Clinical trial NCT05499767: HEPPI: Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
Official title: HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Depressive Symptoms
Anxiety State
Keywords: Homebound Older Adults
Mild Cognitive Impairment
Depressive and Anxious Symptomatology
Cognitive-Emotional Intervention
Randomized Controlled Trial
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2022-08-12
Enrollment: 199
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Episodic Memory
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Depressive Symptomatology
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Anxious Symptomatology
timeFrame: Baseline, post-intervention, and 3-month follow-up
Secondary outcomes:
measure: Changes in General Cognitive Function
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Attentional Control
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Subjective Memory Complaints
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Perceived Quality of Life
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Functional Status
timeFrame: Baseline, post-intervention, and 3-month follow-up
measure: Changes in Loneliness
timeFrame: Baseline, post-intervention, and 3-month follow-up
Other outcomes:
measure: Personality Traits
timeFrame: Baseline
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Study officials:
References: