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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Mild Cognitive Impairment; Anxiety State
• Intervention / Treatment: Behavioral: HEPPI

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreia G. Jesus, MSc; Phone Number: +351 239 851 450; Email: jesus.andreia03@gmail.com

Study Locations

• Portugal
  • Coimbra, Portugal
    • Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEPPI; The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.	Behavioral: HEPPI; Homebound Elderly People Psychotherapeutic Intervention
No Intervention: Treatment as Usual (TAU); The TAU group receives access to HEPPI at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 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, post-intervention, and 3-month follow-up
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
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
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
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
Changes in Loneliness	Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome	Baseline, post-intervention, and 3-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personality Traits	Measured by NEO Five-Factor Inventory (NEO-FFI)	Baseline

Collaborators and Investigators

• Sponsor: University of Coimbra
• Collaborators: Foundation for Science and Technology (FCT)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Randomized Controlled Trial; Homebound Older Adults; Depressive and Anxious Symptomatology; Cognitive-Emotional Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Cognitive Dysfunction
• Other Study ID Numbers: HEPPIEfficacy/CINEICC; SFRH/BD/146170/2019 (Other Grant/Funding Number: Foundation for Science and Technology (FCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No