Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Coimbra, Portugal
NCT Number: NCT05499767
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
Coimbra, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Homebound Elderly People Psychotherapeutic Intervention
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
Time frame: Baseline, post-intervention, and 3-month follow-up
Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome
Time frame: Baseline, post-intervention, and 3-month follow-up
Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome
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
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
Time frame: Baseline, post-intervention, and 3-month follow-up
Measured by Subjective Memory Complaints Scale (SMCS) | Lower scores indicate a better outcome
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
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
Time frame: Baseline, post-intervention, and 3-month follow-up
Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome
Time frame: Baseline
Measured by NEO Five-Factor Inventory (NEO-FFI)
University of Coimbra
Other
HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
Acronym: HEPPI
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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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