Improving Mood in Assisted Living Settings
- Conditions
- Clinical DepressionDepressive Symptoms
- Registration Number
- NCT01763216
- Lead Sponsor
- Marianne Smith
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
- 55 years old or older
- reside in one of the participating AL settings or affiliated sites
- capable of providing informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in the Centers for Epidemiological Studies Depression (CESD) 12-item scale baseline, post-training, six months, one year A shorter version of the original CESD-20 that has been a gold standard for screening for depression in epidemiological, field, and public survey studies, and has very high reliability and validity. Because the CESD-12 was used in the Iowa Healthy and Active Minds Study (IHAMS) and the Advanced Cognitive Training for Independent Vital Elderly (ACTIVE) study, direct comparison of depression outcomes among AL participants in this study and community-dwelling subjects in those studies can occur. CESD-12 is composed of short statements scored from 0=rarely or none of time (less than 1 day per week) to 3=all of the time (5-7 days per week) for a score range of 0-36. The cut-off score for suspected clinical depression on the CESD-12 is 9 or more points, which is equivalent to 16 or more points for the CESD-20.
Changes in the Patient Health Questionnaire (PHQ-9) baseline, post-training, six months, one year The PHQ-9 items reflect the nine Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for major depression and are rated from 0=not at all to 3=nearly every day for a total score range of 0-27. Established cut-points are: 0-4= minimal depression; 5-9=mild depression; 10-14=moderate depression; 15 or greater = severe depression. Scores of 10 or more indicate suspected clinically significant depression. The PHQ-9 facilitates direct assessment of two hallmarks of major depression (prominent dysphoria and anhedonia) and comparison to another body of late life depression research.
- Secondary Outcome Measures
Name Time Method Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale baseline, and one year The SF-36 is the most widely used measure of health-related quality of life, and consists of 36 items that make up eight subscales. Its reliability and validity are well established in the US and elsewhere. Subscale scores range from 0 for worst health to 100 for best health.
Changes in the Useful Field of View (UFOV) baseline, post-training, six months, one year The UFOV is well-established, has high reliability and validity, and is the gold standard for measuring visual processing speed. UFOV includes three subtests-stimulus identification, divided attention, and selective attention-each automatically scored from 17-500 ms reflecting the shortest exposure time at which the participant could correctly perform each subtest 75% of the time, with a composite ms outcome score ranging from 51-1500 ms. Scores represent the shortest display duration with which the respondent performs accurately on 75% of the trials.
Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12) post-training and six months The SF-12 is an abbreviated version of the SF-36 health-related quality of life measure, and consists of 12 items that make up eight subscales. Its reliability and validity are well established in the US and elsewhere. Subscale scores range from 0 for worst health to 100 for best health. It is used here at post-training and six months to minimize respondent fatigue.
Changes in the Brief Pain Invention (BPI) baseline, post-training, six months, one year The Brief Pain Inventory (BPI) multi-item severity and interference scales have been adopted for telephone use. It consists of likert scaled and thermometer response options. We will examine mean changes in both scales over time, as well as declines in pain scores \> 30%, which are considered clinically meaningful.
Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire baseline, post-training, six months, one year The highly reliable and valid 7-item Generalized Anxiety Disorder (GAD-7) scale rates the DSM-IV criteria for GAD with a response set ranging from 0=not at all to 3=nearly every day. Cut-points for the GAD-7 are comparable to the PHQ-9, with 0-4= minimal anxiety; 5-9=mild anxiety; and 10 or more=clinically significant anxiety.
Trial Locations
- Locations (32)
Lakeview Village Retirement
🇺🇸Amana, Iowa, United States
The Fountains Senior Community Living
🇺🇸Bettendorf, Iowa, United States
Carlise Center for Assisted Living
🇺🇸Carlisle, Iowa, United States
Western Home Communities
🇺🇸Cedar Falls, Iowa, United States
Irving Point Affordable Assistant Living
🇺🇸Cedar Rapids, Iowa, United States
Keystone Cedars
🇺🇸Cedar Rapids, Iowa, United States
Meth-Wick Community
🇺🇸Cedar Rapids, Iowa, United States
Prairie Hills at Cedar Rapids
🇺🇸Cedar Rapids, Iowa, United States
Bickford of Clinton
🇺🇸Clinton, Iowa, United States
Woodlands Creek Active Retirement Community
🇺🇸Clive, Iowa, United States
Scroll for more (22 remaining)Lakeview Village Retirement🇺🇸Amana, Iowa, United States