Clinical trial NCT01763216: Improving Mood in Assisted Living Settings
Official title: Improving Mood in Assisted Living Settings Using a Cognitive Training Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Clinical Depression
Keywords: depressive symptoms
clinical depression
visual processing speed
anxiety
pain
health-related quality of life
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 351
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Late-life depression levels are escalating, and include 24% of all tenants of Assisted Living (AL) settings. A promising, novel intervention is a computerized visual speed of processing training program known as Road Tour. Road Tour has been show to reduce depressive symptom levels and the risk of onset of clinical depression in community dwelling older adults. The investigators hypothesize that similar benefits will accrue to residents in AL settings.

To evaluate this the investigators will use a two-arm, parallel, randomized controlled trial (RCT) comparing Road Tour training to attention control using computerized crossword puzzles among 370 adults 55 years old or older who reside in 15-30 AL settings that are partnering with the investigators.

The investigators hypothesize that Road Tour participants will have improved cognitive processing speed, lower levels of depressive symptoms, lower likelihood of the onset of clinical depression, less anxiety, lower levels of pain symptoms, and better health-related quality of life. These outcomes will be assessed at baseline, post-training, six months, and one year.

Detailed description: Late-life depression is a large, escalating public health problem that often interacts with other health conditions and leads to spiraling disability that simultaneously threatens independence and health-related quality of life (HRQoL), and increases health care costs. Depression affects 24% of older adults in AL settings, but rates of recognition and treatment are low and underscore the need for alternative depression prevention and treatment methods in AL. A novel and promising intervention is a computerized cognitive training program known as Road Tour, which has shown serendipitous benefits for reducing depression symptoms and the onset of suspected clinical depression consistent with Beck's model of cognitive depression. As a self-directed, user-friendly "game", Road Tour overcomes common attitudinal and resource-related barriers that impede treatment in AL settings, and holds considerable promise for interrupting the potential downward spiral of depression-related disability for 1 million AL elders.

The purpose of this study is to evaluate the effect of Road Tour on processing speed, depressive symptoms and suspected clinical depression, and depression-related comorbidities among AL residents in Iowa. The investigators will use a two-arm, parallel, RCT comparing Road Tour training to attention control using computerized crossword puzzles among 370 adults 55 years old or older. The investigators will actively engage 15-30 AL settings and their associated facilities as study partners who implement the training at their sites and assist with the evaluation process. The investigators will help each AL setting develop AL-specific recruitment and enrollment protocols, educate AL staff about the study, and oversee computerized training by participating residents, as well as their family members and AL staff.

The investigators' three specific aims are to: (1) establish the effect of Road Tour on improving cognitive processing speed in AL; (2) evaluate the effect of Road Tour on reducing depressive symptoms and the risk of onset of suspected clinical depression in AL; and, (3) evaluate the effect of Road Tour on the depression-related health outcomes of anxiety, pain, and HRQoL in AL.

Participants will receive 10 hours of computerized training over 5-6 weeks, and 4 hours of booster training at months 5 and 11, for a total of 18 hours of training. Outcomes are changes in the Useful Field of View (UFOV) test for speed of processing (Aim 1), changes in the 12-item Centers for Epidemiologic Studies Depression scale (CESD-12) and the 9-item Patient Health Questionnaire (PHQ-9) for depressive symptoms and suspected clinical depression (Aim 2), and changes in the Short Form 36-item Health-Related Quality of Life (HRQoL) Questionnaire (SF-36) for HRQoL, the Brief Pain Inventory (BPI) for pain, and 7-item Generalized Anxiety Disorder questionnaire (GAD-7) for anxiety (Aim 3). Data will be collected using telephone interviews at baseline, post-training (6-8 weeks), and at 26-weeks and 52-weeks. Linear mixed effect models that adjust for the clustering within AL settings will be used with main effects specified for treatment group and time, as well as their two-way interaction. This study is the first step in evaluating depression-related outcomes of using Road Tour in AL settings.

Eligibility criteria: Inclusion Criteria:

* 55 years old or older
* reside in one of the participating AL settings or affiliated sites
* capable of providing informed consent

Exclusion Criteria:

* self-reported insufficient visual acuity (with glasses) to use a computer
* self-reported physical inability to use a computer mouse and keyboard
* non-English speaking

Primary outcomes:
measure: Changes in the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, post-training, six months, one year
measure: Changes in the Centers for Epidemiological Studies Depression (CESD) 12-item scale
timeFrame: baseline, post-training, six months, one year
Secondary outcomes:
measure: Changes in the Useful Field of View (UFOV)
timeFrame: baseline, post-training, six months, one year
measure: Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale
timeFrame: baseline, and one year
measure: Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12)
timeFrame: post-training and six months
measure: Changes in the Brief Pain Invention (BPI)
timeFrame: baseline, post-training, six months, one year
measure: Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire
timeFrame: baseline, post-training, six months, one year
Other outcomes:
Locations:
city: Amana
country: United States
facility: Lakeview Village Retirement
state: Iowa
city: Bettendorf
country: United States
facility: The Fountains Senior Community Living
state: Iowa
city: Carlisle
country: United States
facility: Carlise Center for Assisted Living
state: Iowa
city: Cedar Falls
country: United States
facility: Western Home Communities
state: Iowa
city: Cedar Rapids
country: United States
facility: Irving Point Affordable Assistant Living
state: Iowa
city: Cedar Rapids
country: United States
facility: Keystone Cedars
state: Iowa
city: Cedar Rapids
country: United States
facility: Meth-Wick Community
state: Iowa
city: Cedar Rapids
country: United States
facility: Prairie Hills at Cedar Rapids
state: Iowa
city: Clinton
country: United States
facility: Bickford of Clinton
state: Iowa
city: Clive
country: United States
facility: Woodlands Creek Active Retirement Community
state: Iowa
city: Davenport
country: United States
facility: Petersen Commons Assisted Living Community of Marycrest
state: Iowa
city: Davenport
country: United States
facility: Ridgecrest Village
state: Iowa
city: Davenport
country: United States
facility: Silvercrest Garner Active Retirement Community
state: Iowa
city: Davenport
country: United States
facility: Senior Star at Elmore Place
state: Iowa
city: Des Moines
country: United States
facility: Wesley Acres
state: Iowa
city: Des Moines
country: United States
facility: Valley View Village
state: Iowa
city: Fort Madison
country: United States
facility: The Kensington Assisted Living Community
state: Iowa
city: Iowa City
country: United States
facility: Legacy Senior Living Community
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Colleges of Nursing and Public Health
state: Iowa
city: Iowa City
country: United States
facility: Emerson Point
state: Iowa
city: Iowa City
country: United States
facility: Melrose Meadows
state: Iowa
city: Iowa City
country: United States
facility: Oaknoll Retirement Residence
state: Iowa
city: Johnston
country: United States
facility: Bishop Drumm--Martina Place
state: Iowa
city: Marion
country: United States
facility: Summit Pointe
state: Iowa
city: Marion
country: United States
facility: The Villages at Marion
state: Iowa
city: Marshalltown
country: United States
facility: Iowa Veteran's Home
state: Iowa
city: Muscatine
country: United States
facility: Lutheran Living Senior Campus
state: Iowa
city: Sigourney
country: United States
facility: Manor Health Care Center
state: Iowa
city: Tipton
country: United States
facility: Prairie Hills Assisted Living
state: Iowa
city: Waterloo
country: United States
facility: Friendship Village Retirement Community
state: Iowa
city: West Liberty
country: United States
facility: Simpson Memorial Home, Inc.
state: Iowa
city: Williamsburg
country: United States
facility: Highland Ridge Senior Living Community
state: Iowa
Study officials:
affiliation: University of Iowa
name: Marianne Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: