<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786328</url>
  </required_header>
  <id_info>
    <org_study_id>2013-18</org_study_id>
    <nct_id>NCT03786328</nct_id>
  </id_info>
  <brief_title>An Outreach Collaborative Model for Early Identification and Treatment of Mental Disorder in Danish Workplaces</brief_title>
  <official_title>An Outreach Collaborative Model for Early Identification and Treatment of Mental Disorder in Danish Workplaces</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helle Østermark Sørensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spar Nord Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression and anxiety are prevalent mental disorders among the working population with&#xD;
      potentially high personal and financial cost. The aim of the study is to test the&#xD;
      applicability of an outreach collaborative model for early identification and treatment of&#xD;
      clinical and sub-clinical mental disorders among Danish employees. applicability was examined&#xD;
      by I) investigating the fractions of identified and treated clinical and subclinical cases,&#xD;
      II) describing the distribution and characteristics of cases identified and III)&#xD;
      investigating the effect of allocated treatment.&#xD;
&#xD;
      A longitudinal study design with four assessments over 16 months are applied. Six&#xD;
      medium-large companies will be included, both public and private cooperations. Self-reporting&#xD;
      questionnaires probing for psychopathology will be distributed to all employees in the six&#xD;
      consecutively enrolled companies at the four time points. Employees meeting the screening&#xD;
      criteria at T1 will be assessed diagnostically. Subjects diagnosed with a clinical mental&#xD;
      disorder will be allocated to outpatient psychiatric treatment, and subjects with subclinical&#xD;
      conditions will be allocated to preventive cognitive behavioural therapy. Follow-up is&#xD;
      conducted 6 and 12 months after initiation of treatment.&#xD;
&#xD;
      Participation in the study is voluntary at all levels. Written informed consent will be&#xD;
      obtained from participant selected for diagnostic interview and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      Common mental disorders, like depression and anxiety are prevalent mental disorders among the&#xD;
      working population with prevalence's of approximately 3% respectively. These disorder induce&#xD;
      high personal and financial cost, due to increased number of sick days, impaired functioning&#xD;
      - socially and professionally, reduced job satisfaction and reduced quality of life and an&#xD;
      increased risk of loss of work.&#xD;
&#xD;
      In addition to clinical conditions, many employees are affected by symptoms of depression and&#xD;
      anxiety at a subclinical level which can be socially inhibiting for the individual as well as&#xD;
      negatively impacting job satisfaction, work productivity and attendance. Untreated and not&#xD;
      early identified, these subclinical cases can lead to actual mental disorder.&#xD;
&#xD;
      In both the general population and the working population, evidence has demonstrated a high&#xD;
      level of unmet need for mental health care and treatment. The unmet needs are partly&#xD;
      explained by diagnostic difficulties and inadequate treatment in general practice, and partly&#xD;
      by the fact that many individuals affected do not seek professional help.&#xD;
&#xD;
      In light of the high costs and unmet need for treatment, prevention and early detection of&#xD;
      mental disorders among the working population ought to be a public health priority. Evidence&#xD;
      suggests that much could be gained by investing in preventive initiatives.&#xD;
&#xD;
      Research studies within occupational mental health have mainly tested workplace-initiated&#xD;
      stress management programmes or other universal prevention programmes using work-related&#xD;
      outcome measures like sickness absence, work productivity and cost-effectiveness. Secondary&#xD;
      prevention and early intervention programmes targeting mental health problems directly by&#xD;
      using clinical standardized measures of depression or anxiety are limited, or suffer from&#xD;
      limitations such as weak control conditions, short-term follow-up and lack of diagnostic&#xD;
      assessment.&#xD;
&#xD;
      When targeting workplace mental health problems, it is recommended to apply a collaborative&#xD;
      approach between workplaces and mental health specialists in order to minimize the risk of&#xD;
      misclassification and inadequate treatment .&#xD;
&#xD;
      For this study, the investigators therefore developed an outreach secondary prevention model&#xD;
      to be tested in collaboration between the psychiatric treatment system and workplaces in the&#xD;
      North Denmark Region.&#xD;
&#xD;
      AIM:&#xD;
&#xD;
      The overall aim of the study was to investigate the applicability of an outreach&#xD;
      collaborative model for early identification and treatment of clinical and sub-clinical cases&#xD;
      of mental disorder among a Danish working population. The investigation had the following&#xD;
      objectives:&#xD;
&#xD;
      I) To investigate the applicability of the early identification model, measured as fractions&#xD;
      of identified clinical and subclinical cases, fraction of cases who accepted treatment and&#xD;
      fraction of cases who completed treatment II) To describe the distribution and characteristic&#xD;
      of clinical and subclinical cases identified by the early identification model III) To&#xD;
      investigate the effect of allocated treatment on symptomatology for clinical and subclinical&#xD;
      cases&#xD;
&#xD;
      METHOD:&#xD;
&#xD;
      Study design The study applies a longitudinal naturalistic design with four points of&#xD;
      assessment (T0-T3) during a period of 16 months for each participating company. The time from&#xD;
      T0 to T1 (4 months) constitutes a pre-treatment period and is incorporated in the design as a&#xD;
      control period for comparison. After the second assessment (T1), screening and diagnostic&#xD;
      assessment will be initiated. Identified cases will afterwards be allocated to treatment.&#xD;
      Follow-up assessments are conducted after 6 months (T2) and 12 months (T3) for all employees.&#xD;
      The assessments uses self-reporting questionnaires probing for psychopathology. All&#xD;
      questionnaires are mailed to the employees' private postal addresses at the four points of&#xD;
      assessment (T0-T3) followed by a reminder after two weeks in case of no response.&#xD;
&#xD;
      Participants In order to demonstrate the model's applicability in a representative sample,&#xD;
      the investigators will enrol six medium-large companies with a minimum of 100 employees each.&#xD;
      Companies with more than 300 employees will not be addressed due to the limitations of the&#xD;
      available treatment capacity.&#xD;
&#xD;
      Measures The questionnaires used the Symptom Check List 90 Revised (SCL90-R) [30] as basis&#xD;
      for identification of clinical and subclinical cases of mental disorders and follow-up to&#xD;
      treatment. Questionnaires also collected data on demography, different work-related&#xD;
      characteristics and job-satisfaction.&#xD;
&#xD;
      The following screening criteria for identification of clinical and subclinical cases of&#xD;
      mental disorder is used:&#xD;
&#xD;
      i) Global Severity Index score &gt; 0.63 or ii) values of &gt; 0.63 in two or more subscales or&#xD;
      iii) values of &gt; 0.63 in the Depression subscale&#xD;
&#xD;
      Procedure Participants meeting the screening criteria at the second assessment (T1) will be&#xD;
      invited to a diagnostic assessment in order to determine the presence of a mental disorder.&#xD;
      The diagnostic interviews will be conducted by medical doctors at Aalborg Psychiatric&#xD;
      Hospital, all trained and experienced user of the diagnostic instruments utilized. The&#xD;
      presence of a mental disorder will initially be determined by use of Present State&#xD;
      Examination (PSE). Participants assessed with a state of anxiety or depression will&#xD;
      afterwards be rated on the Hamilton Depression Scale (HAM-D) and/or Hamilton Anxiety Scale&#xD;
      (HAM-A) to assess the severity of the condition. Depending on the outcome of the diagnostic&#xD;
      interview, participants will be offered two different courses of treatment:&#xD;
&#xD;
      Treatment course I: Psychiatric treatment for clinical cases Individuals diagnosed with a&#xD;
      mental disorder according to the PSE, and with HAM-D score ≥ 18 or HAM-A score ≥ 20, will be&#xD;
      referred to psychiatric treatment in an outpatient specialized clinic for affective disorders&#xD;
      at Aalborg Psychiatric Hospital. The treatment will follow standard treatment procedures for&#xD;
      psychiatric outpatients with diagnoses of depression and anxiety. Treatment is performed by&#xD;
      trained clinicians (psychiatrists, psychologists and nurses) employed at the Clinic for&#xD;
      Affective Disorders. The course of treatment includes medical consultations as well as&#xD;
      psychotherapeutic sessions and treatment will continue until remission is achieved.&#xD;
&#xD;
      Treatment course II: Preventive treatment for subclinical cases Individuals assessed with&#xD;
      subclinical conditions of depression or anxiety, defined as a HAM-D score of 13-17 or a HAM-A&#xD;
      score of 15-19, are offered preventive treatment. This course of treatment consists of eight&#xD;
      sessions of cognitive behavioral therapy (CBT) conducted by clinical psychologists at Aalborg&#xD;
      Psychiatric Hospital. During the sessions, the therapeutic focus is on stress-reduction and&#xD;
      resilience.&#xD;
&#xD;
      Statistical analysis The primary analysis are carried out by counting the number of clinical&#xD;
      and subclinical cases identified from the early identification procedure. Secondly, the&#xD;
      investigators will perform a descriptive analysis with the study population allocated into&#xD;
      four groups: clinical cases, subclinical cases, untreated cases and healthy subjects. Groups&#xD;
      will be compared at baseline (T1) on demography, work-related characteristics and the three&#xD;
      outcome measures Global Severity Index, Depression and Anxiety.&#xD;
&#xD;
      To analyze the effect of both treatments, the investigators will use mixed effects linear&#xD;
      regression using random intercept and with participants nested inside the companies. A&#xD;
      p-value &lt; 0.05 was considered statistically significant.&#xD;
&#xD;
      Ethics Information about the study are initially provided to the workplace management and the&#xD;
      health and safety representatives and subsequently to all employees at joint open meetings.&#xD;
&#xD;
      It is emphasized that the study is voluntary at all levels. Written participant information&#xD;
      will accompany all questionnaires. The return of the questionnaires will be considered as&#xD;
      acceptance of participation in the questionnaire part. Written informed consent will be&#xD;
      obtained from all participants involved in diagnostic interview and treatment. The employees&#xD;
      are guaranteed complete anonymity in relation to their workplace and company management. The&#xD;
      study are approved by the Danish Data Protection Agency (j. 2008-58-0028). The study was&#xD;
      presented to the Danish Scientific Ethics Committee (N-20070016), but the need for approval&#xD;
      was waived due to the nature of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2008</start_date>
  <completion_date type="Actual">August 31, 2013</completion_date>
  <primary_completion_date type="Actual">August 31, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Severity of Psychopathological symptoms</measure>
    <time_frame>Measured at baseline and 6 and 12 month follow-up</time_frame>
    <description>The change in severity of psychopathological symptoms are measured with the Symptom Checklist 90, revised (SCL-90-R) that is a psychiatric self-report inventory with high reliability and validity to measure overall psychological distress and to detect changes.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Clinical cases of Mental Disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The group of individuals identified with a clinical mental disorder on the basis of the diagnostic interviews This group will be assigned to Standard Psychiatric Treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subclinical cases of Mental Disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The group of individuals identified with a sub-clinical mental condition on the basis of the diagnostic interviews This group will be assigned to Preventive Psychological Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Psychiatric Treatment</intervention_name>
    <description>Standard psychiatric treatment is offered individuals identified with a clinical mental disorder. Treatment will follow golden standard treatment in the psychiatric clinic, meaning a combination of therapy and psychopharmacological treatment.</description>
    <arm_group_label>Clinical cases of Mental Disorder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preventive Psychological Treatment</intervention_name>
    <description>Preventive Psychological Treatment is offered individuals identified with a sub-clinical mental condition. Treatment consists of 8 sessions of cognitive-behavioural therapy.</description>
    <arm_group_label>Subclinical cases of Mental Disorder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Individuals for the diagnostic interview and treatment are selected on the basis of their&#xD;
        response to the SCL-90-R questionnaire.&#xD;
&#xD;
        Hence, individuals are included in diagnostic interview, if scores on the SCL90-R inventory&#xD;
        one of the following criteria:&#xD;
&#xD;
          -  Global Severity Index score &gt; 0.63 or&#xD;
&#xD;
          -  values of &gt; 0.63 in two or more subscales or&#xD;
&#xD;
          -  values of &gt; 0.63 in the Depression subscale&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Individuals not meeting the above screening criteria will not participate in&#xD;
             diagnostic interview and treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg Psychiatric Hospital</investigator_affiliation>
    <investigator_full_name>Helle Østermark Sørensen</investigator_full_name>
    <investigator_title>MHSc, Research Nurse</investigator_title>
  </responsible_party>
  <keyword>Early detection and treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786328
org study id: 2013-18
nct id: NCT03786328
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Depression and anxiety are prevalent mental disorders among the working population with
      potentially high personal and financial cost. The aim of the study is to test the
      applicability of an outreach collaborative model for early identification and treatment of
      clinical and sub-clinical mental disorders among Danish employees. applicability was examined
      by I) investigating the fractions of identified and treated clinical and subclinical cases,
      II) describing the distribution and characteristics of cases identified and III)
      investigating the effect of allocated treatment.

      A longitudinal study design with four assessments over 16 months are applied. Six
      medium-large companies will be included, both public and private cooperations. Self-reporting
      questionnaires probing for psychopathology will be distributed to all employees in the six
      consecutively enrolled companies at the four time points. Employees meeting the screening
      criteria at T1 will be assessed diagnostically. Subjects diagnosed with a clinical mental
      disorder will be allocated to outpatient psychiatric treatment, and subjects with subclinical
      conditions will be allocated to preventive cognitive behavioural therapy. Follow-up is
      conducted 6 and 12 months after initiation of treatment.

      Participation in the study is voluntary at all levels. Written informed consent will be
      obtained from participant selected for diagnostic interview and treatment.
BACKGROUND:

      Common mental disorders, like depression and anxiety are prevalent mental disorders among the
      working population with prevalence's of approximately 3% respectively. These disorder induce
      high personal and financial cost, due to increased number of sick days, impaired functioning
      - socially and professionally, reduced job satisfaction and reduced quality of life and an
      increased risk of loss of work.

      In addition to clinical conditions, many employees are affected by symptoms of depression and
      anxiety at a subclinical level which can be socially inhibiting for the individual as well as
      negatively impacting job satisfaction, work productivity and attendance. Untreated and not
      early identified, these subclinical cases can lead to actual mental disorder.

      In both the general population and the working population, evidence has demonstrated a high
      level of unmet need for mental health care and treatment. The unmet needs are partly
      explained by diagnostic difficulties and inadequate treatment in general practice, and partly
      by the fact that many individuals affected do not seek professional help.

      In light of the high costs and unmet need for treatment, prevention and early detection of
      mental disorders among the working population ought to be a public health priority. Evidence
      suggests that much could be gained by investing in preventive initiatives.

      Research studies within occupational mental health have mainly tested workplace-initiated
      stress management programmes or other universal prevention programmes using work-related
      outcome measures like sickness absence, work productivity and cost-effectiveness. Secondary
      prevention and early intervention programmes targeting mental health problems directly by
      using clinical standardized measures of depression or anxiety are limited, or suffer from
      limitations such as weak control conditions, short-term follow-up and lack of diagnostic
      assessment.

      When targeting workplace mental health problems, it is recommended to apply a collaborative
      approach between workplaces and mental health specialists in order to minimize the risk of
      misclassification and inadequate treatment .

      For this study, the investigators therefore developed an outreach secondary prevention model
      to be tested in collaboration between the psychiatric treatment system and workplaces in the
      North Denmark Region.

      AIM:

      The overall aim of the study was to investigate the applicability of an outreach
      collaborative model for early identification and treatment of clinical and sub-clinical cases
      of mental disorder among a Danish working population. The investigation had the following
      objectives:

      I) To investigate the applicability of the early identification model, measured as fractions
      of identified clinical and subclinical cases, fraction of cases who accepted treatment and
      fraction of cases who completed treatment II) To describe the distribution and characteristic
      of clinical and subclinical cases identified by the early identification model III) To
      investigate the effect of allocated treatment on symptomatology for clinical and subclinical
      cases

      METHOD:

      Study design The study applies a longitudinal naturalistic design with four points of
      assessment (T0-T3) during a period of 16 months for each participating company. The time from
      T0 to T1 (4 months) constitutes a pre-treatment period and is incorporated in the design as a
      control period for comparison. After the second assessment (T1), screening and diagnostic
      assessment will be initiated. Identified cases will afterwards be allocated to treatment.
      Follow-up assessments are conducted after 6 months (T2) and 12 months (T3) for all employees.
      The assessments uses self-reporting questionnaires probing for psychopathology. All
      questionnaires are mailed to the employees' private postal addresses at the four points of
      assessment (T0-T3) followed by a reminder after two weeks in case of no response.

      Participants In order to demonstrate the model's applicability in a representative sample,
      the investigators will enrol six medium-large companies with a minimum of 100 employees each.
      Companies with more than 300 employees will not be addressed due to the limitations of the
      available treatment capacity.

      Measures The questionnaires used the Symptom Check List 90 Revised (SCL90-R) [30] as basis
      for identification of clinical and subclinical cases of mental disorders and follow-up to
      treatment. Questionnaires also collected data on demography, different work-related
      characteristics and job-satisfaction.

