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Clinical Trials/NCT04967378
NCT04967378
Completed
N/A

Feasibility, Acceptability, and Preliminary Efficacy Study of a Cognitive-Emotional Intervention Program for Homebound Older Adults With Mild Cognitive Impairment

University of Coimbra1 site in 1 country51 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University of Coimbra
Enrollment
51
Locations
1
Primary Endpoint
Feasibility of HEPPI program
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study aims to develop, implement, and assess the feasibility, acceptability, and preliminary efficacy of a 10-week structured and individualized cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment (MCI) and with depressive and/or anxiety symptoms. Homebound Elderly People Psychotherapeutic Intervention (HEPPI) is designed to maintain or improve memory functioning, reduce depressive and/or anxiety symptoms, and help participants to compensate or adapt to impaired cognitive performance, improving their quality of life and their subjective perception of memory and health.

Detailed Description

There is currently a significant increase in the number of homebound older adults due to multiple physical, psychological, and/or social vulnerabilities, who require in-home support services. A substantial proportion of these elderly people has MCI - more specifically amnesic MCI (aMCI) - often associated with depressive and/or anxious symptomatology. Although the general cognitive functioning and the daily functional capacity is relatively preserved, the cognitive impairment and the emotional difficulties have a significant negative impact in their quality of life. MCI is a pathological risk condition to develop dementia, more specifically Alzheirmer's disease. Thus, a significant part of homebound older adults is in the prodromal phase of this disease, which represents a key moment for its early detection and for the application of appropriate interventions. Indeed, older adults are able to learn new information and memory strategies, as well as adapt their behavior, allowing them to benefit from such interventions. The intervention programs focusing on cognition and MCI related symptomatology have revealed to maintain or improve the mnesic abilities and attention capacity in older people, as well as reduce depressive and/or anxiety symptoms. However, despite the growing research, there are few studies applying and assessing the effectiveness of these programs in homebound older adults. Therefore, the purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of the HEPPI program - a cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment and with depressive and/or anxiety symptoms. A sample of homebound older adults over 65 years old with aMCI and with depressive and/or anxiety symptoms is being recruited through contact with national entities that identify and work directly with this population, and through contact with their social support network. Participants who demonstrate interest are informed about the aims and procedures of the study, and asked to sign an informed consent form before eligibility assessment. Eligible participants are randomly assigned to either an experimental group, who receive the intervention, or a waiting-list control group, who will receive access to HEPPI program at the end of the study. Both groups complete a neuropsychological protocol to assess measures of cognition, psychological health, subjective memory complaints, quality of life, personality, and functional capacity. This protocol is applied in two different moments: at baseline (PRE) and one week after the intervention (POS1). The study procedures take place at the participants' homes.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andreia Jesus

Integrated non-PhD member

University of Coimbra

Eligibility Criteria

Inclusion Criteria

  • Homebound older adults over 65 years old;
  • Presence of aMCI;
  • Presence of depressive and/or anxiety symptoms;
  • Residence in mainland Portugal;
  • Provision of written informed consent by participants.

Exclusion Criteria

  • Presence of a dementia diagnosis;
  • Presence or history of other significant neurological conditions;
  • Presence of severe psychiatric illnesses;
  • Presence of comorbid medical conditions associated with cognition decline;
  • Use of psychotropic medication;
  • Presence of alcoholism or toxicomania;
  • Significant impairment of vision, hearing, communication or manual dexterity.

Outcomes

Primary Outcomes

Feasibility of HEPPI program

Time Frame: Immediately after the intervention

Measured by drop-out rate

Acceptability of HEPPI program

Time Frame: 1 week after the intervention

Assessed with a questionnaire that includes questions regarding the participants' satisfaction with the program, their intention to use the program, the usefulness and relevance of the program, and its demandingness.

Secondary Outcomes

  • Changes in Depressive Symptomatology(Baseline, 1 week after the intervention)
  • Changes in Anxious Symptomatology(Baseline, 1 week after the intervention)
  • Changes in General Cognitive Function(Baseline, 1 week after the intervention)
  • Changes in Episodic Memory(Baseline, 1 week after the intervention)
  • Changes in Verbal Memory(Baseline, 1 week after the intervention)
  • Changes in Sustained Attention(Baseline, 1 week after the intervention)
  • Changes in Subjective Memory Complaints(Baseline, 1 week after the intervention)
  • Changes in Quality of Life(Baseline, 1 week after the intervention)
  • Changes in Functional Capacity(Baseline, 1 week after the intervention)

Study Sites (1)

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