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Completed

NCT Number: NCT05499767

HEPPI: 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Coimbra, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEPPI

Behavioral

Homebound Elderly People Psychotherapeutic Intervention

Primary outcomes

  1. Changes in Episodic Memory

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Logical Memory of the Wechsler Memory Scale-III (LM) | Higher scores indicate a better outcome

  2. Changes in Depressive Symptomatology

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome

  3. Changes in Anxious Symptomatology

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome

Secondary outcomes

  1. Changes in General Cognitive Function

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) | Higher scores indicate a better outcome

  2. Changes in Attentional Control

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by Digit Symbol-Coding of the Wechsler Adult Intelligence Scale-III (DSC) | Higher scores indicate a better outcome

  3. Changes in Subjective Memory Complaints

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by Subjective Memory Complaints Scale (SMCS) | Lower scores indicate a better outcome

  4. Changes in Perceived Quality of Life

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by European Portuguese World Health Organization Quality of Life-Old Module (WHOQOL-OLD) | Higher scores indicate a better outcome

  5. Changes in Functional Status

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) | Lower scores indicate a better outcome

  6. Changes in Loneliness

    Time frame: Baseline, post-intervention, and 3-month follow-up

    Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome

Other outcomes

  1. Personality Traits

    Time frame: Baseline

    Measured by NEO Five-Factor Inventory (NEO-FFI)

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • Foundation for Science and Technology, Portugal

Registry information

Official study title

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

Acronym: HEPPI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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