NCT02600754

Brief Summary

This study aims to find an effective and sustainable approach to reducing disparities in accessing mental health services for an underserved and growing population group of low-income, racially diverse, homebound older adults. It will compare two aging-service integrated, teledelivered depression treatments for these seniors. One model is short-term problem-solving therapy by licensed clinicians; the second model is self-care management support by trained lay advisors. The findings are expected to create a foundation of information for guiding the implementation of acceptable, effective, and sustainable depression care within widely available aging-service infrastructures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4.8 years

First QC Date

November 6, 2015

Last Update Submit

April 26, 2021

Conditions

Depression

Keywords

older adults, depressive symptoms, psychosocial treatment

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression

    24-item depression scale

    36 weeks

Secondary Outcomes (3)

  • World Health Organization Disability Assessment Schedule

    36 weeks

  • Euro-Quol

    36 weeks

  • Cornell Service Index

    36 week

Study Arms (3)

IT-PST

EXPERIMENTAL

IT-PST refers to problem-solving therapy that will be tele-delivered by licensed mental health clinicians co-located in an aging-service agency (Meals on Wheels and More).

Behavioral: IT-PST

IT-SCM

EXPERIMENTAL

IT-SCM refers to self-care management support that will be tele-delivered by trained lay advisers (TLAs) co-located in an aging-service agency (Meals on Wheels and More).

Behavioral: IT-SCM

Wait-list control (Usual Care or UC)

NO INTERVENTION

Participants who will serve as controls with telephone safety calls

Interventions

IT-PSTBEHAVIORAL

5 sessions of problem-solving therapy by licensed mental health clinicians co-located in an aging-service agency (Meals on Wheels and More)

IT-PST
IT-SCMBEHAVIORAL

5 sessions of self-care management support by trained lay advisers co-located in an aging-service agency (Meals on Wheels and More)

IT-SCM

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) HAMD \>14; (2) age \> 49; (3) English or Spanish Speaking; and (4) Non-Hispanic White, Black, or Hispanic

You may not qualify if:

  • (1) antidepressant intake \< 9 weeks; (2) high suicide risk; (3) probable dementia;( 4) bipolar disorder; and (5) substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712-0358, United States

Location

Related Publications (2)

  • Chen GJ, Kunik ME, Marti CN, Choi NG. Cost-effectiveness of Tele-delivered behavioral activation by Lay counselors for homebound older adults with depression. BMC Psychiatry. 2022 Oct 17;22(1):648. doi: 10.1186/s12888-022-04272-9.

    PMID: 36253766DERIVED

  • Choi NG, Marti CN, Wilson NL, Chen GJ, Sirrianni L, Hegel MT, Bruce ML, Kunik ME. Effect of Telehealth Treatment by Lay Counselors vs by Clinicians on Depressive Symptoms Among Older Adults Who Are Homebound: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2015648. doi: 10.1001/jamanetworkopen.2020.15648.

    PMID: 32865577DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Namkee G Choi, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 9, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

US(1)