<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/NCT04461548</url>
  </required_header>
  <id_info>
    <org_study_id>Micro_expect_compass</org_study_id>
    <nct_id>NCT04461548</nct_id>
  </id_info>
  <brief_title>Micro-interventions Aiming to Optimize Expectations or Self-compassion to Improve Well-being/Reduce Stress and Their Differential Effects</brief_title>
  <official_title>Micro-interventions Aiming to Optimize Expectations or Self-compassiong and Their Differential Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philipps University Marburg Medical Center</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 study's aim is to determine whether brief interventions (micro-interventions) aiming to&#xD;
      optimize expectations or enhancing feelings of self-compassion are able to improve&#xD;
      well-being/reduce perceived stress in comparison to an active control group in an&#xD;
      online-study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we use a pre-post-test design to compare the effects of the (classic) best&#xD;
      possible self intervention vs. the best possible self intervention (including ways on how to&#xD;
      reach the imagined best possible future) vs. a self-compassion intervention vs. an active&#xD;
      control group. We are interested in the differential effects and examine several moderators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2020</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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in perceived stress ratings</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>Participants are asked to rate how stressed they feel at the moment at two time points (baseline and the intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).&#xD;
e.g.Lesage, F.-X., Berjot, S., &amp; Deschamps, F. (2012). Clinical stress assessment using a visual ana-logue scale. Occupational Medicine, 62(8), 600-605. https://doi.org/10.1093/occmed/kqs140</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in perceived (stress) burden ratings (resulting from perceived stress)</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>Participants are asked to rate how burdened they feel at the moment at two time points (baseline and the intervention) due to the experienced stress on a questionnaire (VAS: item ranges from 0 (not at all) - 100 (very much). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). Indirect/opposite measure of well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emotions (PANAS)</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).&#xD;
Krohne, H.W., Egloff, B., Kohlmann, C.W., &amp; Tausch, A. (1996). Experiments with a German version of the &quot;Positive and Negative Affect Schedule (PANAS). Diagnostica, 42, 139-156.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in state optimism ratings</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>State Optimism measure (SOM), 7 items (each item 1(strongly disagree)-5(strongly agree)). Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate). Millstein, R. A., Chung, W. J., Hoeppner, B. B., Boehm, J. K., Legler, S. R., Mastromauro, C. A., &amp; Huffman, J. C. (2019). Development of the State Optimism Measure. General hospital psychiatry, 58, 83-93</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in state self-compassion</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>Change in state self-compassion (SCS-state), 16 items (each item 1(strongly disagree) - 5 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).&#xD;
Breines, J. G., &amp; Chen, S. (2013). Activating the inner caregiver: The role of support-giving schemas in increasing state self-compassion. Journal of Experimental Social Psychology, 49(1), 58-64. https://doi.org/10.1016/j.jesp.2012.07.015</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction ratings with the respective intervention</measure>
    <time_frame>Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)</time_frame>
    <description>e.g. &quot;I was satisfied with the intervention&quot; or &quot;I feel like I had a benefit from this intervention&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratings directly assessing the perceived change due to the intervention</measure>
    <time_frame>Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)</time_frame>
    <description>e.g. &quot;The intervention reduced my perceived stress&quot;, &quot;The intervention increased my feeling of being able to influence things&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived self-efficacy (expectations)</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>Change in perceived self-efficacy (SWE), 10 items (each item (1(not at all) - 4(exactly)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).&#xD;
SchwarzerR&amp; Jerusalem M. Generalized Self---Efficacy scale. In J. Weinman, S. Wright, &amp;M. Johnston, Measures in health psychology: A user's portfolio. Causal andcontrol beliefs (pp. 35---37). 1995. Windsor, England: NFER---NELSON.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety and depression state (STADI)</measure>
    <time_frame>Change from pre (baseline) to post scores (approx. 30 minutes later)</time_frame>
    <description>Change in anxiety and depression state (STADI), 20 items (each item 1(strongly disagree) - 4 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).&#xD;
Laux, L., Hock, M., Bergner-Köther, R., Hodapp, V., &amp; Renner, K. H. (2013). The State-Trait-Anxiety-Depression-Inventory-Manual. Göttingen, Germany: Hogrefe.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">179</enrollment>
  <condition>no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing)</condition>
  <arm_group>
    <arm_group_label>Experimental group 1: Best Possible Self</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to think and write about their best possible future self and to imagine this positive future subsequently.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group 2: Best Possible Self + next steps</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to think and write about their best possible future self and what the next steps could be to reach that best possible future. Subsequently, participants are asked to imagine this positive future.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group 3: Self-compassion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to think and write about a self-compassion exercise and to imagine this content subsequently.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are asked to think and write about a neutral task that is comparable to the experimental groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Thinking, writing and imagining</intervention_name>
