Technology-enabled Task-sharing for Depression in Primary Care

Sponsor
University of Washington (Other)
Overall Status
Unknown status
CT.gov ID
NCT04055155
Collaborator
National Institute of Mental Health (NIMH) (NIH)
12
1
12
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Discovering the Capacity of Primary Care Frontline Staff to Deliver a Low-Intensity Technology-Enhanced Intervention to Treat Geriatric Depression
    Anticipated Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Aug 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Staff/Provider end-users

    Testing usability of a technology-enabled behavioral intervention for depression among provider end-users in primary care.

    Patient participants

    Testing acceptability, feasibility, and preliminary effectiveness of a technology-enabled behavioral intervention for depression among patients with depression in primary care.

    Outcome Measures

    Primary Outcome Measures

    1. Usability (system usability scale) [after 2 week usability trial]

      usability of MPATI intervention among provider end-users

    2. Usability (qualitative interviews) [after 2 week usability trial]

      usability of MPATI intervention among provider end-users

    Secondary Outcome Measures

    1. feasibility -- patient recruitment [end of pilot trial (2 weeks per patient)]

      feasibility of MPATI intervention for geriatric depression in primary care

    2. acceptability -- patient retention [end of pilot trial (2 weeks per patient)]

      acceptability of MPATI intervention for geriatric depression in primary care

    3. 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)

    4. 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).

    Other Outcome Measures

    1. user burden [end of 2 week pilot trial]

      user burden of technology-enabled intervention for patients and providers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univeristy of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • University of Washington
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Oleg Zaslavsky, PhD, University of Washington
    • Principal Investigator: Brenna Renn, PhD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oleg Zaslavsky, Assistant Professor, Biobehavioral Nursing and Health Systems, University of Washington
    ClinicalTrials.gov Identifier:
    NCT04055155
    Other Study ID Numbers:
    • STUDY00006748
    • P50MH115837
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2019