- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04967378
Homebound Elderly People Psychotherapeutic Intervention (HEPPI)
Feasibility, Acceptability, and Preliminary Efficacy Study of a Cognitive-Emotional Intervention Program for Homebound Older Adults With Mild Cognitive Impairment
Study Overview
Status
Intervention / Treatment
Detailed Description
There is currently a significant increase in the number of homebound older adults due to multiple physical, psychological, and/or social vulnerabilities, who require in-home support services. A substantial proportion of these elderly people has MCI - more specifically amnesic MCI (aMCI) - often associated with depressive and/or anxious symptomatology. Although the general cognitive functioning and the daily functional capacity is relatively preserved, the cognitive impairment and the emotional difficulties have a significant negative impact in their quality of life.
MCI is a pathological risk condition to develop dementia, more specifically Alzheirmer's disease. Thus, a significant part of homebound older adults is in the prodromal phase of this disease, which represents a key moment for its early detection and for the application of appropriate interventions. Indeed, older adults are able to learn new information and memory strategies, as well as adapt their behavior, allowing them to benefit from such interventions.
The intervention programs focusing on cognition and MCI related symptomatology have revealed to maintain or improve the mnesic abilities and attention capacity in older people, as well as reduce depressive and/or anxiety symptoms. However, despite the growing research, there are few studies applying and assessing the effectiveness of these programs in homebound older adults. Therefore, the purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of the HEPPI program - a cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment and with depressive and/or anxiety symptoms.
A sample of homebound older adults over 65 years old with aMCI and with depressive and/or anxiety symptoms is being recruited through contact with national entities that identify and work directly with this population, and through contact with their social support network. Participants who demonstrate interest are informed about the aims and procedures of the study, and asked to sign an informed consent form before eligibility assessment. Eligible participants are randomly assigned to either an experimental group, who receive the intervention, or a waiting-list control group, who will receive access to HEPPI program at the end of the study. Both groups complete a neuropsychological protocol to assess measures of cognition, psychological health, subjective memory complaints, quality of life, personality, and functional capacity. This protocol is applied in two different moments: at baseline (PRE) and one week after the intervention (POS1). The study procedures take place at the participants' homes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Coimbra, Portugal, 3000
- Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Homebound older adults over 65 years old;
- Presence of aMCI;
- Presence of depressive and/or anxiety symptoms;
- Residence in mainland Portugal;
- Provision of written informed consent by participants.
Exclusion Criteria:
- Presence of a dementia diagnosis;
- Presence or history of other significant neurological conditions;
- Presence of severe psychiatric illnesses;
- Presence of comorbid medical conditions associated with cognition decline;
- Use of psychotropic medication;
- Presence of alcoholism or toxicomania;
- Significant impairment of vision, hearing, communication or manual dexterity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HEPPI program
|
10 weekly individual sessions, 90 minutes each, at the participants' homes.
The content of sessions includes psychoeducation, cognitive training, psychotherapeutic intervention, and compensatory strategy training.
Other Names:
|
No Intervention: Waiting-list control group
Receives access to HEPPI program at the end of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of HEPPI program
Time Frame: Baseline
|
Measured by recruitment rate
|
Baseline
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Feasibility of HEPPI program
Time Frame: Immediately after the intervention
|
Measured by drop-out rate
|
Immediately after the intervention
|
Acceptability of HEPPI program
Time Frame: 1 week after the intervention
|
Assessed with a questionnaire that includes questions regarding the participants' satisfaction with the program, their intention to use the program, the usefulness and relevance of the program, and its demandingness.
|
1 week after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in General Cognitive Function
Time Frame: Baseline, 1 week after the intervention
|
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) - Higher scores indicate a better outcome
|
Baseline, 1 week after the intervention
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Changes in Verbal Memory
Time Frame: Baseline, 1 week after the intervention
|
Measured by Word List I and II (WMS-III) - Higher scores indicate a better outcome
|
Baseline, 1 week after the intervention
|
Changes in Episodic Memory
Time Frame: Baseline, 1 week after the intervention
|
Measured by Logical Memory I and II (WMS-III) - Higher scores indicate a better outcome
|
Baseline, 1 week after the intervention
|
Changes in Sustained Attention
Time Frame: Baseline, 1 week after the intervention
|
Measured by Coding-Digit Symbol (WAIS-III) - Higher scores indicate a better outcome
|
Baseline, 1 week after the intervention
|
Changes in Depressive Symptomatology
Time Frame: Baseline, 1 week after the intervention
|
Measured by Geriatric Depression Scale-30 (GDS-30) - Lower scores indicate a better outcome
|
Baseline, 1 week after the intervention
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Changes in Anxious Symptomatology
Time Frame: Baseline, 1 week after the intervention
|
Measured by Geriatric Anxiety Inventory (GAI) - Lower scores indicate a better outcome
|
Baseline, 1 week after the intervention
|
Changes in Subjective Memory Complaints
Time Frame: Baseline, 1 week after the intervention
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Measured by Subjective Memory Complaints Scale (QSM) - Lower scores indicate a better outcome
|
Baseline, 1 week after the intervention
|
Changes in Quality of Life
Time Frame: Baseline, 1 week after the intervention
|
Measured by World Health Organization Quality of Life-OLD Module (WHOQOL-OLD) - Higher scores indicate a better outcome
|
Baseline, 1 week after the intervention
|
Changes in Functional Capacity
Time Frame: Baseline, 1 week after the intervention
|
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) - Lower scores indicate a better outcome
|
Baseline, 1 week after the intervention
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPPI-CINEICC
- SFRH/BD/146170/2019 (Other Grant/Funding Number: Foundation for Science and Technology (FCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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