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

NCT05499767 | Completed

• 2 other identifiers: HEPPIEfficacy/CINEICCSFRH/BD/146170/2019
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Depressive Symptoms; Anxiety State

Keywords

Homebound Older Adults; Mild Cognitive Impairment; Depressive and Anxious Symptomatology; Cognitive-Emotional Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Changes in General Cognitive Function

  Baseline, post-intervention, and 3-month follow-up

• Changes in Attentional Control

  Baseline, post-intervention, and 3-month follow-up

• Changes in Subjective Memory Complaints

  Baseline, post-intervention, and 3-month follow-up

• Changes in Perceived Quality of Life

  Baseline, post-intervention, and 3-month follow-up

• Changes in Functional Status

  Baseline, post-intervention, and 3-month follow-up

Other Outcomes (1)

• Personality Traits

  Baseline

Study Arms (2)

HEPPI

EXPERIMENTAL

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

Behavioral: HEPPI

Treatment as Usual (TAU)

NO INTERVENTION

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

Interventions

HEPPI BEHAVIORAL

Homebound Elderly People Psychotherapeutic Intervention

HEPPI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

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

Coimbra, Portugal

Location

Related Publications (2)

• 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.

  PMID: 38101250 DERIVED

• 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.

  PMID: 37747057 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)