HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults

Mild Cognitive Impairment Clinical Trial

— HEPPI  

Official title:

HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05499767
• Other study ID #: HEPPIEfficacy/CINEICC
• Secondary ID: SFRH/BD/146170/2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University of Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this research is to assess the efficacy of a 10-week home-delivered cognitive-emotional intervention program for homebound older adults presenting Mild Cognitive Impairment (MCI) and depressive and/or anxiety symptoms. The Homebound Elderly People Psychotherapeutic Intervention (HEPPI) combines cognitive training, psychotherapeutic techniques, and compensatory strategy training, and was designed to optimize memory function and to reduce depressive or anxious symptomatology of these older adults.

A two-arm randomized controlled trial (RCT) is conducted to investigate the efficacy of the HEPPI among the homebound older population.

Description:

The present study aims to assess the efficacy of a cognitive-emotional intervention (the HEPPI program) for homebound older adults with MCI and depressive and/or anxious symptomatology.

The research design of the trial followed the methodological recommendations for conducting goropsychoterapy research. Moreover, a pilot RCT was conducted prior to the present RCT, in order to assess the feasibility, acceptability, and preliminary efficacy of the HEPPI. Appropriate adjustments to the HEPPI protocol were carried out considering the results.

The present study is a two-arm RCT comparing the intervention condition (HEPPI) to a treatment as usual (TAU) control group. The sample includes community-dwelling older adults who do not leave home more often than once a week. Homebound older adults are recruited from the community through contact with their health care networks. A minimum number of 79 participants per condition will be required (N=158). Accounting for an expected 20% attrition rate, an anticipated sample of 198 participants will be enrolled in the study. Participants who demonstrate interest in the study are informed of the goals and procedures of the research and asked to provide informed consent before eligibility assessment. Eligible participants are randomly assigned to the HEPPI or the TAU group.

Homebound older adults are asked to complete baseline, post-intervention, and 3-month follow-up assessments. Assessments include neuropsychological tests to assess cognition function, psychological health, subjective memory complaints, quality of life, functional status, perceived loneliness, and personality. The study procedures take place at the participants' homes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 31, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Homebound older adults aged 65 years and older;

• MoCA score 1 to 1.5 standard deviation below the mean for age- and education- adjusted norms;

• FCSRT total immediate and delayed recall scores = 35 and = 12, respectively;

• Presence of subjective memory complaints (SMCS score = 3);

• Presence of depressive symptomatology (GDS-30 score = 11);

• Presence of anxious symptomatology (GAI score = 8);

• No significant impact from cognitive impairment on daily functional capacity;

• Residence in mainland Portugal;

Exclusion Criteria:

• Presence or history of significant neurological conditions;

• Presence of severe psychiatric illnesses;

• Presence of comorbid medical conditions associated with cognition decline;

• Use of psychotropic medication for less than three months;

• 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
Homebound Elderly People Psychotherapeutic Intervention

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
Other	Personality Traits	Measured by NEO Five-Factor Inventory (NEO-FFI)	Baseline
Primary	Changes in Episodic Memory	Logical Memory of the Wechsler Memory Scale-III (LM) | Higher scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Primary	Changes in Depressive Symptomatology	Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Primary	Changes in Anxious Symptomatology	Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Secondary	Changes in General Cognitive Function	Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) | Higher scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Secondary	Changes in Attentional Control	Measured by Digit Symbol-Coding of the Wechsler Adult Intelligence Scale-III (DSC) | Higher scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Secondary	Changes in Subjective Memory Complaints	Measured by Subjective Memory Complaints Scale (SMCS) | Lower scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Secondary	Changes in Perceived Quality of Life	Measured by European Portuguese World Health Organization Quality of Life-Old Module (WHOQOL-OLD) | Higher scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Secondary	Changes in Functional Status	Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) | Lower scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up
Secondary	Changes in Loneliness	Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up