<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/NCT04450238</url>
  </required_header>
  <id_info>
    <org_study_id>2017-387</org_study_id>
    <nct_id>NCT04450238</nct_id>
  </id_info>
  <brief_title>The Dual Factor Model of Mental Health in Inpatients</brief_title>
  <official_title>The Dual Factor Model of Mental Health: A Longitudinal Study in Inpatients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stillachhaus Privatklinik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ruhr University of Bochum</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>
      The Dual Factor Model of mental health (DFM; Greensporn &amp; Saklofske, 2001) postulates that&#xD;
      mental health consists of two at least partially unrelated factors, the experience or absence&#xD;
      of psycho-pathological symptoms (i.e. depressive symptoms) and the experience or absence of&#xD;
      positive mental health (i.e. life satisfaction, meaningfulness). Both factors contribute to&#xD;
      an individual's well-being and mental health.The DFM has been used as a framework to describe&#xD;
      and evaluate participants' mental health in different settings in cross-sectional and&#xD;
      longitudinal designs mostly outside of clinical settings. Psychological Interventions, such&#xD;
      as cognitive-behavioral therapy are widely studied concerning their reduction of&#xD;
      psycho-pathological symptoms. However, little is known about the effect of psychological&#xD;
      interventions on the second factor (positive mental health) of the DFM. This is especially&#xD;
      important, because the latter has been shown to contribute significantly to subjective&#xD;
      well-being and to reduce the risk of suicidal intentions and behavior.&#xD;
&#xD;
      Primary, the authors aim to investigate the DFM in an inpatient sample over the course of&#xD;
      time (pre-treatment, post-treatment, 6 and 12 months after discharge). Secondly, they aim to&#xD;
      investigate the relationship between positive mental health and suicidal ideation over the&#xD;
      course of time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be divided into four groups according to the DFM over the course of time:&#xD;
&#xD;
        1. unhappy: high psychopathology and low positive mental health; depression and/or anxiety&#xD;
           scores above published cut -offs and positive mental health scores under published cut&#xD;
           offs.&#xD;
&#xD;
        2. symptomatic but content: high psychopathology and high positive mental health;&#xD;
           depression and/or anxiety scores above published cut -offs and normal to high positive&#xD;
           mental health scores&#xD;
&#xD;
        3. vulnerable: low psychopathology and low positive mental health; depression and/or&#xD;
           anxiety scores under published cut -offs and positive mental health scores under&#xD;
           published cut offs&#xD;
&#xD;
        4. Complete mental health: low psychopathology and high positive mental health; depression&#xD;
           and/or anxiety scores under published cut -offs normal to high positive mental health&#xD;
           scores.&#xD;
&#xD;
      The authors will then depict the movements of patients through these groups graphically and&#xD;
      use regression analyses to check for differences according to age, diagnosis and gender.&#xD;
&#xD;
      Towards the second aim they will use regression analyses to investigate the protective effect&#xD;
      of positive mental health on suicidal ideation or behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Actual">November 14, 2022</completion_date>
  <primary_completion_date type="Actual">November 14, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)</measure>
    <time_frame>In the first 3 days of treatment</time_frame>
    <description>Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)</measure>
    <time_frame>In the last three days of treatment</time_frame>
    <description>Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive mental health scale (PMH; Lukat et al., 2016)</measure>
    <time_frame>In the first 3 days of treatment</time_frame>
    <description>Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive mental health scale (PMH; Lukat et al., 2016)</measure>
    <time_frame>In the last three days of treatment</time_frame>
    <description>Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive mental health scale (PMH; Lukat et al., 2016)</measure>
    <time_frame>6 months discharge</time_frame>
    <description>Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive mental health scale (PMH; Lukat et al., 2016)</measure>
    <time_frame>12 months discharge</time_frame>
    <description>Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).</measure>
    <time_frame>In the first 3 days of treatment</time_frame>
    <description>Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).</measure>
    <time_frame>In the last three days of treatment</time_frame>
    <description>Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1552</enrollment>
  <condition>Psychological Disease</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>All participants are inpatients at the clinic &quot;Stillachhaus&quot; in Germany. They are receiving treatment for a variety of psychological disoders, mostly depressive disoders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine care inpatient treatment</intervention_name>
    <description>All participants are receiving inpatient treatment consisting of a variety of psychological interventions such as cognitive-behavioral therapy, third-wave interventions, psycho-education and in some cases medication.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients at Stillachhaus Privatklinik fill out the questionnaires prior and post&#xD;
        treatment as part of their routine assessment. They are invited to fill out the same&#xD;
        measures 6 and 12 months after discharge voluntarily to support the long-term evaluation of&#xD;
        their treatment. They have all given written informed consent to use their data for&#xD;
        publication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -inpatients at the Stiilachaus Privatklinik&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -None&#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>Juergen Margraf, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Ruhr-University Bochum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stillachhaus Privatklinik</name>
      <address>
        <city>Oberstdorf</city>
        <state>Bavaria</state>
        <zip>87561</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Ruth von Brachel</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dual Factor Model</keyword>
  <keyword>Positive mental health</keyword>
  <keyword>Suicidal ideation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Since we do not have written consent to publish the data we will refrain from making it publicly available.</ipd_description>
  </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/NCT04450238
org study id: 2017-387
nct id: NCT04450238
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Dual Factor Model of mental health (DFM; Greensporn & Saklofske, 2001) postulates that
      mental health consists of two at least partially unrelated factors, the experience or absence
      of psycho-pathological symptoms (i.e. depressive symptoms) and the experience or absence of
      positive mental health (i.e. life satisfaction, meaningfulness). Both factors contribute to
      an individual's well-being and mental health.The DFM has been used as a framework to describe
      and evaluate participants' mental health in different settings in cross-sectional and
      longitudinal designs mostly outside of clinical settings. Psychological Interventions, such
      as cognitive-behavioral therapy are widely studied concerning their reduction of
      psycho-pathological symptoms. However, little is known about the effect of psychological
      interventions on the second factor (positive mental health) of the DFM. This is especially
      important, because the latter has been shown to contribute significantly to subjective
      well-being and to reduce the risk of suicidal intentions and behavior.

