Improving Mood in Assisted Living Settings

NCT01763216 | Completed

• 1 other identifier: 201208786
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 32

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.

Conditions

Depressive Symptoms; Clinical Depression

Keywords

depressive symptoms; clinical depression; visual processing speed; anxiety; pain; health-related quality of life

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Changes in the Useful Field of View (UFOV)

  baseline, post-training, six months, one year

• Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale

  baseline, and one year

• Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12)

  post-training and six months

• Changes in the Brief Pain Invention (BPI)

  baseline, post-training, six months, one year

• Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire

  baseline, post-training, six months, one year

Study Arms (2)

Road Tour

EXPERIMENTAL

Road Tour was designed to improve the efficiency and accuracy of visual information processing and the ability to perform complex visual attention tasks. It focuses on improving the speed and accuracy with which users identify and locate visual information using a divided attention format. Over time, the difficulty and complexity of each task is systematically increased as users attain specified performance criteria. Difficulty is increased by reducing visual stimuli duration, adding visual distracters, increasing similarity between target and distracter stimuli, and presenting visual targets over a broader spatial expanse.

Other: Road Tour

Boatload of Crosswords

SHAM COMPARATOR

Boatload of Crosswords offers the user a choice between three puzzle sizes, three levels of complexity, and varying font sizes. It also provides optional help features that the user may select, like filling in a letter or word to minimize frustration levels often associated with puzzle completion. Boatload of Crosswords was chosen for this study because it is computerized, it is very popular and easy to use, and many older adults enjoy doing crossword puzzles. Boatload of Crosswords, however, does not improve speed of processing because it does not focus on central discrimination and peripheral target location. Indeed, Boatload of Crosswords is not designed to train on any aspect of cognitive ability associated with visual speed of processing.

Other: Boatload of Crosswords

Interventions

Road Tour OTHER

Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.

Also known as: Road Tour at http://www.positscience.com

Road Tour

Boatload of Crosswords OTHER

Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.

Also known as: Boatload of Crosswords at http://www./boatloadpuzzles.com

Boatload of Crosswords

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marianne Smith: lead

Study Sites (32)

Lakeview Village Retirement

Amana, Iowa, 52203, United States

Location

The Fountains Senior Community Living

Bettendorf, Iowa, 52722, United States

Location

Carlise Center for Assisted Living

Carlisle, Iowa, 50047, United States

Location

Western Home Communities

Cedar Falls, Iowa, 50613, United States

Location

Irving Point Affordable Assistant Living

Cedar Rapids, Iowa, 52401, United States

Location

Keystone Cedars

Cedar Rapids, Iowa, 52402, United States

Location

Meth-Wick Community

Cedar Rapids, Iowa, 52405, United States

Location

Prairie Hills at Cedar Rapids

Cedar Rapids, Iowa, 52405, United States

Location

Bickford of Clinton

Clinton, Iowa, 52732, United States

Location

Woodlands Creek Active Retirement Community

Clive, Iowa, 50325, United States

Location

Petersen Commons Assisted Living Community of Marycrest

Davenport, Iowa, 52804, United States

Location

Ridgecrest Village

Davenport, Iowa, 52806, United States

Location

Silvercrest Garner Active Retirement Community

Davenport, Iowa, 52806, United States

Location

Senior Star at Elmore Place

Davenport, Iowa, 52807, United States

Location

Wesley Acres

Des Moines, Iowa, 50312, United States

Location

Valley View Village

Des Moines, Iowa, 50317, United States

Location

The Kensington Assisted Living Community

Fort Madison, Iowa, 52627, United States

Location

Legacy Senior Living Community

Iowa City, Iowa, 52240, United States

Location

University of Iowa Colleges of Nursing and Public Health

Iowa City, Iowa, 52242, United States

Location

Emerson Point

Iowa City, Iowa, 52246, United States

Location

Melrose Meadows

Iowa City, Iowa, 52246, United States

Location

Oaknoll Retirement Residence

Iowa City, Iowa, 52246, United States

Location

Bishop Drumm--Martina Place

Johnston, Iowa, 50131, United States

Location

Summit Pointe

Marion, Iowa, 52302, United States

Location

The Villages at Marion

Marion, Iowa, 52302, United States

Location

Iowa Veteran's Home

Marshalltown, Iowa, 50158, United States

Location

Lutheran Living Senior Campus

Muscatine, Iowa, 52761, United States

Location

Manor Health Care Center

Sigourney, Iowa, 52591, United States

Location

Prairie Hills Assisted Living

Tipton, Iowa, 52772, United States

Location

Friendship Village Retirement Community

Waterloo, Iowa, 50702, United States

Location

Simpson Memorial Home, Inc.

West Liberty, Iowa, 52776, United States

Location

Highland Ridge Senior Living Community

Williamsburg, Iowa, 52361, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marianne Smith, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 8, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 6, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)