Overview

This trial is active, not recruiting.

Conditions depressive symptoms, clinical depression
Treatments road tour, boatload of crosswords
Sponsor University of Iowa
Start date February 2013
End date February 2017
Trial size 300 participants
Trial identifier NCT01763216, R01-NR013908

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(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.
road tour Road Tour at http://www.positscience.com
Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.
(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.
boatload of crosswords Boatload of Crosswords at http://www./boatloadpuzzles.com
Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.

Primary Outcomes

Measure
Changes in the Patient Health Questionnaire (PHQ-9)
time frame: baseline, post-training, six months, one year
Changes in the Centers for Epidemiological Studies Depression (CESD) 12-item scale
time frame: baseline, post-training, six months, one year

Secondary Outcomes

Measure
Changes in the Useful Field of View (UFOV)
time frame: baseline, post-training, six months, one year
Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale
time frame: baseline, and one year
Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12)
time frame: post-training and six months
Changes in the Brief Pain Invention (BPI)
time frame: baseline, post-training, six months, one year
Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire
time frame: baseline, post-training, six months, one year

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Improving Mood in Assisted Living Settings Using a Cognitive Training Intervention
Principal investigator Marianne Smith, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Iowa.