xml: <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/NCT06012981</url>
    </required_header>
    <id_info>
      <org_study_id>280468</org_study_id>
      <nct_id>NCT06012981</nct_id>
    </id_info>
    <brief_title>Psychological Treatment in Psychiatric Inpatient Care</brief_title>
    <official_title>Psychological Treatment in Psychiatric Inpatient Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uppsala University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uppsala University</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>
        This study aims to investigate the effect of a brief psychotherapeutic treatment intervention&#xD;
        based on ACT, aimed specifically at the vulnerable group of patients in psychiatric 24-hour&#xD;
        care treated according to LPT. The study aims to investigate whether a brief number of&#xD;
        therapeutic sessions according to ACT during inpatient care produce positive effects on&#xD;
        personally relevant life areas for a diagnostically mixed group of patients in a psychiatric&#xD;
        intensive care unit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single-case experimental design.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Personal Questionnaire</measure>
      <time_frame>Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session</time_frame>
      <description>Scores range from 1-4 per item (number of items might differ between patients as the measure is individually constructed. Higher scores correspond to worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Bull's Eye Values Survey</measure>
      <time_frame>Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session</time_frame>
      <description>The score ranges from 0-28, higher scores corresponding to better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PHQ-9</measure>
      <time_frame>Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session</time_frame>
      <description>The score ranges from 0-27, higher scores corresponding to worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in GAD-7</measure>
      <time_frame>Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session</time_frame>
      <description>The score ranges from 0-21, higher scores corresponding to worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Psy-flex</measure>
      <time_frame>Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session</time_frame>
      <description>The score ranges from 6-30, higher scores corresponding to better outcome.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Compulsory Psychiatric Care Act</condition>
    <condition>Psychosis</condition>
    <condition>Acceptance &amp; Commitment Therapy</condition>
    <condition>Psychiatric Hospitalization</condition>
    <condition>Psychiatric Disorder</condition>
    <arm_group>
      <arm_group_label>Acceptance &amp; Commitment Therapy (ACT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ACT</intervention_name>
      <description>The treatment is based on a variant of CBT, as briefly referred to before, ACT. In short, the treatment consists of identifying central and important areas of life, and how to approach these even though you are also struggling with persistent and challenging problems. In this study, the treatment intervention is flexibly constructed, focusing on several central principles based on ACT. These can be applied during one or numerous sessions.&#xD;
  The intervention is a flexible application of clinical functional analysis, as well as a couple of selected interventions which, in terms of experience and in previous studies, have been shown to work well for the current group (24-hour psychiatric patients with complex problems) and which are individually adaptable to the nature of the problem and degree.</description>
      <arm_group_label>Acceptance &amp; Commitment Therapy (ACT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old or older.&#xD;
  &#xD;
            -  Treated according to the compulsory psychiatric care act.&#xD;
  &#xD;
            -  Meet the criterion of informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack the cognitive ability to acquire the treatment intervention, such as impaired&#xD;
               attention, memory, logic and reasoning, and also auditory and visual processing. This&#xD;
               will be based on a clinical assessment by the ward team, including the attending&#xD;
               psychiatrist and a clinical psychologist.&#xD;
  &#xD;
            -  Ongoing psychological treatment parallel to the admission.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kent Nilsson, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Uppsala University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mårten J Tyrberg, PhD</last_name>
      <phone>+4621174373</phone>
      <email>marten.tyrberg@regionvastmanland.se</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital of Västmanland, Västerås</name>
        <address>
          <city>Västerås</city>
          <state>Västmanland</state>
          <zip>72189</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mårten Tyrberg, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uppsala University</investigator_affiliation>
      <investigator_full_name>Marten Tyrberg</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Problem Behavior</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012981
  org study id: 280468
  nct id: NCT06012981
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to investigate the effect of a brief psychotherapeutic treatment intervention
        based on ACT, aimed specifically at the vulnerable group of patients in psychiatric 24-hour
        care treated according to LPT. The study aims to investigate whether a brief number of
        therapeutic sessions according to ACT during inpatient care produce positive effects on
        personally relevant life areas for a diagnostically mixed group of patients in a psychiatric
        intensive care unit.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single-case experimental design.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Personal Questionnaire
  time frame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
  description: Scores range from 1-4 per item (number of items might differ between patients as the measure is individually constructed. Higher scores correspond to worse outcome.
  measure: Change in Bull's Eye Values Survey
  time frame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
  description: The score ranges from 0-28, higher scores corresponding to better outcome.
  measure: Change in PHQ-9
  time frame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
  description: The score ranges from 0-27, higher scores corresponding to worse outcome.
  measure: Change in GAD-7
  time frame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
  description: The score ranges from 0-21, higher scores corresponding to worse outcome.
  measure: Change in Psy-flex
  time frame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
  description: The score ranges from 6-30, higher scores corresponding to better outcome.
  arm group label: Acceptance & Commitment Therapy (ACT)
  arm group type: Experimental
  description: Psyhotherapy based on principles of functional analysis, behavioral activation, and experiential avoidance.
  intervention type: Behavioral
  intervention name: ACT
  description: The treatment is based on a variant of CBT, as briefly referred to before, ACT. In short, the treatment consists of identifying central and important areas of life, and how to approach these even though you are also struggling with persistent and challenging problems. In this study, the treatment intervention is flexibly constructed, focusing on several central principles based on ACT. These can be applied during one or numerous sessions.
  The intervention is a flexible application of clinical functional analysis, as well as a couple of selected interventions which, in terms of experience and in previous studies, have been shown to work well for the current group (24-hour psychiatric patients with complex problems) and which are individually adaptable to the nature of the problem and degree.
  arm group label: Acceptance & Commitment Therapy (ACT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kent Nilsson, Professor
  role: Study Director
  affiliation: Uppsala University
  last name: Mårten J Tyrberg, PhD
  phone: +4621174373
  email: marten.tyrberg@regionvastmanland.se
  facility: 
  status: Recruiting
  contact: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Uppsala University
  investigator full name: Marten Tyrberg
  investigator title: Principal Investigator
  mesh term: Mental Disorders
  mesh term: Problem Behavior
  sharing ipd: No