Mild Cognitive ImpairmentHEPPINCT05499767
HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
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
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. 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
- 199 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2021to 31 Mar 2023
- 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 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Coimbra
About this study
Official title: HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
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.
Read the detailed description
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.
- Being tested
- HEPPI
- Keywords
- Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention, Randomized Controlled Trial
- 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
Homebound Elderly People Psychotherapeutic Intervention
| Study group | Role | What they receive |
|---|---|---|
| HEPPI | Experimental | The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes. Receives: Behavioral: HEPPI |
| Treatment as Usual (TAU) | No intervention | The TAU group receives access to HEPPI at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Episodic Memory
Logical Memory of the Wechsler Memory Scale-III (LM) | Higher scores indicate a better outcome
Measured: 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
Measured: Baseline, post-intervention, and 3-month follow-up
Changes in Anxious Symptomatology
Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome
Measured: Baseline, post-intervention, and 3-month follow-up
Secondary outcomes (6)
Changes in General Cognitive Function
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) | Higher scores indicate a better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, post-intervention, and 3-month follow-up
Changes in Loneliness
Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome
Measured: Baseline, post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2021
- Primary completion30 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 199 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
- NCT05499767
- Sponsor's protocol ID
- HEPPIEfficacy/CINEICC
- Other IDs
- SFRH/BD/146170/2019
- Acronym
- HEPPI
- Status last verified
- May 2023
- First submitted
- 9 Aug 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jesus AG, de Lima MP, Vilar M, Pachana NA. Homebound elderly people psychotherapeutic intervention (HEPPI): Exploring the mediating role of loneliness. Arch Gerontol Geriatr. 2024 Mar;118:105308. doi: 10.1016/j.archger.2023.105308. Epub 2023 Dec 3.
PubMed 38101250Jesus AG, Lima MP, Vilar M, Pachana NA. HEPPI: a randomized controlled trial of the efficacy of a cognitive-emotional intervention for homebound older adults. Aging Ment Health. 2024 Mar-Apr;28(3):491-501. doi: 10.1080/13607863.2023.2260760. Epub 2023 Sep 25.
PubMed 37747057
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
- ClinicalTrials.gov ID
- NCT05499767
- Acronym / sponsor ID
- HEPPI / HEPPIEfficacy/CINEICC
- Keywords
- Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Aug 2022 (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.
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.
Detailed description
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.
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 | Experimental | Behavioral: HEPPIThe HEPPI group attends weekly 90-minute intervention sessions at the participants' homes. |
| Treatment as Usual (TAU) | No intervention | –The TAU group receives access to HEPPI 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 (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| HEPPIHomebound Elderly People Psychotherapeutic Intervention | Behavioural | HEPPI |
Primary outcome
Changes in Episodic Memory
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
Changes in Depressive Symptomatology
Time frame: Baseline, post-intervention, and 3-month follow-up
Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome
Changes in Anxious Symptomatology
Time frame: Baseline, post-intervention, and 3-month follow-up
Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome
6 secondary outcomes
Changes in General Cognitive Function
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Attentional Control
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Subjective Memory Complaints
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Perceived Quality of Life
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Functional Status
Time frame: Baseline, post-intervention, and 3-month follow-up
Changes in Loneliness
Time frame: Baseline, post-intervention, and 3-month follow-up
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 9 May 2023.
- Derived from this study: PubMed 38101250Jesus AG, de Lima MP, Vilar M, Pachana NA. Homebound elderly people psychotherapeutic intervention (HEPPI): Exploring the mediating role of loneliness. Arch Gerontol Geriatr. 2024 Mar;118:105308. doi: 10.1016/j.archger.2023.105308. Epub 2023 Dec 3.
- Derived from this study: PubMed 37747057Jesus AG, Lima MP, Vilar M, Pachana NA. HEPPI: a randomized controlled trial of the efficacy of a cognitive-emotional intervention for homebound older adults. Aging Ment Health. 2024 Mar-Apr;28(3):491-501. doi: 10.1080/13607863.2023.2260760. Epub 2023 Sep 25.
- Individual participant dataSharing planned: No
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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 8 inclusion and 6 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 9 May 2023. 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?
Changes in Episodic Memory (time frame: Baseline, post-intervention, and 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT05499767, which also lists 2 linked publications.
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 9 May 2023.