DepressionNopsatukiNCT05356949
Effectiveness of Enhanced Mental Health Support for Young People
A study testing Intervention in people with Depression and Anxiety, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of the research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Anxiety, Emotional Stress
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score ≥14
- Willing and able to commit to the intervention and study protocol
- Sufficient proficiency in Finnish
Who cannot join
- Other ongoing mental health treatment
- Substance use as the main problem
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents.
Read the detailed description
In this study, the impact of a short psychological intervention on adolescent emotional well-being, symptoms, and functioning is assessed. The intervention is a short intervention based on the methods of cognitive-behavioral therapy comprising 6 weekly sessions. It is delivered by psychiatric nurses working in the schools in the City of Turku. The participants are adolescents aged 12-18 who seek student health care due to mental health problems. The goal is to recruit 150 participants. The intervention is not tied to some particular disorder and thus, the main response variable is emotional well-being. Emotional well-being is measured at both the beginning and the end of the intervention, and at 6-month follow-up using the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) questionnaire. Effectiveness is measured as a change in the YP-CORE scores.
- Conditions
- Depression, Anxiety, Emotional Stress
- Being tested
- Intervention
- Keywords
- Depression, Anxiety, Intervention, Adolescents, School
- Medical subject headings
- Depression, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The participants receive a psychological intervention including six weekly sessions. The intervention is based on methods of cognitive-behavioral therapy and delivered by a psychiatric nurse working in the participant's school.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participants receive a psychological intervention including six weekly sessions. The intervention is based on methods of cognitive-behavioral therapy and delivered by a psychiatric nurse working in the participant's school. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional well-being, short-term
Change from the baseline to the end of the intervention in the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score. The score range for the scale is 0-40 and lower scores indicate better emotional well-being.
Measured: 6 weeks
Secondary outcomes (1)
Emotional well-being, long-term
Change from the baseline to the 6 month follow-up time-point in the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score. The score range for the scale is 0-40 and lower scores indicate better emotional well-being.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2020
- Primary completion30 Jun 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, City of Turku
- Responsible party
- Sponsor
- Investigators
- Max Karukivi, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356949
- Sponsor's protocol ID
- 12086-2020
- Acronym
- Nopsatuki
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tornivuori A, Kronstrom K, Aromaa M, Salantera S, Karukivi M. Accessible mental well-being intervention for adolescents in school settings: a single-group intervention study using a pretest-post-test design. Child Adolesc Psychiatry Ment Health. 2023 Feb 20;17(1):28. doi: 10.1186/s13034-023-00576-0.
PubMed 36805796
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Enhanced Mental Health Support for Young People
- ClinicalTrials.gov ID
- NCT05356949
- Acronym / sponsor ID
- Nopsatuki / 12086-2020
- Conditions
- Depression, Anxiety, Emotional Stress
- Keywords
- Depression, Anxiety, Intervention, Adolescents, School
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, City of Turku
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 May 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 research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents.
Detailed description
In this study, the impact of a short psychological intervention on adolescent emotional well-being, symptoms, and functioning is assessed. The intervention is a short intervention based on the methods of cognitive-behavioral therapy comprising 6 weekly sessions. It is delivered by psychiatric nurses working in the schools in the City of Turku. The participants are adolescents aged 12-18 who seek student health care due to mental health problems. The goal is to recruit 150 participants. The intervention is not tied to some particular disorder and thus, the main response variable is emotional well-being. Emotional well-being is measured at both the beginning and the end of the intervention, and at 6-month follow-up using the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) questionnaire. Effectiveness is measured as a change in the YP-CORE scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe participants receive a psychological intervention including six weekly sessions. The intervention is based on methods of cognitive-behavioral therapy and delivered by a psychiatric nurse working in the participant's school. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score ≥14
- Willing and able to commit to the intervention and study protocol
- Sufficient proficiency in Finnish
Key exclusion criteria (2 listed)
- Other ongoing mental health treatment
- Substance use as the main problem
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 |
|---|---|---|
| InterventionThe participants receive a psychological intervention including six weekly sessions. The intervention is based on methods of cognitive-behavioral therapy and delivered by a psychiatric nurse working in the participant's school. | Behavioural | Intervention |
Primary outcome
Emotional well-being, short-term
Time frame: 6 weeks
Change from the baseline to the end of the intervention in the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score. The score range for the scale is 0-40 and lower scores indicate better emotional well-being.
1 secondary outcome
Emotional well-being, long-term
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 36805796Tornivuori A, Kronstrom K, Aromaa M, Salantera S, Karukivi M. Accessible mental well-being intervention for adolescents in school settings: a single-group intervention study using a pretest-post-test design. Child Adolesc Psychiatry Ment Health. 2023 Feb 20;17(1):28. doi: 10.1186/s13034-023-00576-0.
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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.
Max Karukivi, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Depression and Anxiety, run by Turku University Hospital at 1 site in Finland.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jun 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 Finland. 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?
Results are not available in the source record.
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?
Emotional well-being, short-term (time frame: 6 weeks). 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 NCT05356949, which also lists 1 linked publication.
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 18 Jun 2023.