NCT05637177

Brief Summary

The aim of the project is the support of healthy ageing of older adults in acommunity. Efficient educational and psychosocial intervention will besuggested and verified to prevent anxiety, depression, and cognitivedisorders of selected older adults, to im-prove their self-esteem,meaningfulness of life, sense of coherence, quality of life, and attitudes toold age. Correlations among anxiety, depression, cognitive functions, andcertain psychosocial aspects will be analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

November 24, 2022

Last Update Submit

February 23, 2025

Conditions

Keywords

Mental healthquality of lifeanxietydepressionpopulation ageing

Outcome Measures

Primary Outcomes (9)

  • Assessment of depression: The Geriatric Depression Scale - GDS

    The Geriatric Depression Scale may be used with healthy, medically ill, and mild to moderately cognitively impaired older adults. It has been extensively used incommunity, acute care, and long-term care settings. A Short Form GDS consisting of 15 questions was developed in 1986. The total score of the Geriatric Depression Scale can ranged from 0 to 15 points, and higher score indicates more depression symptoms. Scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and12-15 indicate severe depression.

    12 weeks

  • Assessment of anxiety: Geriatric Anxiety Inventory - GAI

    The Geriatric Anxiety Inventory Scale consists of 20 "Agree/Disagree" items designed to assess the typical common anxiety symptoms. The total score of the Geriatric Anxiety Inventory Scale can ranged from 0 to 20 points, and higher score indicates more anxiety.

    12 weeks

  • Assessment of cognitive functioning: Montreal Cognitive Assessment - MoCA

    The MoCA evaluates different types of cognitive abilities. Theseinclude - orientation, short-term memory, executivefunction/visuospatial ability (language abilities, abstraction, animalnaming, attention), clock-drawing test. Scores on the Montreal Cognitive Assessment range from 0 to 30, with a score of 26 and higher generally considered normal. The scoring breakdown is as follows: visuospatial and executivefunctioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), orientation (6 points), Test MoCA makes it possible to identify sooner the early cognitive disorders, because it evaluates one's memory in detail and analyzes the executive functions.

    12 weeks

  • Assessment of quality of life: OPQOL-CZ-20 (Older People's Quality of Life Questionnai-re).

    The Older People's Quality of Life Questionnaire (OPQoL-brief) consisted of 13 statements, with the participants being asked to indicate the extent to which they agree with each statement by selecting one of five possible options ("strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree"). The range in the original version is based on the principle of point allocation (1-5). The items are summed to provide a total OPQoL-brief score. The total score of Older People's Quality of Life Questionnaire ranges from 13 to 65 and higher scores indicate better quality of life. The OPQoL-brief questionnaire also includes a preliminary single item on global quality of life. This single item is not scored with the OPQOL, it is coded as very good to very bad.

    12 weeks

  • Assessment of the sense of coherence: The Sense of Coherence Scale - SOC-13

    The short form of the Sense of Coherence Scale -SOC-13 scale consists of 13 items that comprise three components: comprehensibility (to which 5 items contribute), manageability (4 items), and meaningfulness (4 items). The respondents indicate agreement or disagreement on a 7-category semantic differential scale with two anchoring responses tailored to the content of each item. The total score of the Sense of Coherence Scale can range from 13 to 91, and a higher score indicates higher sense of coherence.

    12 weeks

  • Assessment of Life satisfaction: Life Satisfaction Index for the Third Age - Short Form - LSITA-SF

    The Life Satisfaction Index for the Thirds Age - Short form questionnaire contains 12 items with options on the 6-point Likert scale: Strongly Disagree (6), Disagree (5), Somewhat Disagree (4), Somewhat Agree (4), Agree (2), and Strongly Agree (1). The total scores of the The Life Satisfaction Index for the Thirds Age - Short form questionnaire range from 12 to 72. Higher scores mean lower life satisfaction.

    12 weeks

  • Assessment of self-esteem: Rosenberg Self-Esteem Scale - RSES

    Rosenberg Self-Esteem Scale - RSES is a 10-item Likert type scale, with items answered on a four-point scale: from Strongly Agree (SA) toStrongly Disagree (SD). The total scores of the Rosenberg Self-Esteem Scale rank from 0 to 25 points. Score from 15 to 25 shows normal self-esteem and score of less than 15 shows low self-esteem. TheRosenberg Self-Esteem Scale, a widely used self-report instrument forevaluating individual self-esteem, was investigated using itemresponse theory.

    12 weeks

  • Assessment of attitudes to ageing: Attitudes to Ageing Questionnaire - AAQ

    The 24 items of the Attitudes to Ageing Questionnaire scale are scored on a five-point Likert scale (1 = strongly disagree, 5 = strongly agree). It consists of three broaddimensions of ageing: 1. physical functioning (8 items including health,dynamics, vitality, exercising), 2. psychological growth (8 items, whichreflect explicit gains in relation to self and others; the positive focus ofageing, life orientation, connection with "wisdom" and "fruits of life",coping, acceptance, communication with young generation), 3.psychosocial losses (8 items, when old age is primarily described as anegative experience including losses, deficiency, exclusion, loss ofindependence, depression, and loneliness). Each factor has eight questions with domains returning minimum scores of 8 and maximum of 40. Higher score indicates better attitudes to ageing.

    12 weeks

  • Assessment of social support: Social Support Questionnaire - Short Form (SSQ6)

    This instrument has 6 items that measure perceived social support. Foreach of the 6 items, respondents indicate the number of peopleavailable to provide support in each of 6 areas and then rate theoverall level of satisfaction with the support given in each of the areas. The total scores of the Social support Questionnaire rank from 0 to 6 points. Higher score indicates more social support.

    12 weeks

Study Arms (5)

Cognitive behavioral therapy (CBT)

EXPERIMENTAL

We used the "Aging Wisely" program for seniors living in the community, which uses elements of CBT and is specifically designed for older people over the age of 65 living in the community who may be in a worried, anxious or depressed mood. The program focuses on psychoeducation to manage these feelings. Seniors learn to change the ways they think and behave that maintain depression and anxiety. The sessions include education on the process of aging, coping with loneliness, improving sleep, coping with worry and avoidance, coping with loss and death. During the sessions, participants learn to track mood, motivation to change, goal setting, planning pleasant activities, identifying thoughts, working with useless thoughts, and practice techniques to replace useless thoughts. The last two sessions are dedicated to assertiveness and communication, and preventing recurrence of problems.

Behavioral: Anging Wisely

Reminiscence therapy

EXPERIMENTAL

Reminiscence is a method of working with memories. Remembering has an irreplaceable place in every person's life. It is a natural activity that can encourage people, make them aware of their own achievements, different moments in life, point out their value, promote self-esteem and contribute to the development of relationships. Self-remembering is a natural form of cognitive stimulation.

Behavioral: Reminiscence therapy

Music therapy

EXPERIMENTAL

The aim of music therapy is to optimize the quality of life, and to improve psychological, social, communication, emotional and mental health and well-being. Music therapy brings psychological and physical relaxation, reduces stress, improves mood, alleviates anxiety, improves memory and attention, develops and facilitates communication, enables self-expression. For this purpose, a number of activities are used, such as listening to music, singing, playing simple rhythmic instruments, playing the body and a number of other activities that will be carried out with seniors as part of the intervention.

Behavioral: Music therapy

memory training

EXPERIMENTAL

Cognitive training is targeted and structured exercise of cognitive functions (learning, memory, attention, speech, visual-spatial functions, ability to solve problems, plan or manage various tasks and correctly recognize one's surroundings). Regular exercise of cognitive abilities can create a cognitive reserve that can delay the potential aggravation of problems in memory or attention and improve quality of life. The content of the intervention will be activities developing cognitive functions (primarily memory, attention, imagination, spatial orientation and decision-making speed), practical training and motivation for long-term regular strengthening of cognitive functions using the comprehensive training program MENTEM.

Behavioral: Cognitive training

creation of educational modules (mental health, neural diseases …)

EXPERIMENTAL

Educational activities will focus on disease prevention in three main directions - cardiovascular diseases, mental health and neurological diseases. Educational activities will take place within the University of the Third Age LF OU.

Behavioral: Educational activities

Interventions

Anging WiselyBEHAVIORAL

The program includes 11 meetings of two hours in a group of up to eight people. The sessions are held weekly. Each lesson is given a homework assignment. A total of 10 groups will take place.

Cognitive behavioral therapy (CBT)
Music therapyBEHAVIORAL

Music therapy sessions are held once a week for 60 minutes for 12 weeks. The maximum number of participants per group is 12. A total of 10 groups will be implemented.

Music therapy

Reminiscence therapy sessions are held once a week for 60 minutes for 12 weeks. The maximum number of participants per group is 10. A total of 5 groups will be implemented.

Reminiscence therapy

Intervention "cognitive training" will take place once a week for 45 minutes for 20 weeks. Seniors can choose from two options: 1. group training full-time or home training (online) using the comprehensive training program MENTEM.

memory training

Interventions in educational activities will run for one academic year. In total, seniors will attend 16 lectures in each educational module. The lectures will run 1 x 14 days for 90 minutes.

creation of educational modules (mental health, neural diseases …)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 60 years
  • living at home in Moravian-Silesian region
  • consent with partici-pation in the study
  • no dementia diagnosis.

You may not qualify if:

  • dementia diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ostrava

Ostrava, Česká Republika, 70300, Czechia

Location

Related Publications (5)

  • Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

    PMID: 7183759BACKGROUND
  • Pachana NA, Byrne GJ, Siddle H, Koloski N, Harley E, Arnold E. Development and validation of the Geriatric Anxiety Inventory. Int Psychogeriatr. 2007 Feb;19(1):103-14. doi: 10.1017/S1041610206003504.

    PMID: 16805925BACKGROUND
  • Laidlaw K, Power MJ, Schmidt S; WHOQOL-OLD Group. The Attitudes to Ageing Questionnaire (AAQ): development and psychometric properties. Int J Geriatr Psychiatry. 2007 Apr;22(4):367-79. doi: 10.1002/gps.1683.

    PMID: 17051535BACKGROUND
  • Bowling A, Hankins M, Windle G, Bilotta C, Grant R. A short measure of quality of life in older age: the performance of the brief Older People's Quality of Life questionnaire (OPQOL-brief). Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):181-7. doi: 10.1016/j.archger.2012.08.012. Epub 2012 Sep 19.

    PMID: 22999305BACKGROUND
  • Buzgova R, Bobcikova K, Kozakova R, Zelenikova R. The Czech version of the life satisfaction index for the third age-short form (LSITA-SF12): Psychometric properties. Int J Older People Nurs. 2023 Jul;18(4):e12541. doi: 10.1111/opn.12541. Epub 2023 Apr 24.

Related Links

MeSH Terms

Conditions

Psychological Well-BeingAnxiety DisordersDepression

Interventions

Music TherapyCognitive Training

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesNeurological RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 5, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations