NCT05087446

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2021Dec 2026

First Submitted

Initial submission to the registry

September 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

September 13, 2021

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (8)

  • World Health Organization Well Being Index (WHO-5)

    2, 4, 8, 12, 24 months after enrollment

  • EuroQoL EQ-5D-5L

    2, 4, 8, 12, 24 months after enrollment

  • Client Satisfaction Questionnaire (CSQ-8)

    Through study completion, an average of 1 year

  • Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)

    12, 24 months after enrollment

  • Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)

    2, 4, 8 months after enrollment

  • +3 more secondary outcomes

Study Arms (2)

Early assessment group

EXPERIMENTAL
Behavioral: Early assessment team

Usual admission procedure group

ACTIVE COMPARATOR
Behavioral: Admission to General psychiatric outpatient clinic

Interventions

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.

Early assessment group

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.

Usual admission procedure group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nidelv DPS, Tiller

Trondheim, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Jon Helle, MD

    Nidelv DPS, Tiller, St.Olavs hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 21, 2021

Study Start

October 26, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations