Clinical trial NCT04967378: Homebound Elderly People Psychotherapeutic Intervention
Official title: Feasibility, Acceptability, and Preliminary Efficacy Study of a Cognitive-Emotional Intervention Program for Homebound Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Depressive Symptoms
Anxiety State
Keywords: Homebound Older Adults
Mild Cognitive Impairment
Depressive and Anxious Symptomatology
Cognitive-Emotional Intervention Program
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2021-07-19
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility of HEPPI program
timeFrame: Baseline
measure: Feasibility of HEPPI program
timeFrame: Immediately after the intervention
measure: Acceptability of HEPPI program
timeFrame: 1 week after the intervention
Secondary outcomes:
measure: Changes in General Cognitive Function
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Verbal Memory
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Episodic Memory
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Sustained Attention
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Depressive Symptomatology
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Anxious Symptomatology
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Subjective Memory Complaints
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Quality of Life
timeFrame: Baseline, 1 week after the intervention
measure: Changes in Functional Capacity
timeFrame: Baseline, 1 week after the intervention
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Study officials:
References: