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Telehealth Depression Treatments for Older Adults

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ClinicalTrials.gov Identifier: NCT02600754
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
University of Kansas Medical Center
Information provided by (Responsible Party):
Namkee Choi, University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: IT-PST Behavioral: IT-SCM Not Applicable

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.)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telehealth Treatments for Depression With Low-Income Homebound Seniors
Actual Study Start Date : February 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IT-PST
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
5 sessions of problem-solving therapy by licensed mental health clinicians co-located in an aging-service agency (Meals on Wheels and More)

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

No Intervention: Wait-list control (Usual Care or UC)
Participants who will serve as controls with telephone safety calls



Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression [ Time Frame: 36 weeks ]
    24-item depression scale


Secondary Outcome Measures :
  1. World Health Organization Disability Assessment Schedule [ Time Frame: 36 weeks ]
    12-item disability assessment

  2. Euro-Quol [ Time Frame: 36 weeks ]
    measure of depression free days

  3. Cornell Service Index [ Time Frame: 36 week ]
    measure of physical and mental health, and social service use



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600754


Contacts
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Contact: Namkee G Choi, PhD 512-232-9590 nchoi@austin.utexas.edu
Contact: Jessica E Lim, MSSW 512-232-0604 jessica.lim@austin.utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712-0358
Contact: Namkee G. Choi, PhD    512-232-9590    nchoi@mail.utexas.edu   
Principal Investigator: Namkee G. Choi, PhD         
Sponsors and Collaborators
University of Texas at Austin
Baylor College of Medicine
University of Kansas Medical Center
Investigators
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Principal Investigator: Namkee G Choi, PhD University of Texas at Austin

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Responsible Party: Namkee Choi, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02600754     History of Changes
Other Study ID Numbers: 1R01MD009675 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Namkee Choi, University of Texas at Austin:
older adults, depressive symptoms, psychosocial treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders