Happy@Home: Delivering iCBT With Homecare Workers to At-Home Seniors

NCT04267289 | Completed

• 1 other identifier: 2748II
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire-9 Items (PHQ-9)

  PHQ-9 for depressive symptoms, total score ranges from 0 to 27, higher scores indicate worse depressive symptoms

  Change from baseline PHQ9 at end of treatment (3 months after the start of treatment)

• # of sessions completed

  \# of Beating the Blues sessions completed at the end of 3 months

  Up to 3 months after the start the treatment

• Acceptability

  Treatment acceptability scale, has a total of 10 questions, total score ranges from 10 to 50, higher scores indicate higher acceptability

  Up to 3 months after the start the treatment

• Satisfaction with the treatment program

  self rated satisfaction with the program, score ranges from 1 to 10. Higher score indicates higher satisfaction.

  Up to 3 months after the start the treatment

Secondary Outcomes (3)

• Generalized Anxiety Disorder-7 (GAD-7)

  Change from baseline GAD7 at end of treatment (3 months after the start of treatment)

• Montreal Cognitive Assessment (MoCA)

  Change from baseline MoCA at end of treatment (3 months after the start of treatment)

• EQ5D-5L

  Change from baseline EQ5D at end of treatment (3 months after the start of treatment)

Study Arms (1)

iCBT treatment group

EXPERIMENTAL

Subjects were given license to use Beating the Blues, a commercially available iCBT program. Subjects were given 3 months to use the program.

Behavioral: Beating the Blues

Interventions

Beating the Blues BEHAVIORAL

Automated, cognitive behavioral therapy delivered via a website. There are 8 sessions, each taking one to 1.5 hours to complete. Sessions are prerecorded and sequenced. Sessions are based on the principles of cognitive behavioral therapy and include techniques such as cognitive restructuring and behavioral activation. The entire program takes about 8 to 12 weeks to complete.

Also known as: Internet based cognitive behavioral therapy

iCBT treatment group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• have received home care for ≥ 1 month and anticipate continued care for ≥ 3 months
• have at least mild depressive symptoms (PHQ-9≥5)
• speak English.

You may not qualify if:

• Currently receiving psychotherapy
• Have a psychotic disorder (BPRS)
• Have active suicidal ideation based on endorsement of PHQ-9 item 9 (other than not at all)
• Severe cognitive impairment, assessed as having ≥ 3 errors on the 6-item Mini mental state exam
• Have a planned hospital admission in the next 3 months of enrollment

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Xiang X, Kayser J, Sun Y, Himle J. Internet-Based Psychotherapy Intervention for Depression Among Older Adults Receiving Home Care: Qualitative Study of Participants' Experiences. JMIR Aging. 2021 Nov 22;4(4):e27630. doi: 10.2196/27630.

  PMID: 34813491 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Xiaoling Xiang, PhD, MSW

  University of Michigan School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: May 30, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)