Improving Mood in Assisted Living Settings

Depressive Symptoms Clinical Trial

Official title:

Improving Mood in Assisted Living Settings Using a Cognitive Training Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763216
• Other study ID #: 201208786
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: November 6, 2020

Study information

• Verified date: November 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: November 6, 2020
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinical Depression
• Depression
• Depressive Symptoms

Intervention

Other:
• Road Tour
Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.
• Boatload of Crosswords
Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.

Locations

Country	Name	City	State
United States	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	Petersen Commons Assisted Living Community of Marycrest	Davenport	Iowa
United States	Ridgecrest Village	Davenport	Iowa
United States	Senior Star at Elmore Place	Davenport	Iowa
United States	Silvercrest Garner Active Retirement Community	Davenport	Iowa
United States	Valley View Village	Des Moines	Iowa
United States	Wesley Acres	Des Moines	Iowa
United States	The Kensington Assisted Living Community	Fort Madison	Iowa
United States	Emerson Point	Iowa City	Iowa
United States	Legacy Senior Living Community	Iowa City	Iowa
United States	Melrose Meadows	Iowa City	Iowa
United States	Oaknoll Retirement Residence	Iowa City	Iowa
United States	University of Iowa Colleges of Nursing and Public Health	Iowa City	Iowa
United States	Bishop Drumm--Martina Place	Johnston	Iowa
United States	Summit Pointe	Marion	Iowa
United States	The Villages at Marion	Marion	Iowa
United States	Iowa Veteran's Home	Marshalltown	Iowa
United States	Lutheran Living Senior Campus	Muscatine	Iowa
United States	Manor Health Care Center	Sigourney	Iowa
United States	Prairie Hills Assisted Living	Tipton	Iowa
United States	Friendship Village Retirement Community	Waterloo	Iowa
United States	Simpson Memorial Home, Inc.	West Liberty	Iowa
United States	Highland Ridge Senior Living Community	Williamsburg	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Marianne Smith

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Patient Health Questionnaire (PHQ-9)	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.	baseline, post-training, six months, one year
Primary	Changes in the Centers for Epidemiological Studies Depression (CESD) 12-item scale	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.	baseline, post-training, six months, one year
Secondary	Changes in the Useful Field of View (UFOV)	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.	baseline, post-training, six months, one year
Secondary	Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale	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.	baseline, and one year
Secondary	Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12)	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.	post-training and six months
Secondary	Changes in the Brief Pain Invention (BPI)	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.	baseline, post-training, six months, one year
Secondary	Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire	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.	baseline, post-training, six months, one year