Homebound Elderly People Psychotherapeutic Intervention

Mild Cognitive Impairment Clinical Trial

— HEPPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967378
• Other study ID #: HEPPI-CINEICC
• Secondary ID: SFRH/BD/146170/2
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: University of Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State
• Cognitive Dysfunction
• Depression
• Depressive Symptoms
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Portugal	Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
University of Coimbra	Foundation for Science and Technology (FCT)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of HEPPI program	Measured by recruitment rate	Baseline
Primary	Feasibility of HEPPI program	Measured by drop-out rate	Immediately after the intervention
Primary	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	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
Secondary	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
Secondary	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
Secondary	Changes in Sustained Attention	Measured by Coding-Digit Symbol (WAIS-III) - Higher scores indicate a better outcome	Baseline, 1 week after the intervention
Secondary	Changes in Depressive Symptomatology	Measured by Geriatric Depression Scale-30 (GDS-30) - Lower scores indicate a better outcome	Baseline, 1 week after the intervention
Secondary	Changes in Anxious Symptomatology	Measured by Geriatric Anxiety Inventory (GAI) - Lower scores indicate a better outcome	Baseline, 1 week after the intervention
Secondary	Changes in Subjective Memory Complaints	Measured by Subjective Memory Complaints Scale (QSM) - Lower scores indicate a better outcome	Baseline, 1 week after the intervention
Secondary	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
Secondary	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