Mild Cognitive ImpairmentHEPPINCT04967378
Homebound Elderly People Psychotherapeutic Intervention
A study testing HEPPI in people with Mild Cognitive Impairment and Depressive Symptoms, run by University of Coimbra at 1 site in Portugal.
Trial summary
This study aims to develop, implement, and assess the feasibility, acceptability, and preliminary efficacy of a 10-week structured and individualized cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment (MCI) and with depressive and/or anxiety symptoms. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Depressive Symptoms, Anxiety State
- What is being tested?
- HEPPI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Coimbra, 3000
About this study
Official title: Feasibility, Acceptability, and Preliminary Efficacy Study of a Cognitive-Emotional Intervention Program for Homebound Older Adults With Mild Cognitive Impairment
This study aims to develop, implement, and assess the feasibility, acceptability, and preliminary efficacy of a 10-week structured and individualized cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment (MCI) and with depressive and/or anxiety symptoms. Homebound Elderly People Psychotherapeutic Intervention (HEPPI) is designed to maintain or improve memory functioning, reduce depressive and/or anxiety symptoms, and help participants to compensate or adapt to impaired cognitive performance, improving their quality of life and their subjective perception of memory and health.
Read the 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.
- Being tested
- HEPPI
- Keywords
- Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention Program
- Medical subject headings
- Cognitive Dysfunction, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPPIBehavioural
Also called Homebound Elderly People Psychotherapeutic Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| HEPPI program | Experimental | Not described Receives: Behavioral: HEPPI |
| Waiting-list control group | No intervention | Receives access to HEPPI program at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of HEPPI program
Measured by recruitment rate
Measured: Baseline
Feasibility of HEPPI program
Measured by drop-out rate
Measured: Immediately after the intervention
Acceptability of HEPPI program
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.
Measured: 1 week after the intervention
Secondary outcomes (9)
Changes in General Cognitive Function
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) - Higher scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Verbal Memory
Measured by Word List I and II (WMS-III) - Higher scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Episodic Memory
Measured by Logical Memory I and II (WMS-III) - Higher scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Sustained Attention
Measured by Coding-Digit Symbol (WAIS-III) - Higher scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Depressive Symptomatology
Measured by Geriatric Depression Scale-30 (GDS-30) - Lower scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Anxious Symptomatology
Measured by Geriatric Anxiety Inventory (GAI) - Lower scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Subjective Memory Complaints
Measured by Subjective Memory Complaints Scale (QSM) - Lower scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Quality of Life
Measured by World Health Organization Quality of Life-OLD Module (WHOQOL-OLD) - Higher scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Changes in Functional Capacity
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) - Lower scores indicate a better outcome
Measured: Baseline, 1 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jun 2020
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Andreia Jesus, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967378
- Sponsor's protocol ID
- HEPPI-CINEICC
- Other IDs
- SFRH/BD/146170/2019
- Acronym
- HEPPI
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy Study of a Cognitive-Emotional Intervention Program for Homebound Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04967378
- Acronym / sponsor ID
- HEPPI / HEPPI-CINEICC
- Keywords
- Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop, implement, and assess the feasibility, acceptability, and preliminary efficacy of a 10-week structured and individualized cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment (MCI) and with depressive and/or anxiety symptoms. Homebound Elderly People Psychotherapeutic Intervention (HEPPI) is designed to maintain or improve memory functioning, reduce depressive and/or anxiety symptoms, and help participants to compensate or adapt to impaired cognitive performance, improving their quality of life and their subjective perception of memory and health.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEPPI program | Experimental | Behavioral: HEPPI |
| Waiting-list control group | No intervention | –Receives access to HEPPI program at the end of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPPIAlso: Homebound Elderly People Psychotherapeutic Intervention10 weekly individual sessions, 90 minutes each, at the participants' homes. The content of sessions includes psychoeducation, cognitive training, psychotherapeutic intervention, and compensatory strategy training. | Behavioural | HEPPI program |
Primary outcome
Feasibility of HEPPI program
Time frame: Baseline
Measured by recruitment rate
Feasibility of HEPPI program
Time frame: Immediately after the intervention
Measured by drop-out rate
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.
9 secondary outcomes
Changes in General Cognitive Function
Time frame: Baseline, 1 week after the intervention
Changes in Verbal Memory
Time frame: Baseline, 1 week after the intervention
Changes in Episodic Memory
Time frame: Baseline, 1 week after the intervention
Changes in Sustained Attention
Time frame: Baseline, 1 week after the intervention
Changes in Depressive Symptomatology
Time frame: Baseline, 1 week after the intervention
Changes in Anxious Symptomatology
Time frame: Baseline, 1 week after the intervention
Changes in Subjective Memory Complaints
Time frame: Baseline, 1 week after the intervention
Changes in Quality of Life
Time frame: Baseline, 1 week after the intervention
Changes in Functional Capacity
Time frame: Baseline, 1 week after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEPPI in people with Mild Cognitive Impairment and Depressive Symptoms, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of HEPPI program (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.