      The following screening criteria for identification of clinical and subclinical cases of
      mental disorder is used:

      i) Global Severity Index score > 0.63 or ii) values of > 0.63 in two or more subscales or
      iii) values of > 0.63 in the Depression subscale

      Procedure Participants meeting the screening criteria at the second assessment (T1) will be
      invited to a diagnostic assessment in order to determine the presence of a mental disorder.
      The diagnostic interviews will be conducted by medical doctors at Aalborg Psychiatric
      Hospital, all trained and experienced user of the diagnostic instruments utilized. The
      presence of a mental disorder will initially be determined by use of Present State
      Examination (PSE). Participants assessed with a state of anxiety or depression will
      afterwards be rated on the Hamilton Depression Scale (HAM-D) and/or Hamilton Anxiety Scale
      (HAM-A) to assess the severity of the condition. Depending on the outcome of the diagnostic
      interview, participants will be offered two different courses of treatment:

      Treatment course I: Psychiatric treatment for clinical cases Individuals diagnosed with a
      mental disorder according to the PSE, and with HAM-D score ≥ 18 or HAM-A score ≥ 20, will be
      referred to psychiatric treatment in an outpatient specialized clinic for affective disorders
      at Aalborg Psychiatric Hospital. The treatment will follow standard treatment procedures for
      psychiatric outpatients with diagnoses of depression and anxiety. Treatment is performed by
      trained clinicians (psychiatrists, psychologists and nurses) employed at the Clinic for
      Affective Disorders. The course of treatment includes medical consultations as well as
      psychotherapeutic sessions and treatment will continue until remission is achieved.

      Treatment course II: Preventive treatment for subclinical cases Individuals assessed with
      subclinical conditions of depression or anxiety, defined as a HAM-D score of 13-17 or a HAM-A
      score of 15-19, are offered preventive treatment. This course of treatment consists of eight
      sessions of cognitive behavioral therapy (CBT) conducted by clinical psychologists at Aalborg
      Psychiatric Hospital. During the sessions, the therapeutic focus is on stress-reduction and
      resilience.

      Statistical analysis The primary analysis are carried out by counting the number of clinical
      and subclinical cases identified from the early identification procedure. Secondly, the
      investigators will perform a descriptive analysis with the study population allocated into
      four groups: clinical cases, subclinical cases, untreated cases and healthy subjects. Groups
      will be compared at baseline (T1) on demography, work-related characteristics and the three
      outcome measures Global Severity Index, Depression and Anxiety.

      To analyze the effect of both treatments, the investigators will use mixed effects linear
      regression using random intercept and with participants nested inside the companies. A
      p-value < 0.05 was considered statistically significant.

      Ethics Information about the study are initially provided to the workplace management and the
      health and safety representatives and subsequently to all employees at joint open meetings.

      It is emphasized that the study is voluntary at all levels. Written participant information
      will accompany all questionnaires. The return of the questionnaires will be considered as
      acceptance of participation in the questionnaire part. Written informed consent will be
      obtained from all participants involved in diagnostic interview and treatment. The employees
      are guaranteed complete anonymity in relation to their workplace and company management. The
      study are approved by the Danish Data Protection Agency (j. 2008-58-0028). The study was
      presented to the Danish Scientific Ethics Committee (N-20070016), but the need for approval
      was waived due to the nature of the study.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Change in Severity of Psychopathological symptoms
time frame: Measured at baseline and 6 and 12 month follow-up
description: The change in severity of psychopathological symptoms are measured with the Symptom Checklist 90, revised (SCL-90-R) that is a psychiatric self-report inventory with high reliability and validity to measure overall psychological distress and to detect changes.
arm group label: Clinical cases of Mental Disorder
arm group type: Other
description: The group of individuals identified with a clinical mental disorder on the basis of the diagnostic interviews This group will be assigned to Standard Psychiatric Treatment
arm group label: Subclinical cases of Mental Disorder
arm group type: Other
description: The group of individuals identified with a sub-clinical mental condition on the basis of the diagnostic interviews This group will be assigned to Preventive Psychological Treatment
intervention type: Behavioral
intervention name: Standard Psychiatric Treatment
description: Standard psychiatric treatment is offered individuals identified with a clinical mental disorder. Treatment will follow golden standard treatment in the psychiatric clinic, meaning a combination of therapy and psychopharmacological treatment.
arm group label: Clinical cases of Mental Disorder
intervention type: Behavioral
intervention name: Preventive Psychological Treatment
description: Preventive Psychological Treatment is offered individuals identified with a sub-clinical mental condition. Treatment consists of 8 sessions of cognitive-behavioural therapy.
arm group label: Subclinical cases of Mental Disorder
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Aalborg Psychiatric Hospital
investigator full name: Helle Østermark Sørensen
investigator title: MHSc, Research Nurse
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No