Technology-enabled Task-sharing for Depression in Primary Care

Depression Clinical Trial

Official title:

Discovering the Capacity of Primary Care Frontline Staff to Deliver a Low-Intensity Technology-Enhanced Intervention to Treat Geriatric Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04055155
• Other study ID #: STUDY00006748
• Secondary ID: P50MH115837
• Status: Withdrawn
• Start date: September 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression in Old Age
• Depressive Disorder

Locations

Country	Name	City	State
United States	Univeristy of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	user burden	user burden of technology-enabled intervention for patients and providers	end of 2 week pilot trial
Primary	Usability (system usability scale)	usability of MPATI intervention among provider end-users	after 2 week usability trial
Primary	Usability (qualitative interviews)	usability of MPATI intervention among provider end-users	after 2 week usability trial
Secondary	feasibility -- patient recruitment	feasibility of MPATI intervention for geriatric depression in primary care	end of pilot trial (2 weeks per patient)
Secondary	acceptability -- patient retention	acceptability of MPATI intervention for geriatric depression in primary care	end of pilot trial (2 weeks per patient)
Secondary	depressive symptoms (patient)	Patient Health Questionnaire (PHQ-9) total scores to assess depressive symptoms (total score range 0-27; higher scores reflect greater depressive symptoms)	pre-post 2 week pilot trial
Secondary	functioning (patient)	Sheehan Disability Scale (SDS) total scores to assess functional impairment; total scores range from 0 (unimpaired) to 30 (highly impaired).	pre-post 2 week pilot trial