HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults (NCT05499767) | Clinical Trial Compass
CompletedNot Applicable
HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
Portugal199 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Episodic Memory
Timeframe: Baseline, post-intervention, and 3-month follow-up
2
Changes in Depressive Symptomatology
Timeframe: Baseline, post-intervention, and 3-month follow-up
3
Changes in Anxious Symptomatology
Timeframe: Baseline, post-intervention, and 3-month follow-up