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NCT Number: NCT06753578

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acceptance and Commitment Therapy (ACT)

Behavioral

Acceptance and Commitment Therapy (ACT); Quality of Life (QOL); Mild Cognitive Impairment (MCI); cognitive function; elderly; psychological flexibility.

Standard Care

Behavioral

standard care

Primary outcomes

  1. Change in Quality of Life as measured by the QOL-AD scale

    Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up

    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

  2. Change in cognitive function as measured by the Mini-Mental State Examination (MMSE)

    Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up

    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

Secondary outcomes

  1. Psychological flexibility as measured by the Acceptance and Action Questionnaire (AAQ-II)

    Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up

    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

  2. Social engagement as measured by a standardised engagement assessment tool

    Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up

    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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Marqués de Valdecilla

Other

Registry information

Acronym: EACT

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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