<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/NCT03238872</url>
  </required_header>
  <id_info>
    <org_study_id>260659</org_study_id>
    <nct_id>NCT03238872</nct_id>
  </id_info>
  <brief_title>Trial of Prompt Mental Health Care</brief_title>
  <official_title>Randomized Controlled Trial of Prompt Mental Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sussex Partnership NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian Institute of Public Health</source>
  <oversight_info>
    <has_dmc>No</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>
      Anxiety and depression are among the most common mental disorders in the population. Anxiety&#xD;
      and depression have significant consequences at the individual, family and community level,&#xD;
      and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner&#xD;
      annually. The majority of this amount is accounted for by anxiety and depression disorders.&#xD;
      Meanwhile, access to mental health services to treat these disorders is limited. The&#xD;
      proportion of people who do not receive treatment of those who are in need of treatment is&#xD;
      estimated to be over 50%.&#xD;
&#xD;
      Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of&#xD;
      Health commissioned by the Ministry of Health, with the goal of increasing access to&#xD;
      evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of&#xD;
      depression. The treatment offered is cognitive behavioural therapy and should lead to reduced&#xD;
      levels of symptoms of anxiety and depression, improved quality of life and better&#xD;
      employability. PMHC is based on the English program &quot;Improving Access to Psychological&#xD;
      Therapy (IAPT)&quot;, which is established in virtually all health communities in England.&#xD;
&#xD;
      The evaluations of IAPT and PMHC have until now been based on relatively weak research&#xD;
      designs which make it difficult to know to what extent the initiative really has the desired&#xD;
      effect. In this study, PMHC is compared with a control group that receives treatment as usual&#xD;
      (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and&#xD;
      Sandnes). Participants are randomly assigned to either the PMHC or the control group. The&#xD;
      investigators aim to include 1100 clients in the study.&#xD;
&#xD;
      The key objectives of this study are to investigate whether PMHC treatment is more effective&#xD;
      as compared to treatment in the control group with regard to symptoms of anxiety and&#xD;
      depression, work participation, functional status, and mental well-being. Cost-effectiveness&#xD;
      of PMHC is also examined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2015</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery rate</measure>
    <time_frame>Baseline to 6-month follow-up</time_frame>
    <description>Proportion of clients that have recovered based on predefined cut-offs for the Patient Health Questionnaire (PHQ&lt;10) and Generalized Anxiety Disorder scale (GAD&lt;8).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in mean levels of depression and anxiety</measure>
    <time_frame>Baseline to 6-month follow-up</time_frame>
    <description>Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up</measure>
    <time_frame>Baseline to 12-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.</measure>
    <time_frame>Baseline to 24/36-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work participation</measure>
    <time_frame>Baseline to 12-month follow-up</time_frame>
    <description>Increased or maintained work participation at 6 and 12 month follow-up, defined as maintained work participation, new employment or a full or partial return-to-work. Both questionnaire and registry-based data are used for this purpose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status</measure>
    <time_frame>Baseline to 12-month follow-up; for experimental group to 36-month follow-up.</time_frame>
    <description>Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Baseline to 12-month follow-up; for experimental group to 36-month follow-up.</time_frame>
    <description>Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Well-being</measure>
    <time_frame>Baseline to 12-month follow-up; for experimental group to 36-month follow-up.</time_frame>
    <description>Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">774</enrollment>
  <condition>Anxiety</condition>
  <condition>Mild to Moderate Depression</condition>
  <arm_group>
    <arm_group_label>Prompt Mental Health Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clients in the experimental group receive short-term cognitive behavioural therapy in the form of a psycho-educational group course, guided self-help, or individual face-to-face therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clients in the comparison group are offered treatment as usual from their general practitioner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioural Therapy</intervention_name>
    <arm_group_label>Prompt Mental Health Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PHQ-9/GAD-7 scores above cut off Level&#xD;
&#xD;
          -  Being above 18 years of age and a resident in the pilot sites&#xD;
&#xD;
          -  Basic verbal and oral Norwegian proficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Entitled to secondary care services due to eating disorder, suicide risk, bipolar&#xD;
             disorder, severe depression, invaliding anxiety, psychotic symptoms, severe substance&#xD;
             abuse, and personality disorder.&#xD;
&#xD;
          -  Two or more previous treatment attempts without effect.&#xD;
&#xD;
          -  Serious physical health problem as prime problem&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Smith, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian Institute of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rask Psykisk Helsehjelp Kristiansand</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rask Psykisk Helsehjelp Sandnes</name>
      <address>
        <city>Sandnes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://www.karger.com/Article/FullText/504453</url>
    <description>Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norwegian Institute of Public Health</investigator_affiliation>
    <investigator_full_name>Robert Smith</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>CBT</keyword>
  <keyword>Outcome monitoring</keyword>
  <keyword>Dissemination</keyword>
  <keyword>Routine services</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT03238872
org study id: 260659
nct id: NCT03238872
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anxiety and depression are among the most common mental disorders in the population. Anxiety
      and depression have significant consequences at the individual, family and community level,
      and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner
      annually. The majority of this amount is accounted for by anxiety and depression disorders.
      Meanwhile, access to mental health services to treat these disorders is limited. The
      proportion of people who do not receive treatment of those who are in need of treatment is
      estimated to be over 50%.

      Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of
      Health commissioned by the Ministry of Health, with the goal of increasing access to
      evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of
      depression. The treatment offered is cognitive behavioural therapy and should lead to reduced
      levels of symptoms of anxiety and depression, improved quality of life and better
      employability. PMHC is based on the English program "Improving Access to Psychological
      Therapy (IAPT)", which is established in virtually all health communities in England.

      The evaluations of IAPT and PMHC have until now been based on relatively weak research
      designs which make it difficult to know to what extent the initiative really has the desired
      effect. In this study, PMHC is compared with a control group that receives treatment as usual
      (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and
      Sandnes). Participants are randomly assigned to either the PMHC or the control group. The
      investigators aim to include 1100 clients in the study.

      The key objectives of this study are to investigate whether PMHC treatment is more effective
      as compared to treatment in the control group with regard to symptoms of anxiety and
      depression, work participation, functional status, and mental well-being. Cost-effectiveness
      of PMHC is also examined.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recovery rate
time frame: Baseline to 6-month follow-up
description: Proportion of clients that have recovered based on predefined cut-offs for the Patient Health Questionnaire (PHQ<10) and Generalized Anxiety Disorder scale (GAD<8).
measure: Changes in mean levels of depression and anxiety
time frame: Baseline to 6-month follow-up
description: Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD
measure: Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up
time frame: Baseline to 12-month follow-up
measure: Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.
time frame: Baseline to 24/36-month follow-up
measure: Work participation
time frame: Baseline to 12-month follow-up
description: Increased or maintained work participation at 6 and 12 month follow-up, defined as maintained work participation, new employment or a full or partial return-to-work. Both questionnaire and registry-based data are used for this purpose.
measure: Functional status
time frame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
description: Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS).
measure: Health-related quality of life
time frame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
description: Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D).
measure: Mental Well-being
time frame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
description: Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).
arm group label: Prompt Mental Health Care
arm group type: Experimental
description: Clients in the experimental group receive short-term cognitive behavioural therapy in the form of a psycho-educational group course, guided self-help, or individual face-to-face therapy.
arm group label: Treatment as usual
arm group type: Active Comparator
description: Clients in the comparison group are offered treatment as usual from their general practitioner.
intervention type: Behavioral
intervention name: Cognitive Behavioural Therapy
arm group label: Prompt Mental Health Care
intervention type: Other
intervention name: Treatment as usual
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Smith, PhD
role: Principal Investigator
affiliation: Norwegian Institute of Public Health
facility: 
facility: 
country: Norway
url: https://www.karger.com/Article/FullText/504453
description: Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial
responsible party type: Principal Investigator
investigator affiliation: Norwegian Institute of Public Health
investigator full name: Robert Smith
investigator title: Researcher
mesh term: Depression