Preventive InterventionNCT05637177
Preventive Intervention to Promote Healthy Ageing
A study testing Anging Wisely, Music therapy and Reminiscence therapy in people with Preventive Intervention, run by University of Ostrava at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventive Intervention
- What is being tested?
- Anging Wisely, Music therapy and Reminiscence therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 60 years
- living at home in Moravian-Silesian region
- consent with partici-pation in the study
- no dementia diagnosis.
Who cannot join
- dementia diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Support of Healthy Ageing: Using Educational and Psychosocial In-terventions to Maintain Mental Health, for Prevention and Timely Diagnosis of Depression, Anxiety, and Cognitive Disorders of Older Adults in a Community
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.
Read the detailed description
The main objective of the project is to determine the efficiency ofeducational pro-grams and psychosocial interventions to maintain mentalhealth, to prevent and timely diagnose any depression, anxieties, andcognitive disorders in older adults living in a community. Furthermore, theaim is to ascertain the incidence of depression, anxiety, and cognitivedisorders in these older adults and its correlation to the assessment of lifemeaningfulness, self-respect, attitudes to old age and ageing, and the levelof social support. An intervention study will be carried out. A preventionprogram will be for-mulated based on the individual needs of older adults asidentified in the focus groups. Selected interventions will be performed in apresent form (face to face) as well as distance form (e-Health) and will runat least for 6 months. The assessment of anxiety, depression, cognitivefunctions, and other psychosocial aspects will be done before theinterventions start, when they finish, and 3 months after that. Based on-quantitative analysis, there will be evaluated the efficiency of the providedinterven-tion with respect to depression, anxiety, cognitive function, andpsychosocial aspects (attitudes to old age, self-esteem, the sense ofcoherence, quality of life, level of social support). Older adults in thecentrum for prevention and support healthy ageing in the community will beincluded in the research sample. Based on the findings, recommen-dations will be formulated regarding the selected interventions used in communi-tycare.
- Conditions
- Preventive Intervention
- Being tested
- Anging Wisely, Music therapy, Reminiscence therapy, Cognitive training, Educational activities
- Keywords
- Mental health, quality of life, anxiety, depression, population ageing
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anging WiselyBehavioural
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.
Music therapyBehavioural
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.
Reminiscence therapyBehavioural
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.
Cognitive trainingBehavioural
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.
Educational activitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Educational activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preventive InterventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637177
- Sponsor's protocol ID
- NU21-09-00067
- Status last verified
- Feb 2025
- First submitted
- 24 Nov 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7183759Pachana 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.
PubMed 16805925Laidlaw 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.
PubMed 17051535Bowling 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.
PubMed 22999305Buzgova 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.
PubMed 37092730
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support of Healthy Ageing: Using Educational and Psychosocial In-terventions to Maintain Mental Health, for Prevention and Timely Diagnosis of Depression, Anxiety, and Cognitive Disorders of Older Adults in a Community
- ClinicalTrials.gov ID
- NCT05637177
- Acronym / sponsor ID
- NU21-09-00067
- Conditions
- Preventive Intervention
- Keywords
- Mental health, quality of life, anxiety, depression, population ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of OstravaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Dec 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 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.
Detailed description
The main objective of the project is to determine the efficiency ofeducational pro-grams and psychosocial interventions to maintain mentalhealth, to prevent and timely diagnose any depression, anxieties, andcognitive disorders in older adults living in a community. Furthermore, theaim is to ascertain the incidence of depression, anxiety, and cognitivedisorders in these older adults and its correlation to the assessment of lifemeaningfulness, self-respect, attitudes to old age and ageing, and the levelof social support. An intervention study will be carried out. A preventionprogram will be for-mulated based on the individual needs of older adults asidentified in the focus groups. Selected interventions will be performed in apresent form (face to face) as well as distance form (e-Health) and will runat least for 6 months. The assessment of anxiety, depression, cognitivefunctions, and other psychosocial aspects will be done before theinterventions start, when they finish, and 3 months after that. Based on-quantitative analysis, there will be evaluated the efficiency of the providedinterven-tion with respect to depression, anxiety, cognitive function, andpsychosocial aspects (attitudes to old age, self-esteem, the sense ofcoherence, quality of life, level of social support). Older adults in thecentrum for prevention and support healthy ageing in the community will beincluded in the research sample. Based on the findings, recommen-dations will be formulated regarding the selected interventions used in communi-tycare.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | Behavioral: Anging WiselyWe 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. |
| Reminiscence therapy | Experimental | Behavioral: Reminiscence therapyReminiscence 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. |
| Music therapy | Experimental | Behavioral: Music therapyThe 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. |
| memory training | Experimental | Behavioral: Cognitive trainingCognitive 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. |
| creation of educational modules (mental health, neural diseases …) | Experimental | Behavioral: Educational activitiesEducational 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 60 years
- living at home in Moravian-Silesian region
- consent with partici-pation in the study
- no dementia diagnosis.
Key exclusion criteria (1 listed)
- dementia diagnosis
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 |
|---|---|---|
| Anging WiselyThe 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. | Behavioural | Cognitive behavioral therapy (CBT) |
| Music therapyMusic 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. | Behavioural | Music therapy |
| Reminiscence therapyReminiscence 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. | Behavioural | Reminiscence therapy |
| Cognitive trainingIntervention "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. | Behavioural | memory training |
| Educational activitiesInterventions 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. | Behavioural | creation of educational modules (mental health, neural diseases …) |
Primary outcome
Assessment of depression: The Geriatric Depression Scale - GDS
Time frame: 12 weeks
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.
Assessment of anxiety: Geriatric Anxiety Inventory - GAI
Time frame: 12 weeks
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.
Assessment of cognitive functioning: Montreal Cognitive Assessment - MoCA
Time frame: 12 weeks
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.
Assessment of quality of life: OPQOL-CZ-20 (Older People's Quality of Life Questionnai-re).
Time frame: 12 weeks
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.
Assessment of the sense of coherence: The Sense of Coherence Scale - SOC-13
Time frame: 12 weeks
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.
Assessment of Life satisfaction: Life Satisfaction Index for the Third Age - Short Form - LSITA-SF
Time frame: 12 weeks
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.
Assessment of self-esteem: Rosenberg Self-Esteem Scale - RSES
Time frame: 12 weeks
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.
Assessment of attitudes to ageing: Attitudes to Ageing Questionnaire - AAQ
Time frame: 12 weeks
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.
Assessment of social support: Social Support Questionnaire - Short Form (SSQ6)
Time frame: 12 weeks
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.
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 25 Feb 2025.
- Background: PubMed 7183759Yesavage 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.
- Background: PubMed 16805925Pachana 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.
- Background: PubMed 17051535Laidlaw 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.
- Background: PubMed 22999305Bowling 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.
- Derived from this study: PubMed 37092730Buzgova 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.
- Antonovsky, A. Unravelling the mystery of health. How people manage stress and stay well. New York: Jossey Bass Publisher; 1987. 1st ed. 218 pp. ISBN 9781555420284Link provided by the sponsor.
- 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 Anging Wisely, Music therapy and Reminiscence therapy in people with Preventive Intervention, run by University of Ostrava at 1 site in Czechia.
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 4 inclusion and 1 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 25 Feb 2025. 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 Czechia. 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?
Assessment of depression: The Geriatric Depression Scale - GDS (time frame: 12 weeks). The study lists 9 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 NCT05637177, which also lists 5 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 25 Feb 2025.