<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/NCT03759444</url>
  </required_header>
  <id_info>
    <org_study_id>PBF-31/16</org_study_id>
    <nct_id>NCT03759444</nct_id>
  </id_info>
  <brief_title>Perception of Time by Individuals With Eating Disorders</brief_title>
  <official_title>Stuck in Painful Time: Perception of Time by Individuals With Eating Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malgorzata Starzomska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardinal Stefan Wyszynski 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>
      The objective of the study was to determine how patients with eating disorders perceive time,&#xD;
      and in particular whether their experience of time differs from that of healthy individuals.&#xD;
      Another goal was to examine the relationship between the mood of the subjects and their time&#xD;
      perspective. The subjects were 30 women with eating disorders and 30 age-matched healthy&#xD;
      female controls. The three measures applied were: the Time Metaphors Questionnaire by&#xD;
      Sobol-Kwapinska, the Time Perspective Inventory by Zimbardo, and the UWIST Mood Adjective&#xD;
      Checklist (UMACL) by Matthews et al.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study was to determine how individuals with eating disorders perceive&#xD;
      time, and in particular whether their experience of time differs from that of healthy&#xD;
      persons. Another aim was to investigate the relationship between the mood of the subjects and&#xD;
      their time perception as well as determine a variable moderating that relationship.&#xD;
&#xD;
      First, it was expected that eating-disordered patients experience time as a rather aversive&#xD;
      and unfriendly force marked with chaos and void, in contrast to healthy subjects, who were&#xD;
      predicted to treat it as something more friendly, appreciating its subtleties and the&#xD;
      significance of the moment (Hypothesis 1).&#xD;
&#xD;
      Moreover, it was expected that individuals with eating disorders would exhibit a more&#xD;
      negative temporal orientation, whether past or present, as compared to healthy controls, who&#xD;
      would reveal more positive past, present, or future orientations (Hypothesis 2).&#xD;
&#xD;
      Finally, it was predicted that eating disorders moderate the relationship between mood and&#xD;
      time perception (Hypothesis 3).&#xD;
&#xD;
      The study encompassed 30 women with eating disorders (19 patients with anorexia nervosa and&#xD;
      11 patients with bulimia nervosa) and 30 age-matched normal healthy controls. The clinical&#xD;
      group consisted of patients of the residential eating disorder therapeutic center &quot;Drzewo&#xD;
      zycia&quot; in Malawa as well as some outpatient clinics in Poland; some of the patients were not&#xD;
      being actively treated at the time of the study. The controls included psychology students&#xD;
      from two Polish universities (the Cardinal Stefan Wyszynski University and the University of&#xD;
      Finance and Management, both in Warsaw), as well as researchers and educators who volunteered&#xD;
      for the study.&#xD;
&#xD;
      The three measures applied in the study were:&#xD;
&#xD;
        -  The Time Metaphors Questionnaire by Sobol-Kwapinska;&#xD;
&#xD;
        -  Time Perspective Inventory by Zimbardo (Zimbardo &amp; Boyd, 1999; see also Zimbardo &amp; Boyd,&#xD;
           2009);&#xD;
&#xD;
        -  The UWIST Mood Adjective Checklist (UMACL) (Matthews at al.; see also Gorynska, 2005).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Time Metaphors Questionnaire by Sobol-Kwapińska</measure>
    <time_frame>1.05.2014-30.06.2017</time_frame>
    <description>The measure consists of 95 items formulated as metaphors describing ideas eliciting strong emotions. The subjects are asked to rate the items on a scale from 1 to 4, depending on the degree to which a given metaphor is consistent with their perception of time. The items are grouped into 3 scales reflecting positive attitudes to time: Friendly Time (subdivided into two subscales: Constructive Time and Pleasant Time), Significance of the Moment, and Subtle Time, as well as four scales covering negative attitudes to time: Hostile Time (with three subscales: Finiteness of Time, Bitter Time, and Confusion in Time), Rapid Passage of Time, Wild Time, and Empty Time. The questionnaire reveals satisfactory reliability and validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time Perspective Inventory by Zimbardo</measure>
    <time_frame>1.05.2014-30.06.2017</time_frame>
    <description>The measure consists of 56 items which the respondents rate on a 5-point scale ranging from 1 (very uncharacteristic of me) to 5 (very characteristic of me). The questionnaire tests 5 time perspectives: 1) Past-Negative, 2) Past-Positive, 3) Present-Hedonistic, 4) Present-Fatalistic, and 5) Future. The Polish version of this instrument has been reported to have both good reliability and validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transcendental Future Time Perspective Inventory</measure>
    <time_frame>1.05.2014-30.06.2017</time_frame>
    <description>This is a one-dimensional scale that consists of 10 items which the respondents rate on a 5-point scale ranging from 1 (very uncharacteristic of me) to 5 (very characteristic of me). It is used to assess individual attitudes and beliefs regarding the future, immediately following the imagined death of the physical body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The UWIST Mood Adjective Checklist (UMACL) by Matthews et al.</measure>
    <time_frame>1.05.2014-30.06.2017</time_frame>
    <description>The instrument measures mood understood as an affective experience of a duration of at least several minutes; its three scales are Tense Arousal, Energetic Arousal, and Hedonic Tone. The UMACL consists of a list of 29 adjectives which the respondents rate in terms of applicability to their current mood on a four-point scale from definitely yes to definitely not. The reliability and validity of the Polish adaptation has been confirmed.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Feeding and Eating Disorders</condition>
  <arm_group>
    <arm_group_label>women with eating disorders</arm_group_label>
    <description>women with eating disorders (age: M = 26.88; SD = 5.82)&#xD;
The three measures applied in this group were: the Time Metaphors Questionnaire by Sobol-Kwapinska (2007), the Time Perspective Inventory by Zimbardo (1999), and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al. (1990).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy female controls.</arm_group_label>
    <description>healthy female controls (age: M = 24.27; SD = 6.49)&#xD;
The three measures applied in this group were: the Time Metaphors Questionnaire by Sobol-Kwapinska (2007), the Time Perspective Inventory by Zimbardo (1999), and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al. (1990).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>The three questionnaires applied were: the Time Metaphors Questionnaire by Sobol-Kwapinska, the Time Perspective Inventory by Zimbardo, and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al.</description>
    <arm_group_label>healthy female controls.</arm_group_label>
    <arm_group_label>women with eating disorders</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The clinical and control groups did not differ significantly in terms of age (t = 1.64, p =&#xD;
        0.100) or height (t = -0.54, p = 0.590). Obviously, significant differences were found in&#xD;
        terms of weight and BMI (t = -2.93 and t = -3.03, p &lt; 0.01, respectively): women with&#xD;
        eating disorders were much lighter (M = 50.78, SD = 13.05) and had a much lower BMI (M =&#xD;
        18.3, SD = 4.49) than healthy controls (M = 60.43, SD = 12.48, and M = 21.62, SD = 3.98,&#xD;
        respectively). The mean duration of eating disorder was 8.9 years (SD = 5.23).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of eating disorders (anorexia nervosa or bulimia nervosa)&#xD;
&#xD;
          -  Age between 18 and 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosis of other (except eating disorders) mental disorder&#xD;
&#xD;
          -  Age below 18 years and above 40 years&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Malgorzata Starzomska, dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardinal Stefan Wyszynski University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Gorynska E. UMACL Mood Adjective Checklist by G. Matthews, A.G. Chamberlain, D.M. Jones. Pracownia Testow Psychologicznych Polskiego Towarzystwa Psychologicznego, Warszawa, 2005.</citation>
  </results_reference>
  <results_reference>
    <citation>Matthews G, Jones DM, Chamberlain AG. Refining the measurement of mood: the UWIST Mood Adjective Checklist. British Journal of Psychology 81(1): 17-42, 1990.</citation>
  </results_reference>
  <results_reference>
    <citation>Sobol-Kwapinska M. TMQ Time Metaphor Questionnaire: Manual. Pracownia Testow Psychologicznych PTP, Warszawa, 2008.</citation>
  </results_reference>
  <results_reference>
    <citation>Zimbardo P G, Boyd J. The time paradox. PWN, Warszawa, 2009.</citation>
  </results_reference>
  <results_reference>
    <citation>Zimbardo P, Boyd J. Putting time in perspective: a valid, reliable individual differences metric. Journal of Personality and Social Psychology 77(6): 1271-1288, 1999.</citation>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cardinal Stefan Wyszynski University</investigator_affiliation>
    <investigator_full_name>Malgorzata Starzomska</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Perception of time</keyword>
  <keyword>Eating disorders</keyword>
  <keyword>Ego-syntonicity</keyword>
  <keyword>Existential suffering</keyword>
  <keyword>Psychotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating 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/NCT03759444
org study id: PBF-31/16
nct id: NCT03759444
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study was to determine how patients with eating disorders perceive time,
      and in particular whether their experience of time differs from that of healthy individuals.
      Another goal was to examine the relationship between the mood of the subjects and their time
      perspective. The subjects were 30 women with eating disorders and 30 age-matched healthy
      female controls. The three measures applied were: the Time Metaphors Questionnaire by
      Sobol-Kwapinska, the Time Perspective Inventory by Zimbardo, and the UWIST Mood Adjective
      Checklist (UMACL) by Matthews et al.
The objective of the study was to determine how individuals with eating disorders perceive
      time, and in particular whether their experience of time differs from that of healthy
      persons. Another aim was to investigate the relationship between the mood of the subjects and
      their time perception as well as determine a variable moderating that relationship.

