Depression Clinical Trial
Official title:
Happy@Home: Delivering Internet-based Cognitive Behavioral Therapy With Homecare Workers to At-Home Seniors
Depression is one of the most common and debilitating conditions among older adults. At-home seniors, also called homebound seniors, are older adults who are confined to a bed or chair and are unable to get about outdoors. Internet-based CBT (iCBT) delivers CBT via websites or dedicated apps on mobile devices or tablets. iCBT can be self-administered or guided by a therapist. Its strengths include low-cost, accessibility, and ability to tailor to individual needs while maintaining fidelity. Despite its potential, iCBT trials have rarely included older adults. Those that included older adults showed that they tended to report more technological challenges but they benefited from the intervention as much as younger adults did. As far as we know, studies have not yet tested the feasibility and preliminary effects of iCBT with a diverse group of at-home seniors receiving non-skilled home care. This study explores the feasibility and acceptability of delivering iCBT to a sample of at-home seniors who receive non-skilled home care. Home care workers who care for these seniors are recruited to provide assistance for completing iCBT. We hypothesize that iCBT is an acceptable and feasible intervention for treating depression among at-home seniors.
Depression is one of the most common and debilitating conditions among older adults. At-home
seniors, also called homebound seniors, are older adults who are confined to a bed or chair
and are unable to get about outdoors. Medical morbidity, disability, cognitive impairment,
pain, and social isolation are known risk factors for depression that are prevalent among
at-home seniors. Epidemiological and community-based studies have consistently documented a
high prevalence of depression among at-home seniors. However, depression treatment is often
inaccessible to at-home seniors. The majority of at-home seniors with depression do not
receive adequate treatment, with the dominant treatment modality being medication.
Successfully treating late-life depression requires a multi-component treatment program
beyond medication. Besides, medication non-adherence is common due to concerns of side
effects and preferences for other treatment modalities such as counseling. However,
office-based psychotherapy is out of reach for at-home seniors who often require assistance
for transportation. In addition, older adults prefer home-based treatment and counseling, and
consideration of their preference may lead to better treatment outcomes.
Online therapy (iCBT) is an evidence-based approach for treating depression.
Cognitive-behavioral therapy (CBT) is the gold standard of psychotherapy for depression in
both young and older adults. Internet-based CBT (iCBT) delivers CBT via d websites or
dedicated apps on mobile devices or tablets. iCBT can be self-administered or guided by a
therapist. Its strengths include low-cost, accessibility, and ability to tailor to individual
needs while maintaining fidelity. Meta-analyses have shown that iCBT is equivalent to
face-to-face CBT in its effectiveness for treating depression. Emerging evidence suggests
that iCBT may actually be more effective for older adults, because they are more likely to
adhere to treatment than their younger counterparts. Despite the benefits of iCBT, most older
adults do not use iCBT, possibly due to limited opportunities accessing iCBT programs and
technological challenges.
This project explores the feasibility of implementing iCBT in non-skilled home care. Home
care workers provide personal care and companionship to older adults in need of assistance
with daily activities, housekeeping, medication management, and transportation. Home care is
provided full-time, part-time, intermittently, or even around the clock to address the
recipient's long-term care needs. Home-based care provides a naturalized and accessible
setting, and frequent home visits over an extended period offer opportunities for prolonged
engagement and symptom monitoring. Research shows that iCBT programs with human support are
more effective than self-guided programs. For at-home seniors, home care workers represent an
untapped resource of human support and can be trained to provide technical assistance for
at-home seniors with limited computer literacy, addressing technological challenges
associated with iCBT use. Moreover, home care workers can facilitate the completion of
behavioral activation activities (e.g., drive a client to attend a social activity), which is
critical in realizing the effectiveness of CBT. In addition, participation in training and
intervention may also benefit the home care workers themselves by improving job satisfaction,
pride, and retention. However, Studies have not tested iCBT with at-home seniors receiving
home care. Protocols for implementing iCBT in home care also do not exist. Issues regarding
screening, supervision, and referrals need to be addressed and standardized. In addition, we
need to develop strategies to address implementation barriers at the patient, provider, and
organization levels to achieve sustained impact.
