DepressionNCT04055155
Technology-enabled Task-sharing for Depression in Primary Care
An observational study of Depression and Depression in Old Age, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Depression in Old Age
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Aug 2020
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Show all 20Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Depression in Old Age
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability (system usability scale)
usability of MPATI intervention among provider end-users
Measured: after 2 week usability trial
Usability (qualitative interviews)
usability of MPATI intervention among provider end-users
Measured: after 2 week usability trial
Secondary outcomes (4)
feasibility -- patient recruitment
feasibility of MPATI intervention for geriatric depression in primary care
Measured: end of pilot trial (2 weeks per patient)
acceptability -- patient retention
acceptability of MPATI intervention for geriatric depression in primary care
Measured: end of pilot trial (2 weeks per patient)
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)
Measured: pre-post 2 week pilot trial
functioning (patient)
Sheehan Disability Scale (SDS) total scores to assess functional impairment; total scores range from 0 (unimpaired) to 30 (highly impaired).
Measured: pre-post 2 week pilot trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Sep 2019
- Primary completion1 Jul 2020
- Study completion31 Aug 2020
Why it stopped: Pandemic halt
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Oleg Zaslavsky, University of Washington
- Investigators
- Oleg Zaslavsky, PhD, Principal investigator, University of WashingtonBrenna Renn, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055155
- Sponsor's protocol ID
- STUDY00006748
- Other IDs
- P50MH115837
- Status last verified
- May 2023
- First submitted
- 9 Aug 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering the Capacity of Primary Care Frontline Staff to Deliver a Low-Intensity Technology-Enhanced Intervention to Treat Geriatric Depression
- ClinicalTrials.gov ID
- NCT04055155
- Acronym / sponsor ID
- STUDY00006748
- Conditions
- Depression, Depression in Old Age
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Pandemic halt
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Aug 2019 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability (system usability scale)
Time frame: after 2 week usability trial
usability of MPATI intervention among provider end-users
Usability (qualitative interviews)
Time frame: after 2 week usability trial
usability of MPATI intervention among provider end-users
4 secondary outcomes
feasibility -- patient recruitment
Time frame: end of pilot trial (2 weeks per patient)
acceptability -- patient retention
Time frame: end of pilot trial (2 weeks per patient)
depressive symptoms (patient)
Time frame: pre-post 2 week pilot trial
functioning (patient)
Time frame: pre-post 2 week pilot trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Oleg Zaslavsky, PhD principal investigator
University of Washington
Brenna Renn, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Depression in Old Age, run by University of Washington at 1 site in United States.
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 20 inclusion and 0 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: withdrawn, as of the sponsor's last update on 10 May 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Usability (system usability scale) (time frame: after 2 week usability trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.