An observational study in Health, Subjective, Disability, Evaluation and Chronic Disease, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Observational
Gabarrell-Pascuet A, Varga TV, Moneta MV, Ayuso-Mateos JL, Lara E, Olaya B, Haro JM, Domenech-Abella J. What factors explain the changes in major depressive di…PubMed 36806591 ↗; 21 more. 1 publication citing this study linked from PubMed
Ageing with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. The data that makes up the baseline was collected from a nationally representative sample of non-institutionalized adults as part of the "Collaborative Research on Aging in Europe (COURAGE in Europe)" project between July 2011 and May 2012. The second wave was carried out as part of the "Age with Health" project between December 2014 and June 2015, and three years later, in 2018, the third wave was carried out. In 2019-2021, a new cohort of participants were brought in (2019 cohort), some of whom were interviewed again by telephone during the first Coronavirus (COVID-19) lockdown, in early 2020. In 2022, the fourth wave of the 2011 cohort was evaluated, and in 2023, the second wave of the 2019 cohort was evaluated. Finally, in 2025, the fifth wave of the 2011 cohort and the third wave of the 2019 cohort were evaluated, which are the last follow-ups in this study.
Study Design:
A prospective cohort general population study.
Sample:
Wave 1: A nationally representative sample of non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed; four strata based on the number of inhabitants of the municipalities were built for each of the 17 Spanish autonomous communities. Clusters were selected within the strata with a probability of inclusion relative to their size. Within each cluster, households were randomly selected from a list of all households. In case there was more than one individual from the corresponding age group in the household, a random method was employed to select the individual participant.
Wave 2: Wave 1 sample was re-interviewed (Wave 2) in 2014-2015.
Wave 3: in 2018, participants were again evaluated. Complementarily, between 2019 and 2021 a new sample from the regions of Madrid and Barcelona were brought in, and it was interviewed again by telephone during the first COVID-19 lockdown, in May-June 2020.
Wave 4: a new evaluation of the participants of both cohorts 2011 and 2019 was carried out, in the fist case it terminated in 2022, while the data collection for 2019 cohort terminated in 2023.
Wave 5: the last follow-up of both cohorts was carried out in 2025.
Data collection:
Face-to-face interviews by Computer-Assisted Personal Interviewing at the respondents' homes by trained interviewers. All interviewers received a standardized training. Data quality control was also performed. A proxy interview was administered in those cases in which the participant presents physical or cognitive limitations that may impede the correct administration of the individual interview.
Main project objectives:
To assess trajectories of general health, disability and well-being in Spanish ageing population.
Secondary objectives:
To identify trajectories of healthy ageing (in terms of physical health, mental health, functioning and well-being) in Spanish adult population as well as their determinants To analyse prevalence and impact of chronic health conditions, mental health problems, well-being and loneliness on mortality in Spanish adult population.
To determine risk factors for incidence and persistence of mental and physical health problems in Spanish ageing population.
Main project hypotheses:
The trajectories of health, functioning and well-being will be encompassed by relevant environmental factors such as social support, loneliness and health care utilization, personal factors (socio-demographic characteristics, healthy lifestyles, and high cognitive reserve among others) and other biological and health-related factors (weight, height, waist circumference, executive functions, blood pressure, grip strength, vision acuity, presence of mental and physical health problems and quality of life).
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's enrollment of 7,755 is above the median of 220 across 389 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
Compared within Mental Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Community-living individuals in Spain aged 18 years or older
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A nationally representative sample of 4753 non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed. A total of 2528 individuals were re-interviewed in 2014. In 2018, 1577 were again evaluated. In 2022, 963 participants took part of another study's evaluation. The last follow-up of this cohort was conducted in 2025, when 595 participants were evaluated.
3002 participants from the regions of Madrid and Barcelona were brought in between 2019 and 2021. The second wave of this cohort was conducted in 2023, and 1,116 participants were evaluated. This cohort was last evaluated in 2025, with 844 participants. In 2020, during the first Coronavirus (COVID-19) lockdown, 1166 of the participants from the first wave of the cohort were telephonically interviewed, a lateral sub-study evaluation.
Heath Status
Measure: Health composite total score. Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.
Time frame: Baseline
Disability
Measure: World Health Organization's Disability Assessment Schedule-II (WHODAS-II). Construct: Disability. Final result: A global total score. Range: 0-100. 0 means lower disability
Time frame: Baseline
Experienced Well-being
Abbreviated Version of the Day Reconstruction Method. Construct: Experienced wellbeing. Final Result: The used scale reports two global scores: * Positive Affect total score. Range: 0-100 where 0 means lower positive affect. * Negative Affect total score. Range 0-100 where 0 means lower negative affect.
