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

NCT ID: NCT05499767

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-03-31

Brief 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.

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.

Conditions

Mild Cognitive Impairment; Depressive Symptoms; Anxiety State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

HEPPI

The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.

Group Type: EXPERIMENTAL

HEPPI

Intervention Type: BEHAVIORAL

Homebound Elderly People Psychotherapeutic Intervention

Treatment as Usual (TAU)

The TAU group receives access to HEPPI at the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HEPPI

Homebound Elderly People Psychotherapeutic Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Andreia Jesus

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)

Coimbra, , Portugal

Countries

Portugal

References

Jesus AG, de Lima MP, Vilar M, Pachana NA. Homebound elderly people psychotherapeutic intervention (HEPPI): Exploring the mediating role of loneliness. Arch Gerontol Geriatr. 2024 Mar;118:105308. doi: 10.1016/j.archger.2023.105308. Epub 2023 Dec 3.

Reference Type: DERIVED

PMID: 38101250 (View on PubMed)

Jesus AG, Lima MP, Vilar M, Pachana NA. HEPPI: a randomized controlled trial of the efficacy of a cognitive-emotional intervention for homebound older adults. Aging Ment Health. 2024 Mar-Apr;28(3):491-501. doi: 10.1080/13607863.2023.2260760. Epub 2023 Sep 25.

Reference Type: DERIVED

PMID: 37747057 (View on PubMed)

Other Identifiers

SFRH/BD/146170/2019

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HEPPIEfficacy/CINEICC

Identifier Type: -

Identifier Source: org_study_id