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Telehealth Depression Treatments for Older Adults

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IT-PST
IT-SCM
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring older adults, depressive symptoms, psychosocial treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

IT-PST

IT-SCM

Wait-list control (Usual Care or UC)

Arm Description

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).

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).

Participants who will serve as controls with telephone safety calls

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression
24-item depression scale

Secondary Outcome Measures

World Health Organization Disability Assessment Schedule
12-item disability assessment
Euro-Quol
measure of depression free days
Cornell Service Index
measure of physical and mental health, and social service use

Full Information

First Posted
November 6, 2015
Last Updated
April 26, 2021
Sponsor
University of Texas at Austin
Collaborators
Baylor College of Medicine, University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02600754
Brief Title
Telehealth Depression Treatments for Older Adults
Official Title
Telehealth Treatments for Depression With Low-Income Homebound Seniors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Baylor College of Medicine, University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The long-term objective of the proposed study is to improve access to depression treatments for low-income, racially diverse homebound seniors, a population experiencing significant disparities in mental health care due to their homebound and low-income status. Specific aims are to compare the acceptability, clinical effectiveness, treatment cost, and budget impact of the two teledelivered treatment delivery models: problem-solving therapy (PST) by licensed clinicians and self-care management (SCM) support by trained lay mental health workers/advisors. The interventionists will be integrated into an aging-service agency; hence, integrated tele-PST (IT-PST) ad integrated tele-SCM (IT-SCM). Although tele-psychotherapy is likely to be an effective mental health service delivery model for the target population, the current and projected shortage of such clinicians and the costs of deploying highly trained professionals pose barriers to this model's widespread real-world adoption and sustainability. A more plausible option may indeed have to utilize trained lay mental health workers. The study participants will be 276 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Austin, Tex. In a 3-arm, pragmatic clinical trial with randomization prior to consent (a preferred public health approach), the participants will receive five sessions of IT-PST, five sessions of IT-SCM, or five telephone check-in calls (for the usual care-UC-group). Our first hypothesis is that IT-PST and IT-SCM will be equally acceptable to the participants. Our second hypothesis is that both IT-PST and IT-SCM will be more effective than UC in reducing depressive symptoms, although IT-PST may be more effective than IT-SCM. Symptoms will be assessed with the 24-item Hamilton Depression Rating Scale (HAMD) at 12, 24, and 36 weeks after baseline. Additional outcomes will be depression-free days (DFDs) and disability (WHODAS 2.0). Our third hypothesis is that IT-SCM will have a lower delivery cost than IT-PST, but both IT-PST and IT-SCM will be more cost-effective than usual care. The analyses include (a) comparisons of delivery costs between IT-PST and IT-SCM; (b) assessment of cost-effectiveness (CEA) based on DFDs and health-related quality adjusted life-year measured by EuroQol-5 (EQ-5D); and (3) budget impact (BIA) of IT-PST relative to IT-SCM. Both CEA and BIA will employ a hybrid public program perspective of the AoA and the Centers for Medicare and Medicaid. Public health significance of this study is that the data will help aging-service providers and funders assess respective strengths and weaknesses of each model as a sustainable approach to providing depression care for an underserved and growing population group and improving their access to evidence-based mental health services. (The terms older adults and seniors are used interchangeably because the latter term is frequently used in aging services.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
older adults, depressive symptoms, psychosocial treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IT-PST
Arm Type
Experimental
Arm Description
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).
Arm Title
IT-SCM
Arm Type
Experimental
Arm Description
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).
Arm Title
Wait-list control (Usual Care or UC)
Arm Type
No Intervention
Arm Description
Participants who will serve as controls with telephone safety calls
Intervention Type
Behavioral
Intervention Name(s)
IT-PST
Intervention Description
5 sessions of problem-solving therapy by licensed mental health clinicians co-located in an aging-service agency (Meals on Wheels and More)
Intervention Type
Behavioral
Intervention Name(s)
IT-SCM
Intervention Description
5 sessions of self-care management support by trained lay advisers co-located in an aging-service agency (Meals on Wheels and More)
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Description
24-item depression scale
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
World Health Organization Disability Assessment Schedule
Description
12-item disability assessment
Time Frame
36 weeks
Title
Euro-Quol
Description
measure of depression free days
Time Frame
36 weeks
Title
Cornell Service Index
Description
measure of physical and mental health, and social service use
Time Frame
36 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) HAMD >14; (2) age > 49; (3) English or Spanish Speaking; and (4) Non-Hispanic White, Black, or Hispanic Exclusion Criteria: (1) antidepressant intake < 9 weeks; (2) high suicide risk; (3) probable dementia;( 4) bipolar disorder; and (5) substance use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namkee G Choi, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712-0358
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36253766
Citation
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.
Results Reference
derived
PubMed Identifier
32865577
Citation
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.
Results Reference
derived

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Telehealth Depression Treatments for Older Adults

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