      First, it was expected that eating-disordered patients experience time as a rather aversive
      and unfriendly force marked with chaos and void, in contrast to healthy subjects, who were
      predicted to treat it as something more friendly, appreciating its subtleties and the
      significance of the moment (Hypothesis 1).

      Moreover, it was expected that individuals with eating disorders would exhibit a more
      negative temporal orientation, whether past or present, as compared to healthy controls, who
      would reveal more positive past, present, or future orientations (Hypothesis 2).

      Finally, it was predicted that eating disorders moderate the relationship between mood and
      time perception (Hypothesis 3).

      The study encompassed 30 women with eating disorders (19 patients with anorexia nervosa and
      11 patients with bulimia nervosa) and 30 age-matched normal healthy controls. The clinical
      group consisted of patients of the residential eating disorder therapeutic center "Drzewo
      zycia" in Malawa as well as some outpatient clinics in Poland; some of the patients were not
      being actively treated at the time of the study. The controls included psychology students
      from two Polish universities (the Cardinal Stefan Wyszynski University and the University of
      Finance and Management, both in Warsaw), as well as researchers and educators who volunteered
      for the study.

      The three measures applied in the study were:

        -  The Time Metaphors Questionnaire by Sobol-Kwapinska;

        -  Time Perspective Inventory by Zimbardo (Zimbardo & Boyd, 1999; see also Zimbardo & Boyd,
           2009);

        -  The UWIST Mood Adjective Checklist (UMACL) (Matthews at al.; see also Gorynska, 2005).
observational model: Case-Only
time perspective: Retrospective
measure: The Time Metaphors Questionnaire by Sobol-Kwapińska
time frame: 1.05.2014-30.06.2017
description: The measure consists of 95 items formulated as metaphors describing ideas eliciting strong emotions. The subjects are asked to rate the items on a scale from 1 to 4, depending on the degree to which a given metaphor is consistent with their perception of time. The items are grouped into 3 scales reflecting positive attitudes to time: Friendly Time (subdivided into two subscales: Constructive Time and Pleasant Time), Significance of the Moment, and Subtle Time, as well as four scales covering negative attitudes to time: Hostile Time (with three subscales: Finiteness of Time, Bitter Time, and Confusion in Time), Rapid Passage of Time, Wild Time, and Empty Time. The questionnaire reveals satisfactory reliability and validity.
measure: Time Perspective Inventory by Zimbardo
time frame: 1.05.2014-30.06.2017
description: The measure consists of 56 items which the respondents rate on a 5-point scale ranging from 1 (very uncharacteristic of me) to 5 (very characteristic of me). The questionnaire tests 5 time perspectives: 1) Past-Negative, 2) Past-Positive, 3) Present-Hedonistic, 4) Present-Fatalistic, and 5) Future. The Polish version of this instrument has been reported to have both good reliability and validity.
measure: Transcendental Future Time Perspective Inventory
time frame: 1.05.2014-30.06.2017
description: This is a one-dimensional scale that consists of 10 items which the respondents rate on a 5-point scale ranging from 1 (very uncharacteristic of me) to 5 (very characteristic of me). It is used to assess individual attitudes and beliefs regarding the future, immediately following the imagined death of the physical body.
measure: The UWIST Mood Adjective Checklist (UMACL) by Matthews et al.
time frame: 1.05.2014-30.06.2017
description: The instrument measures mood understood as an affective experience of a duration of at least several minutes; its three scales are Tense Arousal, Energetic Arousal, and Hedonic Tone. The UMACL consists of a list of 29 adjectives which the respondents rate in terms of applicability to their current mood on a four-point scale from definitely yes to definitely not. The reliability and validity of the Polish adaptation has been confirmed.
arm group label: women with eating disorders
description: women with eating disorders (age: M = 26.88; SD = 5.82)
The three measures applied in this group were: the Time Metaphors Questionnaire by Sobol-Kwapinska (2007), the Time Perspective Inventory by Zimbardo (1999), and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al. (1990).
arm group label: healthy female controls.
description: healthy female controls (age: M = 24.27; SD = 6.49)
The three measures applied in this group were: the Time Metaphors Questionnaire by Sobol-Kwapinska (2007), the Time Perspective Inventory by Zimbardo (1999), and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al. (1990).
intervention type: Other
intervention name: Questionnaires
description: The three questionnaires applied were: the Time Metaphors Questionnaire by Sobol-Kwapinska, the Time Perspective Inventory by Zimbardo, and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al.
arm group label: healthy female controls.
arm group label: women with eating disorders
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
last name: Malgorzata Starzomska, dr
role: Principal Investigator
affiliation: Cardinal Stefan Wyszynski University
citation: Gorynska E. UMACL Mood Adjective Checklist by G. Matthews, A.G. Chamberlain, D.M. Jones. Pracownia Testow Psychologicznych Polskiego Towarzystwa Psychologicznego, Warszawa, 2005.
citation: Matthews G, Jones DM, Chamberlain AG. Refining the measurement of mood: the UWIST Mood Adjective Checklist. British Journal of Psychology 81(1): 17-42, 1990.
citation: Sobol-Kwapinska M. TMQ Time Metaphor Questionnaire: Manual. Pracownia Testow Psychologicznych PTP, Warszawa, 2008.
citation: Zimbardo P G, Boyd J. The time paradox. PWN, Warszawa, 2009.
citation: Zimbardo P, Boyd J. Putting time in perspective: a valid, reliable individual differences metric. Journal of Personality and Social Psychology 77(6): 1271-1288, 1999.
responsible party type: Sponsor-Investigator
investigator affiliation: Cardinal Stefan Wyszynski University
investigator full name: Malgorzata Starzomska
investigator title: Principal Investigator
mesh term: Feeding and Eating Disorders
sharing ipd: No