Homebound Elderly People Psychotherapeutic Intervention

NCT04967378 | Completed

• 2 other identifiers: HEPPI-CINEICCSFRH/BD/146170/2019
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Depressive Symptoms; Anxiety State

Keywords

Homebound Older Adults; Mild Cognitive Impairment; Depressive and Anxious Symptomatology; Cognitive-Emotional Intervention Program

Outcome Measures

Primary Outcomes (3)

• Feasibility of HEPPI program

  Measured by recruitment rate

  Baseline

• Feasibility of HEPPI program

  Measured by drop-out rate

  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.

  1 week after the intervention

Secondary Outcomes (9)

• Changes in General Cognitive Function

  Baseline, 1 week after the intervention

• Changes in Verbal Memory

  Baseline, 1 week after the intervention

• Changes in Episodic Memory

  Baseline, 1 week after the intervention

• Changes in Sustained Attention

  Baseline, 1 week after the intervention

• Changes in Depressive Symptomatology

  Baseline, 1 week after the intervention

Study Arms (2)

HEPPI program

EXPERIMENTAL

Behavioral: HEPPI

Waiting-list control group

NO INTERVENTION

Receives access to HEPPI program at the end of the study.

Interventions

HEPPI BEHAVIORAL

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.

Also known as: Homebound Elderly People Psychotherapeutic Intervention

HEPPI program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)

Coimbra, 3000, Portugal

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Integrated non-PhD member

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: July 19, 2021
• Study Start: June 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)