Psychological DistressDistressEANCT04596345
Psychological Distress in Emerging Adulthood: A Longitudinal Study
An observational study of Psychological Distress, run by Universidad de las Americas - Quito at 1 site in Ecuador.
Trial summary
Emerging adulthood (18-29 years) is a critical stage in lifespan development. During this stage, people experience instability: shifts from their families of origin, breakups of relationships and job changes are frequent before most young adults stabilize their lives and make more lasting decisions. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- How many people
- 1,168 participants
- Where
- 1 siteEcuador
- Study dates
- 15 Oct 2020to 30 Jun 2023
- Phase
- Observational
- 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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population will be emerging adults from Ecuador students and non-students as one objective is to compare psychological distress variability between both populations.
Who may be able to join
- Competence to read and understand Spanish
- Living in Ecuador
- Being a student (for the student cohort)
- Not attending to a formal student program (for the non-student cohort)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Emerging adulthood (18-29 years) is a critical stage in lifespan development. During this stage, people experience instability: shifts from their families of origin, breakups of relationships and job changes are frequent before most young adults stabilize their lives and make more lasting decisions. This study seeks to understand the psychological distress of emerging adults in Quito, Ecuador and define how it varies over a year.
Read the detailed description
Emerging adulthood is often a period of some instability with relationship changes and often a series of job changes before life trajectories clarify and more lasting decisions are possible. These changes often produce distress and they might explain why most of the symptoms that impact the individual's mental health throughout their lives appear at this stage, although full-blown disorders are often only diagnosed subsequently. There are several studies that describe the prevalence of mental disorders in this age group, however, there are few studies that refer to how psychological distress changes during this phase of emotional, social, and financial instability. The few existent studies refer mostly to college student populations, with relative neglect of the non-student populations.
The objective of this study is to analyze the intraindividual changes in psychological distress of emerging adults over one year. These changes will be compared between those participants who are college students and those who are not. Sociodemographic data will be recorded in the first assessment and the last assessment, while psychological distress and health-related quality of life will be monitored bimonthly for seven assessment points in total. Everyday relevant events will be also recorded bimonthly for seven assessment points, and this information will be used as a time-varying covariate. An electronic survey will be used for data collection through formr system (https://formr.org/).
The results of this research will show if the distress changes significantly in the studied population for one year and it will be possible to identify some of the events and variables that are related to these changes. This knowledge might help to create interventions that are tailored to the needs of this population.
- Conditions
- Psychological Distress
- Keywords
- Young Adult, Life Change Events, Students, Mental Health, Observational Study, Longitudinal Studies, Surveys and Questionnaires, Self Report
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| University students | This group will include all those participants who declare to be attending a study program to get a higher education degree. No intervention will be applied. | |
| Non-university-attending peers | This group will include all those participants who are not attending a study program to get a higher education degree. No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Clinical Outcomes in Routine Evaluation (CORE)
A 34-item self-reported measure that assess psychological distress and how it changes considering four dimensions: subjective well-being (four items), problems and or symptoms (twelve items), life function (twelve items) and risk to self and others (six items). Higher scores indicate higher psychological distress. It is measure that can be downloaded free of charge from: www.coresystemtrust.org.uk. The Clinical Outcomes in Routine Evaluation- Outcome Measure(CORE-OM) has shown good psychometric properties in college students (and a non-student general population sample) from Ecuador (http://dx.doi.org/10.1186/s40359-020-00443-z)
Measured: One year (seven assessment points at two-month intervals)
Secondary outcomes (2)
EuroQol five-dimensions - three-level (EQ-5D-3L)
A 5-item self-report measure of health-related quality of life states in adults, considering five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& Depression), each of which has three severity levels that are described by statements appropriate to that dimension. As result a 5-digit number describes person's health state profile. Higher scores represent more problems with regard to each dimension.
Measured: One year (seven assessment points at two-month intervals)
EuroQol Visual Analogue Scale (EQ VAS)
This scale records the patient's self-rated health on a vertical visual analogue scale that ranges from 0= 'Best imaginable health state' to 100 = 'Worst imaginable health state'. The VAS will be used as a quantitative measure of health outcome .
Measured: One year (seven assessment points at two-month intervals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion7 Mar 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de las Americas - Quito
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Paz, Universidad de las Americas - Quito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596345
- Sponsor's protocol ID
- PSI.CPE.20.01
- Acronym
- DistressEA
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2020
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paz C, Evans C. A comparison of mental health of student and not student emerging adults living in Ecuador. Sci Rep. 2023 Jan 27;13(1):1487. doi: 10.1038/s41598-023-27695-0.
PubMed 36707675Paz C, Osejo-Taco G, Evans C. Trajectories of success and/or distress: protocol for an observational cohort study investigating changing psychological distress among emerging Ecuadorian adults over a year. BMJ Open. 2021 Dec 20;11(12):e056361. doi: 10.1136/bmjopen-2021-056361.
PubMed 34930747
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Distress in Emerging Adulthood: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04596345
- Acronym / sponsor ID
- DistressEA / PSI.CPE.20.01
- Conditions
- Psychological Distress
- Keywords
- Young Adult, Life Change Events, Students, Mental Health, Observational Study, Longitudinal Studies, Surveys and Questionnaires, Self Report
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- Universidad de las Americas - QuitoUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Oct 2020 (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.
Emerging adulthood (18-29 years) is a critical stage in lifespan development. During this stage, people experience instability: shifts from their families of origin, breakups of relationships and job changes are frequent before most young adults stabilize their lives and make more lasting decisions. This study seeks to understand the psychological distress of emerging adults in Quito, Ecuador and define how it varies over a year.
Detailed description
Emerging adulthood is often a period of some instability with relationship changes and often a series of job changes before life trajectories clarify and more lasting decisions are possible. These changes often produce distress and they might explain why most of the symptoms that impact the individual's mental health throughout their lives appear at this stage, although full-blown disorders are often only diagnosed subsequently. There are several studies that describe the prevalence of mental disorders in this age group, however, there are few studies that refer to how psychological distress changes during this phase of emotional, social, and financial instability. The few existent studies refer mostly to college student populations, with relative neglect of the non-student populations.
The objective of this study is to analyze the intraindividual changes in psychological distress of emerging adults over one year. These changes will be compared between those participants who are college students and those who are not. Sociodemographic data will be recorded in the first assessment and the last assessment, while psychological distress and health-related quality of life will be monitored bimonthly for seven assessment points in total. Everyday relevant events will be also recorded bimonthly for seven assessment points, and this information will be used as a time-varying covariate. An electronic survey will be used for data collection through formr system (https://formr.org/).
The results of this research will show if the distress changes significantly in the studied population for one year and it will be possible to identify some of the events and variables that are related to these changes. This knowledge might help to create interventions that are tailored to the needs of this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| University students | – | –This group will include all those participants who declare to be attending a study program to get a higher education degree. No intervention will be applied. |
| Non-university-attending peers | – | –This group will include all those participants who are not attending a study program to get a higher education degree. No intervention will be applied. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population will be emerging adults from Ecuador students and non-students as one objective is to compare psychological distress variability between both populations.
Key inclusion criteria (4 listed)
- Competence to read and understand Spanish
- Living in Ecuador
- Being a student (for the student cohort)
- Not attending to a formal student program (for the non-student cohort)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change on the Clinical Outcomes in Routine Evaluation (CORE)
Time frame: One year (seven assessment points at two-month intervals)
A 34-item self-reported measure that assess psychological distress and how it changes considering four dimensions: subjective well-being (four items), problems and or symptoms (twelve items), life function (twelve items) and risk to self and others (six items). Higher scores indicate higher psychological distress. It is measure that can be downloaded free of charge from: www.coresystemtrust.org.uk. The Clinical Outcomes in Routine Evaluation- Outcome Measure(CORE-OM) has shown good psychometric properties in college students (and a non-student general population sample) from Ecuador (http://dx.doi.org/10.1186/s40359-020-00443-z)
2 secondary outcomes
EuroQol five-dimensions - three-level (EQ-5D-3L)
Time frame: One year (seven assessment points at two-month intervals)
EuroQol Visual Analogue Scale (EQ VAS)
Time frame: One year (seven assessment points at two-month intervals)
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 Oct 2023.
- Derived from this study: PubMed 36707675Paz C, Evans C. A comparison of mental health of student and not student emerging adults living in Ecuador. Sci Rep. 2023 Jan 27;13(1):1487. doi: 10.1038/s41598-023-27695-0.
- Derived from this study: PubMed 34930747Paz C, Osejo-Taco G, Evans C. Trajectories of success and/or distress: protocol for an observational cohort study investigating changing psychological distress among emerging Ecuadorian adults over a year. BMJ Open. 2021 Dec 20;11(12):e056361. doi: 10.1136/bmjopen-2021-056361.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Psychological Distress, run by Universidad de las Americas - Quito at 1 site in Ecuador.
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 Oct 2023. 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 Ecuador. 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?
Change on the Clinical Outcomes in Routine Evaluation (CORE) (time frame: One year (seven assessment points at two-month intervals)). 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 NCT04596345, which also lists 2 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 Oct 2023.