An interventional study of HEPPI in Mild Cognitive Impairment, Depressive Symptoms and Anxiety State, sponsored by University of Coimbra. Completed at 1 site in Portugal. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by University of Coimbra · Not applicable, Interventional, and Supportive care
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 199 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.
Behavioral: HEPPI
The TAU group receives access to HEPPI at the end of the study.
Homebound Elderly People Psychotherapeutic Intervention
Changes in Episodic Memory
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
Changes in Depressive Symptomatology
Measured by Geriatric Depression Scale-30 (GDS-30) \| Lower scores indicate a better outcome
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Anxious Symptomatology
Measured by Geriatric Anxiety Inventory (GAI) \| Lower scores indicate a better outcome
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in General Cognitive Function
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
Changes in Attentional Control
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
Changes in Subjective Memory Complaints
Measured by Subjective Memory Complaints Scale (SMCS) \| Lower scores indicate a better outcome
Time frame: 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
Time frame: 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
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Loneliness
Measured by UCLA Loneliness Scale (UCLA) \| Lower scores indicate a better outcome
Time frame: Baseline, post-intervention, and 3-month follow-up
Personality Traits
Measured by NEO Five-Factor Inventory (NEO-FFI)
Time frame: Baseline
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Coimbra