Homebound Elderly People Psychotherapeutic Intervention

NCT ID: NCT04967378

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-12-31

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.

Conditions

Mild Cognitive Impairment; Depressive Symptoms; Anxiety State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

HEPPI program

Group Type: EXPERIMENTAL

HEPPI

Intervention Type: BEHAVIORAL

10 weekly individual sessions, 90 minutes each, at the participants' homes. The content of sessions includes psychoeducation, cognitive training, psychotherapeutic intervention, and compensatory strategy training.

Waiting-list control group

Receives access to HEPPI program at the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HEPPI

10 weekly individual sessions, 90 minutes each, at the participants' homes. The content of sessions includes psychoeducation, cognitive training, psychotherapeutic intervention, and compensatory strategy training.

Intervention Type: BEHAVIORAL

Other Intervention Names

Homebound Elderly People Psychotherapeutic Intervention

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Andreia Jesus

Integrated non-PhD member

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)

Coimbra, , Portugal

Countries

Portugal

Other Identifiers

SFRH/BD/146170/2019

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HEPPI-CINEICC

Identifier Type: -

Identifier Source: org_study_id