HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults (HEPPI)
Primary Purpose
Mild Cognitive Impairment, Depressive Symptoms, Anxiety State
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
HEPPI
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention, Randomized Controlled Trial
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.
Sites / Locations
- Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HEPPI
Treatment as Usual (TAU)
Arm Description
The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.
The TAU group receives access to HEPPI at the end of the study.
Outcomes
Primary Outcome Measures
Changes in Episodic Memory
Logical Memory of the Wechsler Memory Scale-III (LM) | Higher scores indicate a better outcome
Changes in Depressive Symptomatology
Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome
Changes in Anxious Symptomatology
Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome
Secondary Outcome Measures
Changes in General Cognitive Function
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) | Higher scores indicate a better outcome
Changes in Attentional Control
Measured by Digit Symbol-Coding of the Wechsler Adult Intelligence Scale-III (DSC) | Higher scores indicate a better outcome
Changes in Subjective Memory Complaints
Measured by Subjective Memory Complaints Scale (SMCS) | Lower scores indicate a better outcome
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
Changes in Functional Status
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) | Lower scores indicate a better outcome
Changes in Loneliness
Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome
Full Information
NCT ID
NCT05499767
First Posted
August 9, 2022
Last Updated
May 8, 2023
Sponsor
University of Coimbra
Collaborators
Foundation for Science and Technology (FCT)
1. Study Identification
Unique Protocol Identification Number
NCT05499767
Brief Title
HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
Acronym
HEPPI
Official Title
HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Foundation for Science and Technology (FCT)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Depressive Symptoms, Anxiety State
Keywords
Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention, Randomized Controlled Trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEPPI
Arm Type
Experimental
Arm Description
The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
The TAU group receives access to HEPPI at the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
HEPPI
Intervention Description
Homebound Elderly People Psychotherapeutic Intervention
Primary Outcome Measure Information:
Title
Changes in Episodic Memory
Description
Logical Memory of the Wechsler Memory Scale-III (LM) | Higher scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Depressive Symptomatology
Description
Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Anxious Symptomatology
Description
Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Secondary Outcome Measure Information:
Title
Changes in General Cognitive Function
Description
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) | Higher scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Attentional Control
Description
Measured by Digit Symbol-Coding of the Wechsler Adult Intelligence Scale-III (DSC) | Higher scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Subjective Memory Complaints
Description
Measured by Subjective Memory Complaints Scale (SMCS) | Lower scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Perceived Quality of Life
Description
Measured by European Portuguese World Health Organization Quality of Life-Old Module (WHOQOL-OLD) | Higher scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Functional Status
Description
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) | Lower scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Title
Changes in Loneliness
Description
Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome
Time Frame
Baseline, post-intervention, and 3-month follow-up
Other Pre-specified Outcome Measures:
Title
Personality Traits
Description
Measured by NEO Five-Factor Inventory (NEO-FFI)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
City
Coimbra
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
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