      Primary, the authors aim to investigate the DFM in an inpatient sample over the course of
      time (pre-treatment, post-treatment, 6 and 12 months after discharge). Secondly, they aim to
      investigate the relationship between positive mental health and suicidal ideation over the
      course of time.
Participants will be divided into four groups according to the DFM over the course of time:

        1. unhappy: high psychopathology and low positive mental health; depression and/or anxiety
           scores above published cut -offs and positive mental health scores under published cut
           offs.

        2. symptomatic but content: high psychopathology and high positive mental health;
           depression and/or anxiety scores above published cut -offs and normal to high positive
           mental health scores

        3. vulnerable: low psychopathology and low positive mental health; depression and/or
           anxiety scores under published cut -offs and positive mental health scores under
           published cut offs

        4. Complete mental health: low psychopathology and high positive mental health; depression
           and/or anxiety scores under published cut -offs normal to high positive mental health
           scores.

      The authors will then depict the movements of patients through these groups graphically and
      use regression analyses to check for differences according to age, diagnosis and gender.

      Towards the second aim they will use regression analyses to investigate the protective effect
      of positive mental health on suicidal ideation or behavior.
observational model: Cohort
time perspective: Prospective
measure: Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
time frame: In the first 3 days of treatment
description: Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
measure: Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
time frame: In the last three days of treatment
description: Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
measure: Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
time frame: 6 months after discharge
description: Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
measure: Depression Anxiety Stress Scale-21 (DASS-21; Nilges et al., 2016)
time frame: 12 months after discharge
description: Measures depression, anxiety and stress with 21 items. Scores range from 0-63 with higher scores indicating more severe anxiety, depression and stress.
measure: Positive mental health scale (PMH; Lukat et al., 2016)
time frame: In the first 3 days of treatment
description: Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health.
measure: Positive mental health scale (PMH; Lukat et al., 2016)
time frame: In the last three days of treatment
description: Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health
measure: Positive mental health scale (PMH; Lukat et al., 2016)
time frame: 6 months discharge
description: Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health
measure: Positive mental health scale (PMH; Lukat et al., 2016)
time frame: 12 months discharge
description: Measures positive psychological functioning with 9 items. Scores range from 0-27 with higher scores indicating more positive mental health.
measure: Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
time frame: In the first 3 days of treatment
description: Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
measure: Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
time frame: In the last three days of treatment
description: Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
measure: Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
time frame: 6 months after discharge
description: Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
measure: Suicidal Behavior Questionnaire (SBQ; Osman et al., 2001) ).
time frame: 12 months after discharge
description: Assesses past and current suicidal ideation and behavior. Scores range from 3-18 with higher scores indicating a higher risk for suicidal behavior.
arm group label: Study Group
description: All participants are inpatients at the clinic "Stillachhaus" in Germany. They are receiving treatment for a variety of psychological disoders, mostly depressive disoders.
intervention type: Behavioral
intervention name: Routine care inpatient treatment
description: All participants are receiving inpatient treatment consisting of a variety of psychological interventions such as cognitive-behavioral therapy, third-wave interventions, psycho-education and in some cases medication.
arm group label: Study Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juergen Margraf, Prof.
role: Study Director
affiliation: Ruhr-University Bochum
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Ruth von Brachel
investigator title: Principal Investigator
mesh term: Depression
sharing ipd: No
ipd description: Since we do not have written consent to publish the data we will refrain from making it publicly available.