Time frame: Baseline
Quality of Life (WHOQOL-AGE)
Measure: World Health Organization Quality of Life-Age (WHOQOL-AGE) (Caballero, et al., 2013). Construct: Quality of life. Final Result: A global total score. Range 0-100. 0 means lower quality of life
Time frame: Baseline
Number of Participants With Depression
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Depression module (WHO-CIDI, 1990). Construct: Presence of Depression. Final result: Two measures of depression according to Research Diagnostic Criteria. * Presence of 12 month depression. Values (yes/no). * Presence of lifetime depression. Values (yes/no).
Time frame: Baseline
Presence of Suicide Behavior
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Suicide module (WHO-CIDI, 1990). Construct: Presence of Suicide behavior The instrument reports six measures of suicide behavior. * Presence of 12 month suicide ideation. Values (yes/no) * Presence of 12 month suicide planning. Values (yes/no) * Presence of 12 month suicide attempts. Values (yes/no) * Presence of lifetime suicide ideation. Values (yes/no) * Presence of lifetime suicide planning. Values (yes/no) * Presence of lifetime suicide attempts. Values (yes/no)
Time frame: Baseline
Presence of Anxiety Disorders
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Anxiety disorders module (WHO-CIDI, 1990). Construct: Presence of anxiety Disorders Final Result: The instrument included in the study reports six measures of anxiety disorders according to Research diagnostic criteria. * Presence of 12 month panic disorder. Values (yes/no) * Presence of 12 month generalized anxiety disorder. Values (yes/no) * Presence of 12 month phobic disorder. Values (yes/no) * Presence of lifetime panic disorder. Values (yes/no) * Presence of lifetime generalized anxiety disorder. Values (yes/no) * Presence of lifetime phobic disorder. Values (yes/no)
Time frame: Baseline
Presence of Diabetes
Construct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)
Time frame: Baseline
Presence of Lung Disease
Construct: Presence of any lung disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any lung disease Values: (Yes/No)
Time frame: Baseline
Presence of Stroke
Construct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)
Time frame: Baseline
Alcohol Use Information
Construct: Alcohol use Measure: Self-reported information of how many standard drinks per day in last 7 days have been used. Values: four categories of alcohol use: 0= Lifetime abstainers: Participants that have never used alcohol 1. Occasional drinkers: Participants that have ever used alcohol but not in the previous 7 days 2. Non-heavy drinker: Participants did consume alcohol in the last 30 days and in the last 7 days 3. Infrequent heavy drinker: Participants did consume alcohol 1-2 days per week, with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women. 4. Frequent heavy drinkers: Participants did consume alcohol 3 or more days per week with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women.
Time frame: Baseline
Tobacco Use Information
Construct: Tobacco use Measure: Self-reported information of how many cigarettes/pipes/tobacco products/ have been used in the last week. Values: Four categories of tobacco use: 0= Never smokers: Participants who have never used tobacco 1. Daily smokers: Participants who have used tobacco last week 2. Non daily smokers: Participants who have ever used tobacco but not in the previous week 3. Former smokers: Participants who smoked in the past (ex smokers)
Time frame: Baseline
Level of Physical Activity
Construct: Level of physical activity Scale: Global Physical Activity Questionnaire version 2 (GPAQ v2); It collects information on physical activity participation in three settings (or domains) and sedentary behavior. The responses given by the participants have been converted to Metabolic Equivalent to Task (MET) values. Applying MET values to activity levels allows for calculating total physical activities. Values: Three values of physical activity can be obtained 3=High physical activity 2=Moderate physical activity 1=Low physical activity
Time frame: Baseline
Level of Social Support
Construct: Social Support Measure: 3-Item Oslo Social Support Scale (OSLO) (Abiola et al., 2013) Result: A global total score, then transformed into a percentile scale. Range: 0-100. Higher scores indicate a higher social support.
Time frame: Baseline
Loneliness
Construct: Loneliness Measure: Three-item University of California, Los Angeles (UCLA) Loneliness Scale (Hughes et al, 2004) Result: A total loneliness score, then transformed into a percentile scale. Range: 0-100. Higher scores means higher loneliness
Time frame: Baseline
Spanish general adult population non-institutionalized; aged 18+ years with oversampling of those aged 50+ years and those 80+ years); multi-stage stratified sampling; representative sample.
| Milestone | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Started | 4753 | 3002 |
| Second wave | 2528 | 1037 |
| Third wave | 1577 | 844 |
| Fourth wave | 963 | 0 |
| Fifth wave | 595 | 0 |
| Completed | 595 | 844 |
| Not completed | 4158 | 2158 |
Measure: Health composite total score. Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.
| score on a scale | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Heath Status | 66.55 ± 13.11 | 68.95 ± 19.87 |
Measure: World Health Organization's Disability Assessment Schedule-II (WHODAS-II). Construct: Disability. Final result: A global total score. Range: 0-100. 0 means lower disability
| score on a scale | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics |
|---|---|---|
| Disability | 11.17 ± 17.59 | 9.01 ± 18.20 |
Abbreviated Version of the Day Reconstruction Method. Construct: Experienced wellbeing. Final Result: The used scale reports two global scores: * Positive Affect total score. Range: 0-100 where 0 means lower positive affect. * Negative Affect total score. Range 0-100 where 0 means lower negative affect.
| score on a scale | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Positive Affect | 4.88 ± 1.11 | 4.75 ± 1.59 |
| Negative Affect | 0.64 ± 0.89 | 0.33 ± 0.61 |
Measure: World Health Organization Quality of Life-Age (WHOQOL-AGE) (Caballero, et al., 2013). Construct: Quality of life. Final Result: A global total score. Range 0-100. 0 means lower quality of life
| score on a scale | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Quality of Life (WHOQOL-AGE) | 72.30 ± 14.90 | 76.17 ± 15.25 |
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Depression module (WHO-CIDI, 1990). Construct: Presence of Depression. Final result: Two measures of depression according to Research Diagnostic Criteria. * Presence of 12 month depression. Values (yes/no). * Presence of lifetime depression. Values (yes/no).
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Number of Participants With Depression | 510 | 203 |
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Suicide module (WHO-CIDI, 1990). Construct: Presence of Suicide behavior The instrument reports six measures of suicide behavior. * Presence of 12 month suicide ideation. Values (yes/no) * Presence of 12 month suicide planning. Values (yes/no) * Presence of 12 month suicide attempts. Values (yes/no) * Presence of lifetime suicide ideation. Values (yes/no) * Presence of lifetime suicide planning. Values (yes/no) * Presence of lifetime suicide attempts. Values (yes/no)
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Presence of Suicide Behavior | 161 | 75 |
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Anxiety disorders module (WHO-CIDI, 1990). Construct: Presence of anxiety Disorders Final Result: The instrument included in the study reports six measures of anxiety disorders according to Research diagnostic criteria. * Presence of 12 month panic disorder. Values (yes/no) * Presence of 12 month generalized anxiety disorder. Values (yes/no) * Presence of 12 month phobic disorder. Values (yes/no) * Presence of lifetime panic disorder. Values (yes/no) * Presence of lifetime generalized anxiety disorder. Values (yes/no) * Presence of lifetime phobic disorder. Values (yes/no)
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Presence of Anxiety Disorders | 69 | 77 |
Construct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Presence of Diabetes | 661 | 353 |
Construct: Presence of any lung disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any lung disease Values: (Yes/No)
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Presence of Lung Disease | 399 | 152 |
Construct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Presence of Stroke | 183 | 82 |
Construct: Alcohol use Measure: Self-reported information of how many standard drinks per day in last 7 days have been used. Values: four categories of alcohol use: 0= Lifetime abstainers: Participants that have never used alcohol 1. Occasional drinkers: Participants that have ever used alcohol but not in the previous 7 days 2. Non-heavy drinker: Participants did consume alcohol in the last 30 days and in the last 7 days 3. Infrequent heavy drinker: Participants did consume alcohol 1-2 days per week, with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women. 4. Frequent heavy drinkers: Participants did consume alcohol 3 or more days per week with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women.
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Lifetime abstainers | 1345 | 871 |
| Occasional drinkers | 1424 | 1055 |
| Non-heavy drinker | 1671 | 846 |
| Infrequent heavy drinker | 111 | 95 |
| Frequent heavy drinker | 32 | 38 |
| Missing | 0 | 6 |
Construct: Tobacco use Measure: Self-reported information of how many cigarettes/pipes/tobacco products/ have been used in the last week. Values: Four categories of tobacco use: 0= Never smokers: Participants who have never used tobacco 1. Daily smokers: Participants who have used tobacco last week 2. Non daily smokers: Participants who have ever used tobacco but not in the previous week 3. Former smokers: Participants who smoked in the past (ex smokers)
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Never smokers | 2339 | 1543 |
| Daily smokers | 1049 | 626 |
| Non daily smokers | 100 | 52 |
| Former smokers | 1095 | 690 |
Construct: Level of physical activity Scale: Global Physical Activity Questionnaire version 2 (GPAQ v2); It collects information on physical activity participation in three settings (or domains) and sedentary behavior. The responses given by the participants have been converted to Metabolic Equivalent to Task (MET) values. Applying MET values to activity levels allows for calculating total physical activities. Values: Three values of physical activity can be obtained 3=High physical activity 2=Moderate physical activity 1=Low physical activity
| Participants | Cohort 2011 | Cohort 2019 |
|---|---|---|
| High | 1464 | 898 |
| Moderate | 1724 | 1013 |
| Low | 1395 | 991 |
Construct: Social Support Measure: 3-Item Oslo Social Support Scale (OSLO) (Abiola et al., 2013) Result: A global total score, then transformed into a percentile scale. Range: 0-100. Higher scores indicate a higher social support.
| score on a scale | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Level of Social Support | 77.50 ± 16.73 | 77.44 ± 17.70 |
Construct: Loneliness Measure: Three-item University of California, Los Angeles (UCLA) Loneliness Scale (Hughes et al, 2004) Result: A total loneliness score, then transformed into a percentile scale. Range: 0-100. Higher scores means higher loneliness
| score on a scale | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Loneliness | 12.34 ± 24.25 | 10.74 ± 22.82 |
Collected over For both cohorts (2011 and 2019), data on adverse events and deaths are collected at the same time, when a new wave is carried out. Specifically for cohort 2011 adverse events have been evaluated 4 times during 12 years (2011-2012, 2014-2015, 2019-2021 and 2022-2023) and for cohort 2019 they have been evaluated 2 times during 4 years (2019-2020 and 2022-2023).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 2011 | 591/4,753 (12.4%) | 706/4,753 (14.9%) | 1,447/4,753 (30.4%) |
| Cohort 2019 | 157/3,002 (5.2%) | 234/3,002 (7.8%) | 1,474/3,002 (49.1%) |
| Event | Cohort 2011 | Cohort 2019 |
|---|---|---|
| Lungs problemsRespiratory, thoracic and mediastinal disorders | 426/4753 | 152/3002 |
| StrokeVascular disorders | 280/4753 | 82/3002 |
| Event | Cohort 2011 | Cohort 2019 |
|---|---|---|
| ArthritisMusculoskeletal and connective tissue disorders | 808/4753 | 794/3002 |
| DiabetesMetabolism and nutrition disorders | 325/4753 | 353/3002 |
| CataractEye disorders | 314/4753 | 327/3002 |
At the baseline, 4,753 participants were interviewed (2011 cohort) and in 2019-2021 3,002 participants were brought in (2019 cohort).
| Age, Categorical(Participants) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2742 | 1867 | 4609 |
| >=65 years | 2011 | 1135 | 3146 |
| Age, Continuous(years) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| Mean | 60.44 ± 16.24 | 58.19 ± 17.89 | 59.32 ± 17.07 |
| Sex: Female, Male(Participants) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| Female | 2602 | 1302 | 3904 |
| Male | 2151 | 1700 | 3851 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| Hispanic or Latino | 4753 | 3002 | 7755 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| Spain | 4753 | 3002 | 7755 |
| Education(Participants) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| No education | 373 | 100 | 473 |
| Less than primary | 1001 | 353 | 1354 |
| Primary | 1306 | 761 | 2067 |
| Secondary | 562 | 428 | 990 |
| High School | 874 | 724 | 1598 |
| University+ | 572 | 460 | 1032 |
| Post graduate degree | 64 | 175 | 239 |
| Missing data | 1 | 1 | 2 |
| Marital status(Participants) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| Single | 680 | 495 | 1175 |
| Married | 2670 | 1666 | 4336 |
| Cohabiting | 175 | 127 | 302 |
| Separated/divorced | 346 | 306 | 652 |
| Widowed | 882 | 408 | 1290 |
| Health Status(units on a scale) | Cohort 2011 Sample Demographic Characteristics | Cohort 2019 Sample Demographic Characteristics | Total |
|---|---|---|---|
| Mean | 66.55 ± 13.11 | 68.95 ± 19.87 | 67.75 ± 16.49 |
Plan to share: Undecided — A sharing plan description has to be still agreed between the different Principal Investigators
Gabarrell-Pascuet A, Varga TV, Moneta MV, Ayuso-Mateos JL, Lara E, Olaya B, Haro JM, Domenech-Abella J. What factors explain the changes in major depressive di…PubMed 36806591 ↗; 21 more. 1 publication citing this study linked from PubMed
Gabarrell-Pascuet A, Varga TV, Moneta MV, Ayuso-Mateos JL, Lara E, Olaya B, Haro JM, Domenech-Abella J. What factors explain the changes in major depressive di…PubMed 36806591 ↗; 21 more. 1 publication citing this study linked from PubMed
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa