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NCT Number: NCT05087446

Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mental Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nidelv DPS, Tiller

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Early assessment team

Behavioral

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 clinic

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. World Health Organization Well Being Index (WHO-5)

    Time frame: 2, 4, 8, 12, 24 months after enrollment

    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).

  2. EuroQoL EQ-5D-5L

    Time frame: 2, 4, 8, 12, 24 months after enrollment

    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.

  3. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Through study completion, an average of 1 year

    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.

  4. Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)

    Time frame: 12, 24 months after enrollment

    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).

  5. Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)

    Time frame: 2, 4, 8 months after enrollment

    A self-administered short form of CORE-OM (see outcome 5) with 10 items

  6. The Questionaire about the Process of Recovery (QPR-15)

    Time frame: 2, 4, 8, 12, 24 months after enrollment

    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).

  7. Occupational status - data extracted from The Norwegian Labour and Welfare Administration (NAV)

    Time frame: 12 and 24 months

    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.

  8. Work and Social Adjustment Scale (WSAS)

    Time frame: 2, 4, 8, 24 months after enrollment

    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.

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Effect of Early Assessment Team for Clarification and Follow-up of Patients Referred to Outpatient Mental Health Care: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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