Homebound Elderly People Psychotherapeutic Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mild Cognitive Impairment, Depressive Symptoms, Anxiety State

Intervention / Treatment
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* Behavioral: HEPPI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPPI program<br> | Behavioral: HEPPI<br>* 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.<br>* Other names: Homebound Elderly People Psychotherapeutic Intervention;|
| No Intervention: Waiting-list control group<br>Receives access to HEPPI program at the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of HEPPI program | Measured by recruitment rate | Baseline | 
| Feasibility of HEPPI program | Measured by drop-out rate | Immediately after the intervention | 
| Acceptability of HEPPI program | 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. | 1 week after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in General Cognitive Function | Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) - Higher scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Verbal Memory | Measured by Word List I and II (WMS-III) - Higher scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Episodic Memory | Measured by Logical Memory I and II (WMS-III) - Higher scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Sustained Attention | Measured by Coding-Digit Symbol (WAIS-III) - Higher scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Depressive Symptomatology | Measured by Geriatric Depression Scale-30 (GDS-30) - Lower scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Anxious Symptomatology | Measured by Geriatric Anxiety Inventory (GAI) - Lower scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Subjective Memory Complaints | Measured by Subjective Memory Complaints Scale (QSM) - Lower scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Quality of Life | Measured by World Health Organization Quality of Life-OLD Module (WHOQOL-OLD) - Higher scores indicate a better outcome | Baseline, 1 week after the intervention | 
| Changes in Functional Capacity | Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) - Lower scores indicate a better outcome | Baseline, 1 week after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention Program