Effectiveness of an ACT-Based Cognitive Intervention on Quality of Life and Cognitive Function in Elderly Residents With MCI (EACT)

This study investigates the effects of an Acceptance and Commitment Therapy (ACT)-based cognitive intervention on Quality of Life (QOL) and cognitive function among elderly residents with Mild Cognitive Impairment (MCI) in long-term care settings. The study assesses immediate and long-term impacts on cognitive function, psychological flexibility, social engagement, and overall well-being through structured ACT-based training.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: standard care; Behavioral: Acceptance and Commitment Therapy (ACT)

Detailed Description

This clinical trial explores the impact of an Acceptance and Commitment Therapy (ACT)-based cognitive intervention on Quality of Life (QOL) and cognitive function in elderly residents with Mild Cognitive Impairment (MCI) living in long-term care facilities. The intervention aims to promote psychological flexibility, which is a core process in ACT, and enhance the residents' ability to engage in meaningful activities despite cognitive limitations.

Participants will engage in structured ACT-based training sessions that include mindfulness exercises, values clarification, and commitment strategies designed to improve cognitive engagement, reduce emotional distress, and foster greater social connection. The study measures both the immediate effects following the intervention and the long-term benefits at follow-up periods to evaluate sustained improvements in cognitive performance, psychological resilience, social involvement, and overall well-being.

By focusing on cognitive and emotional strategies, the intervention seeks to empower elderly residents to live more fulfilling and value-driven lives, even in the face of cognitive decline associated with MCI.

• Study Type: Interventional
• Enrollment (Estimated): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Religious congregation
      • Contact: carmen sarabia; Phone Number: +34 942 20 22 39; Email: carmen.sarabia@unican.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Residents aged 65 and older diagnosed with MCI, able to provide informed consent, and residing in participating long-term care facilities.

Exclusion Criteria:

• Individuals with severe cognitive impairment, unstable medical conditions, or psychiatric diagnoses that would interfere with participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care	Behavioral: standard care; standard care
Experimental: ACT	Behavioral: Acceptance and Commitment Therapy (ACT); Acceptance and Commitment Therapy (ACT); Quality of Life (QOL); Mild Cognitive Impairment (MCI); cognitive function; elderly; psychological flexibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life as measured by the QOL-AD scale	Quality of Life will be assessed using the QOL-AD scale, a validated questionnaire for evaluating the quality of life in individuals with cognitive impairment. Changes in mean scores from baseline to each time point will be reported	Baseline, post-intervention (12 weeks), and 6-month follow-up
Change in cognitive function as measured by the Mini-Mental State Examination (MMSE)	Cognitive function will be evaluated using the MMSE, a widely used tool for cognitive assessment. Mean changes in scores from baseline to each time point will be analysed and reported	Baseline, post-intervention (12 weeks), and 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological flexibility as measured by the Acceptance and Action Questionnaire (AAQ-II)	Psychological flexibility will be measured using the AAQ-II, a validated scale assessing an individual's ability to engage with values-based actions despite cognitive and emotional challenges. Mean score changes over time will be reported	Baseline, post-intervention (12 weeks), and 6-month follow-up
Social engagement as measured by a standardised engagement assessment tool	Social engagement will be assessed using a standardised instrument for evaluating participation in meaningful activities and interpersonal connections. Changes in engagement levels will be tracked and reported	Baseline, post-intervention (12 weeks), and 6-month follow-up

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: ACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No