NCT06753578

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

Same day

First QC Date

November 8, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

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

  • Social engagement as measured by a standardised engagement assessment tool

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

Study Arms (2)

ACT

EXPERIMENTAL
Behavioral: Acceptance and Commitment Therapy (ACT)

Standard care

ACTIVE COMPARATOR
Behavioral: standard care

Interventions

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

ACT
standard careBEHAVIORAL

standard care

Standard care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Religious congregation

Santander, Cantabria, 39008, Spain

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Acceptance and Commitment TherapyStandard of Care

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2024

First Posted

December 31, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2024

Study Completion

June 1, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations