Technology-enabled Task-sharing for Depression in Primary Care

Withdrawn

• Conditions: Depression in Old Age; Depression

• Registration Number: NCT04055155
• Lead Sponsor: University of Washington

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Study Start: 2019-09-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-08-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Clinics:

1. have at least 1 full-time registered nurse (RN) and/or medical assistant (MA) on staff
2. include older adults on their patient panels.

Clinic administrators

1. have an administrative or leadership role in the clinic
2. have been employed in their current role for at least 6 months.

Frontline staff

1. provide care as RN, MA, case manager, behavioral health consultant, or similar role identified by Practice Champion
2. be employed at the participating clinic for at least 6 months.

Patients

1. be ≥65 years of age
2. report moderate to moderately severe depressive symptoms based on a PHQ-9 score of 10-20
3. own or have access to a smartphone
4. have internet or cellular data plan
5. 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:

1. current suicidality
2. severe vision or hearing impairment
3. pronounced cognitive impairment
4. use of assistive devices that would impede physical activity.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usability (system usability scale)	after 2 week usability trial	usability of MPATI intervention among provider end-users
Usability (qualitative interviews)	after 2 week usability trial	usability of MPATI intervention among provider end-users

Secondary Outcome Measures

Name	Time	Method
acceptability -- patient retention	end of pilot trial (2 weeks per patient)	acceptability of MPATI intervention for geriatric depression in primary care
depressive symptoms (patient)	pre-post 2 week pilot trial	Patient Health Questionnaire (PHQ-9) total scores to assess depressive symptoms (total score range 0-27; higher scores reflect greater depressive symptoms)
feasibility -- patient recruitment	end of pilot trial (2 weeks per patient)	feasibility of MPATI intervention for geriatric depression in primary care
functioning (patient)	pre-post 2 week pilot trial	Sheehan Disability Scale (SDS) total scores to assess functional impairment; total scores range from 0 (unimpaired) to 30 (highly impaired).

Trial Locations

Locations (1)

Univeristy of Washington; 🇺🇸 Seattle, Washington, United States