This pilot feasibility study is a pragmatic trial of iCBT among a sample of diverse at-home
seniors receiving non-skilled home care. Guided by the Replicating Effective Programs
framework, this study aims to develop materials to package an existing, evidence-based iCBT
program called Beating the Blues for testing in a sample of at-home seniors receiving home
care. The primary aim of the study is to test whether iCBT is an acceptable treatment
modality for at-home seniors with varying levels of technology competency. An exploratory aim
is to examine whether it is feasible to train home care workers to assist seniors with iCBT
completion. Findings from this pilot study will gather information regarding barriers to
implement iCBT in non-skilled home care at the provider- (home care workers) and the patient-
(at-home seniors) levels. If the results from this study are promising, subsequent efforts
will be devoted to address implementation barriers at the organizational (home care agencies)
level.
The study is a single-group open trial. Study materials (measurements, participant workbook)
will be piloted tested with 2 subjects, who will not participate in the full trial. The
targeted sample size for the full trial is 28. A sample size of 23 provides a power of 0.95
to detect a significant effect size of d=.8 from paired-sample t-test (G*Power, 3.1 version).
A proposed sample size of 28 therefore has sufficient power to detect the projected effect
size.
Study subjects will be recruited from home-care agencies, meals-on-wheels, and senior
apartment buildings in Ann Arbor and surrounding areas.
After being screened and consented, subjects will receive a comprehensive baseline
assessment. Subjects have the choice of receiving assistance from their home care worker,
assistance from a member of the research team, or work on the iCBT program on their own. If
subjects prefer to work on the iCBT program with their home care workers, their workers will
also been consented and receive a training. After their workers finish the required training,
subjects will then start treatment. Research team will supply a tablet and prepaid data
packages to subjects if they don't have access to a working device or internet package.
Subjects are told that they have 3 months to use the online program. Subjects will receive a
comprehensive post-test assessment once they complete the entire program or at the end of the
3-month period, whichever occurs first. Subjects will also be asked to participate in a short
individual interview during post-test. All assessments with subjects will take place at their
home. The structured part of the comprehensive baseline and post-test includes three parts:
an online self-administered survey, a clinical interview, and Montreal Cognitive Assessment
(MoCA) test for cognitive impairment using the MoCA app. In addition to these scheduled
assessments, Beating the Blues, the iCBT program used in the study, has built-in assessments
(PHQ-9 and GAD-7) at the start of session 1 and the end of session 3, 5, 7, & 8.
Survey data will be recorded and managed using Qualtrics.
Post-treatment analysis will involve an intention-to-treat design where missing data are
addressed by carrying forward data previously collected. Primary outcomes include Patient
Health Questionnaire (PHQ-9) for depressive symptoms, number of sessions completed, and
program satisfaction/acceptability. Difference in PHQ-9 between session 1 and post-test will
be calculated and tested. Session 1 PHQ-9 score will be used to assure consistency in time
lapsed up until post-test. Secondary outcomes include Generalized Anxiety Disorder (GAD-7)
for anxiety and Montreal Cognitive Assessment (MoCA) for cognitive impairment. Difference in
GAD-7 between session 1 and post-test will be calculated and tested. Difference in MoCA score
between baseline and post-test will be tested. Paired-sample t-test will be used to detect
statistically significant difference. Effect sizes (Cohen's d) and 95% confidence intervals
will be calculated. Statistical analyses will be conducted using Stata 15.1 SE version.
This study is supported by an Investigator-Initiated Grant from the Blue Cross Blue Shield of
Michigan Foundation and a grant from the Michigan Department of Health and Human Services.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |