Mental DisorderNCT05087446
Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care
A study testing Early assessment team and Admission to General psychiatric outpatient clinic in people with Mental Disorder, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Early assessment team and Admission to General psychiatric outpatient clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 1 siteNorway
- Study dates
- 26 Oct 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients referred to a general psychiatric outpatient clinic
- necessary capacity to consent
- master Norwegian language to such an extent that the patient can understand the written consent
Who cannot join
- patients that an admission team at the outpatient clinic consider obviously must have a TAU for some time
- patients too healthy to receive specialized mental health care
- patients in need of acute psychiatric assessment
- relevant participants who do not respond digitally or who do not confirm consent in writing within given deadlines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Assessment Team for Clarification and Follow-up of Patients Referred to Outpatient Mental Health Care: A Randomized Controlled Trial
Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition.
With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence.
The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.
- Conditions
- Mental Disorder
- Being tested
- Early assessment team, Admission to General psychiatric outpatient clinic
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early assessment teamBehavioural
Early assessment team (EAT):The patients receive their first assessment by an early clarification team within a few weeks after the team receiving the referral. The team then decides whether further assessment and/or treatment should be given in the general outpatient clinic, and/or whether any other follow-up may be appropriate. In the first meeting the patient preferably meets two therapists, who conduct a semi-structured interview with focus on health and level of functioning. If considered appropriate, the team may offer a short-term intervention.
Admission to General psychiatric outpatient clinicBehavioural
Ordinary procedures for admission to an outpatient clinic are followed in accordance with the Norwegian Directorate of Health's national prioritization guide. Referrals are assessed on the basis of severity and placed on a regular waiting list (usually a waiting period of 1-3 months). The patients receive their first personal assessment from a therapist in a general outpatient clinic who takes a position on what is to be initiated and, if necessary, offers further assessment / treatment in accordance with procedures in the outpatient clinics. This is not standardized beyond current practice.
| Study group | Role | What they receive |
|---|---|---|
| Early assessment group | Experimental | Not described Receives: Behavioral: Early assessment team |
| Usual admission procedure group | Active comparator | Not described Receives: Behavioral: Admission to General psychiatric outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work and Social Adjustment Scale (WSAS)
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.
Measured: 1 year
Secondary outcomes (8)
World Health Organization Well Being Index (WHO-5)
The World Health Organization Well Being Index is one of the most widely used measures of subjective psychological well-being that is also a measure of depression. The scale consists of 5 questions about participants well-being experienced during the past 2 weeks. Items are rated on a 6-point scale from 0 (never) to 5 (all the time).
Measured: 2, 4, 8, 12, 24 months after enrollment
EuroQoL EQ-5D-5L
EuroQoL EQ-5D-5L is used to measure health outcomes and perform health economic analyzes. The form consists of 5 questions covering walking, personal care, daily tasks, pain / discomfort and anxiety / depression. In addition, the patient must indicate their own state of health on a VAS scale from 0-100.
Measured: 2, 4, 8, 12, 24 months after enrollment
Client Satisfaction Questionnaire (CSQ-8)
The measure yields a continuous score on a single factor of general satisfaction. This is derived from eight questions about the quality of service, the kind of service, patients' outcomes and overall satisfaction. The scale is rated on a 4-point response scale.
Measured: Through study completion, an average of 1 year
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)
A self-administered questionnaire with 34 items related to the preceding week mapping 4 main areas; well-being (4 elements), problems (12 elements), function (12 elements) og risk (6 elements). All items are scored from "Never" (=0) to "Almost all the time" (=4).
Measured: 12, 24 months after enrollment
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)
A self-administered short form of CORE-OM (see outcome 5) with 10 items
Measured: 2, 4, 8 months after enrollment
The Questionaire about the Process of Recovery (QPR-15)
The scale is used to capture peoples' accounts of recovery from severe mental illness. The 15-item version has been recommended for use both in routine clinical work and in research, and it is scored on a 5-point scale from 0 = disagree strongly to 4 = agree strongly).
Measured: 2, 4, 8, 12, 24 months after enrollment
Occupational status - data extracted from The Norwegian Labour and Welfare Administration (NAV)
The Norwegian Labour and Welfare Administration (NAV) have data on all citizens working status and sick leaves lasting for more than two weeks. Extracted data will include information such as sick- and disability leaves until 12 and 24 months after enrolment.
