression.
Specifically, we will use task-sharing to deliver a mobile Motivational Physical Activity Targeted Intervention (MPATI), which is based on behavioral activation for depression and uses wearable accelerometer technology to trigger personalized activity goal monitoring.
This proposal uses the Discover, Design/Build, Test (DDBT) framework, which leverages user-centered design and implementation science to discover implementation barriers to using task-sharing to deliver MPATI in primary care, to design an implementation strategy to support MPATI delivery, and to conduct a pilot usability trial to test the implementation strategy with the most suitable frontline staff.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- Univeristy of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Primary care clinics: administrators, primary care providers, behavioral health providers, frontline primary care staff (e.g., nurses, medical assistants)
Patients: older adult primary care patients with mild-to-moderate depressive symptoms
Description
Inclusion Criteria:
Clinics:
- have at least 1 full-time registered nurse (RN) and/or medical assistant (MA) on staff
- include older adults on their patient panels.
Clinic administrators
- have an administrative or leadership role in the clinic
- have been employed in their current role for at least 6 months.
Frontline staff
- provide care as RN, MA, case manager, behavioral health consultant, or similar role identified by Practice Champion
- be employed at the participating clinic for at least 6 months.
Patients
- be ≥65 years of age
- report moderate to moderately severe depressive symptoms based on a PHQ-9 score of 10-20
- own or have access to a smartphone
- have internet or cellular data plan
- receive medical clearance from their primary care provider to participate in unstructured physical activity.
Patient exclusion criteria will be based on medical chart review by Practice Champion and include:
- current suicidality
- severe vision or hearing impairment
- pronounced cognitive impairment
- use of assistive devices that would impede physical activity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Staff/Provider end-users
Testing usability of a technology-enabled behavioral intervention for depression among provider end-users in primary care.
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Patient participants
Testing acceptability, feasibility, and preliminary effectiveness of a technology-enabled behavioral intervention for depression among patients with depression in primary care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability (system usability scale)
Time Frame: after 2 week usability trial
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usability of MPATI intervention among provider end-users
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after 2 week usability trial
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Usability (qualitative interviews)
Time Frame: after 2 week usability trial
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usability of MPATI intervention among provider end-users
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after 2 week usability trial
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feasibility -- patient recruitment
Time Frame: end of pilot trial (2 weeks per patient)
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feasibility of MPATI intervention for geriatric depression in primary care
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end of pilot trial (2 weeks per patient)
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acceptability -- patient retention
Time Frame: end of pilot trial (2 weeks per patient)
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acceptability of MPATI intervention for geriatric depression in primary care
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end of pilot trial (2 weeks per patient)
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depressive symptoms (patient)
Time Frame: pre-post 2 week pilot trial
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Patient Health Questionnaire (PHQ-9) total scores to assess depressive symptoms (total score range 0-27; higher scores reflect greater depressive symptoms)
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pre-post 2 week pilot trial
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functioning (patient)
Time Frame: pre-post 2 week pilot trial
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Sheehan Disability Scale (SDS) total scores to assess functional impairment; total scores range from 0 (unimpaired) to 30 (highly impaired).
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pre-post 2 week pilot trial
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
user burden
Time Frame: end of 2 week pilot trial
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user burden of technology-enabled intervention for patients and providers
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end of 2 week pilot trial
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Oleg Zaslavsky, PhD, University of Washington
- Principal Investigator: Brenna Renn, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
August 9, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006748
- P50MH115837 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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