Healthy Clinical Trial
Official title:
Trial of a Cognitive Intervention for Older Adults
The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.
ACTIVE was a 4-arm, single-blind, randomized controlled trial. The primary objective of
ACTIVE was to test the effectiveness and durability of three distinct cognitive
interventions in improving elders' performance on basic measures of cognition and measures
of cognitively demanding daily activities (e.g., food preparation, driving, medication use,
financial management). These interventions previously had been found successful in improving
cognitive abilities under laboratory or small-scale field conditions.
The three interventions shared common design features: 1) equivalent intensity and duration;
2) small group settings in ten 60-75 minute sessions; 3) focus on strategies for solving
problems, remembering, or responding quickly to information; 4) modeling and demonstration
of strategy usage; 5) practice on exemplar problems; 6) individual and group exercises; 7)
feedback on performance; 8) fostering of self-efficacy regarding performance; 9) applying
strategies to real-world tasks; 10) individualized training experiences, and 11) social
interaction activities. In all three interventions, Sessions 1-5 focused on strategy
instruction and exercises to practice the strategy. Sessions 6-10 provided additional
practice exercises, but no new strategies were introduced. Content for each of the 10
sessions was scripted in a trainer's manual.
Interventions:
1. Reasoning training focused on inductive reasoning, the ability to solve problems that
follow a serial pattern and manifest in executive functioning. Participants were taught
strategies to identify the pattern or sequence required to solve a problem. Training
exercises involved identifying patterns in both laboratory-type reasoning tasks and in
everyday activities, e.g., understanding the pattern in a bus schedule.
2. Memory training focused on verbal episodic memory, which deals with acquisition and
retrieval of information acquired in a particular place at a particular time.
Participants were taught mnemonic strategies for remembering lists and sequences of
items, text material, and main ideas and details of stories and other text-based
information. Training exercises involved recalling laboratory-like episodic memory
tasks as well as tasks related to everyday activities such as recalling a shopping
list.
3. Speed training focused on visual search and the ability to identify and locate visual
information quickly in a divided attention format, with and without distractors.
Participants practiced speeded tasks on a computer, and were allowed to proceed to more
complex tasks, and faster and faster presentation speeds at their own pace.
4. A control group received no training.
In addition, booster training was provided to help participants maintain gains made from
initial training and to further improve cognitive skills. Booster training was provided to a
random sample of approximately 50% of training participants at 11 and 35-36 months after
primary training.
Participant involvement included assessments conducted at baseline, immediately
post-intervention, and at 12, 24, 36 and 60 months. Assessments were conducted in individual
and group sessions. For participants randomized to intervention groups, the interventions
were conducted in small group settings in ten 60-75 minute sessions over a 5-6 week period.
These were behavioral interventions with no pharmacologic component. Eleven months after the
initial training was provided, booster training was offered, in all three intervention arms,
to a randomly selected 60% of initially trained subjects. Booster training was delivered in
four 75-minute sessions over a 2-3 week period.
The primary study hypotheses were:
- Each training group will perform better than the other training and control groups on
their respective primary and proximal outcomes
- Those groups that received booster training will perform better than those that did not
receive booster training on their respective primary and proximal outcomes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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