Measured: 12 and 24 months
Work and Social Adjustment Scale (WSAS)
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.
Measured: 2, 4, 8, 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start26 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (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 Mental DisorderStudies of the same condition, open and under way.
- More trials run by St. Olavs 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Jon Helle, MD, Study chair, Nidelv DPS, Tiller, St.Olavs hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087446
- Sponsor's protocol ID
- 244508
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kvestad CA, Holte IR, Reitan SK, Chiappa CS, Helle GK, Skjervold AE, Rosenlund AMA, Watne O, Brattland H, Helle J, Follestad T, Hara KW, Holgersen KH. Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial. Trials. 2024 Mar 11;25(1):179. doi: 10.1186/s13063-024-08028-6.
PubMed 38468321
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Assessment Team for Clarification and Follow-up of Patients Referred to Outpatient Mental Health Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05087446
- Acronym / sponsor ID
- 244508
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Oct 2021 (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.
Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition.
With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence.
The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early assessment group | Experimental | Behavioral: Early assessment team |
| Usual admission procedure group | Active comparator | Behavioral: Admission to General psychiatric outpatient clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients referred to a general psychiatric outpatient clinic
- necessary capacity to consent
- master Norwegian language to such an extent that the patient can understand the written consent
Key exclusion criteria (4 listed)
- patients that an admission team at the outpatient clinic consider obviously must have a TAU for some time
- patients too healthy to receive specialized mental health care
- patients in need of acute psychiatric assessment
- relevant participants who do not respond digitally or who do not confirm consent in writing within given deadlines
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 |
|---|---|---|
| Early assessment teamEarly assessment team (EAT):The patients receive their first assessment by an early clarification team within a few weeks after the team receiving the referral. The team then decides whether further assessment and/or treatment should be given in the general outpatient clinic, and/or whether any other follow-up may be appropriate. In the first meeting the patient preferably meets two therapists, who conduct a semi-structured interview with focus on health and level of functioning. If considered appropriate, the team may offer a short-term intervention. | Behavioural | Early assessment group |
| Admission to General psychiatric outpatient clinicOrdinary procedures for admission to an outpatient clinic are followed in accordance with the Norwegian Directorate of Health's national prioritization guide. Referrals are assessed on the basis of severity and placed on a regular waiting list (usually a waiting period of 1-3 months). The patients receive their first personal assessment from a therapist in a general outpatient clinic who takes a position on what is to be initiated and, if necessary, offers further assessment / treatment in accordance with procedures in the outpatient clinics. This is not standardized beyond current practice. | Behavioural | Usual admission procedure group |
Primary outcome
Work and Social Adjustment Scale (WSAS)
Time frame: 1 year
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.
8 secondary outcomes
World Health Organization Well Being Index (WHO-5)
Time frame: 2, 4, 8, 12, 24 months after enrollment
EuroQoL EQ-5D-5L
Time frame: 2, 4, 8, 12, 24 months after enrollment
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Through study completion, an average of 1 year
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)
Time frame: 12, 24 months after enrollment
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)
Time frame: 2, 4, 8 months after enrollment
The Questionaire about the Process of Recovery (QPR-15)
Time frame: 2, 4, 8, 12, 24 months after enrollment
Occupational status - data extracted from The Norwegian Labour and Welfare Administration (NAV)
Time frame: 12 and 24 months
Work and Social Adjustment Scale (WSAS)
Time frame: 2, 4, 8, 24 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 38468321Kvestad CA, Holte IR, Reitan SK, Chiappa CS, Helle GK, Skjervold AE, Rosenlund AMA, Watne O, Brattland H, Helle J, Follestad T, Hara KW, Holgersen KH. Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial. Trials. 2024 Mar 11;25(1):179. doi: 10.1186/s13063-024-08028-6.
- 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.
Jon Helle, MD study chair
Nidelv DPS, Tiller, St.Olavs 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 Early assessment team and Admission to General psychiatric outpatient clinic in people with Mental Disorder, run by St. Olavs Hospital at 1 site in Norway.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Work and Social Adjustment Scale (WSAS) (time frame: 1 year). 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 NCT05087446, 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 6 Feb 2026.