Promoting Independence With Compensatory Cognitive Rehabilitation

NCT04820335 | Completed

• 1 other identifier: K23AG070185
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD) is one of the leading causes of disability in older adults. Because pharmacological approaches do not seem to prevent or slow the disease, clinicians need non-pharmacological interventions that might help people with AD remain independent for as long as possible. This study aims to evaluate the effects of a new behavioral treatment, the Structured External Memory Aid Treatment (SEMAT), for adults with mild cognitive impairment (MCI) designed to promote independent living skills by explicitly teaching the use of strategies and tools to compensate for cognitive weaknesses. Aim 1: Evaluate the efficacy of the SEMAT for improving functional performance in a pilot randomized trial. Aim 2: Evaluate demographic, clinical, and neuropsychological predictors of treatment adherence. Aim 3: Develop and refine the SEMAT manual and other materials for training future interventionists.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Changes in Memory Based Everyday Function

  The Everyday Cognition (ECog) is a questionnaire to assess improvements in memory based everyday functioning. The ECog comprises of 39 items on which the participant's current level of everyday functioning is compared to a pervious level. Items are rated on a four-point scale: 1= better or no change; 4= consistently much worse. Higher scores indicate greater functional limitations. The self-report and informant versions will be administered.

  Baseline to immediately post-treatment

• Changes in Memory Based Compensation

  Everyday Compensation (EComp) is a questionnaire to assess improvements in memory based compensation. The EComp comprises of 41 items on which the participant's current level of strategy use is compared to a pervious level. Items are rated on a four-point scale: 1= never; 4= always. Higher scores indicate greater strategy use. The self-report and informant versions will be administered.

  Baseline to immediately post-treatment

Secondary Outcomes (8)

• Changes in Everyday Strategy Use

  Baseline to immediately post-treatment

• Changes in Cognitive Abilities

  Baseline to immediately post-treatment

• Changes in Quality of Life

  Baseline to immediately post-treatment

• Changes in Executive Functioning Skills

  Baseline to immediately post-treatment

• Changes in Self Efficacy

  Baseline to immediately post-treatment

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

Participants will complete 7, 60-minute SEMAT sessions over 7 weeks with their group.

Behavioral: Structured External Memory Aid Treatment (SEMAT)

Delayed Treatment Control

NO INTERVENTION

Participants will not receive the intervention immediately. After 8 weeks, participants in this arm will complete the SEMAT. This is not a crossover design, because the treatment effects from those in the immediate treatment group can not be taken away.

Interventions

Structured External Memory Aid Treatment (SEMAT) BEHAVIORAL

During the 7 weeks of treatment, the interventionist will teach 3 categories of external memory aids (calendars, timers, notes) following an already-developed detailed treatment manual (described here briefly). Week 1: Introduction of External Memory Aid Treatment and Person-Centered Goal Setting. Weeks 2-7. In the next six weeks, three categories of external memory aids will be taught: calendars, timers, and notes. The focus of the first session will be how to use the strategies, and the second session will build awareness of when to use these strategies during everyday tasks. Within each category, three types of strategies will be taught to participants. Within each session, learning phases will follow training stages from compensatory learning theory: 1) acquisition phase, 2) application phase, and 3) an adaptation phase.

Also known as: Compensatory Cognitive Rehabilitation

Immediate Treatment Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• English Speaking
• Functional Vision and Hearing to Complete Phone Screen
• not taking or stable ( \>2 months) on nootropic meds
• amnestic mild cognitive impairment from probable Alzheimer's disease

You may not qualify if:

• History of major psychiatric disorder (e.g. schizophrenia)
• Untreated major depression
• History of medical diseases that are related to cognitive impairment
• current participation in another clinical trial related to memory
• major auditory, visual, or motor impairment that would affect their ability to participate in the study
• substance use disorder in the past 5 years

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 29, 2021
• Study Start: February 1, 2022
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)