    <description>All participants are asked to take some time to think and write about the content of the respective intervention group. After the writing exercise (approx. 15-20 min) participants are asked to imagine that content for about 5 minutes.</description>
    <arm_group_label>Active control group</arm_group_label>
    <arm_group_label>Experimental group 1: Best Possible Self</arm_group_label>
    <arm_group_label>Experimental group 2: Best Possible Self + next steps</arm_group_label>
    <arm_group_label>Experimental group 3: Self-compassion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fluent in German language&#xD;
&#xD;
          -  access to a computer/tablet/smartphone with audio output/headphones&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not willing to take part in an online-intervention (duration: 60 minutes)&#xD;
&#xD;
          -  no access to a computer/tablet/smartphone with audio output/headphones&#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>
  <location>
    <facility>
      <name>Philipps University Marburg</name>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35032</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Winfried Rief, Professor</last_name>
      <phone>+49 6421 28 23657</phone>
      <email>rief@staff.uni-marburg.de</email>
    </contact>
    <contact_backup>
      <last_name>Stefan Salzmann, PhD</last_name>
      <phone>+49 6421-2823350</phone>
      <email>stefan.salzmann@staff.uni-marburg.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04461548
org study id: Micro_expect_compass
nct id: NCT04461548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study's aim is to determine whether brief interventions (micro-interventions) aiming to
      optimize expectations or enhancing feelings of self-compassion are able to improve
      well-being/reduce perceived stress in comparison to an active control group in an
      online-study
In this study we use a pre-post-test design to compare the effects of the (classic) best
      possible self intervention vs. the best possible self intervention (including ways on how to
      reach the imagined best possible future) vs. a self-compassion intervention vs. an active
      control group. We are interested in the differential effects and examine several moderators.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in perceived stress ratings
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: Participants are asked to rate how stressed they feel at the moment at two time points (baseline and the intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
e.g.Lesage, F.-X., Berjot, S., & Deschamps, F. (2012). Clinical stress assessment using a visual ana-logue scale. Occupational Medicine, 62(8), 600-605. https://doi.org/10.1093/occmed/kqs140
measure: Change in perceived (stress) burden ratings (resulting from perceived stress)
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: Participants are asked to rate how burdened they feel at the moment at two time points (baseline and the intervention) due to the experienced stress on a questionnaire (VAS: item ranges from 0 (not at all) - 100 (very much). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). Indirect/opposite measure of well-being.
measure: Change in emotions (PANAS)
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).
Krohne, H.W., Egloff, B., Kohlmann, C.W., & Tausch, A. (1996). Experiments with a German version of the "Positive and Negative Affect Schedule (PANAS). Diagnostica, 42, 139-156.
measure: Change in state optimism ratings
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: State Optimism measure (SOM), 7 items (each item 1(strongly disagree)-5(strongly agree)). Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate). Millstein, R. A., Chung, W. J., Hoeppner, B. B., Boehm, J. K., Legler, S. R., Mastromauro, C. A., & Huffman, J. C. (2019). Development of the State Optimism Measure. General hospital psychiatry, 58, 83-93
measure: Change in state self-compassion
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: Change in state self-compassion (SCS-state), 16 items (each item 1(strongly disagree) - 5 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
Breines, J. G., & Chen, S. (2013). Activating the inner caregiver: The role of support-giving schemas in increasing state self-compassion. Journal of Experimental Social Psychology, 49(1), 58-64. https://doi.org/10.1016/j.jesp.2012.07.015
measure: Satisfaction ratings with the respective intervention
time frame: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
description: e.g. "I was satisfied with the intervention" or "I feel like I had a benefit from this intervention"
measure: Ratings directly assessing the perceived change due to the intervention
time frame: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
description: e.g. "The intervention reduced my perceived stress", "The intervention increased my feeling of being able to influence things"
measure: Change in perceived self-efficacy (expectations)
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: Change in perceived self-efficacy (SWE), 10 items (each item (1(not at all) - 4(exactly)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
SchwarzerR& Jerusalem M. Generalized Self---Efficacy scale. In J. Weinman, S. Wright, &M. Johnston, Measures in health psychology: A user's portfolio. Causal andcontrol beliefs (pp. 35---37). 1995. Windsor, England: NFER---NELSON.
measure: Change in anxiety and depression state (STADI)
time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
description: Change in anxiety and depression state (STADI), 20 items (each item 1(strongly disagree) - 4 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
Laux, L., Hock, M., Bergner-Köther, R., Hodapp, V., & Renner, K. H. (2013). The State-Trait-Anxiety-Depression-Inventory-Manual. Göttingen, Germany: Hogrefe.
arm group label: Experimental group 1: Best Possible Self
arm group type: Experimental
description: Participants are asked to think and write about their best possible future self and to imagine this positive future subsequently.
arm group label: Experimental group 2: Best Possible Self + next steps
arm group type: Experimental
description: Participants are asked to think and write about their best possible future self and what the next steps could be to reach that best possible future. Subsequently, participants are asked to imagine this positive future.
arm group label: Experimental group 3: Self-compassion
arm group type: Experimental
description: Participants are asked to think and write about a self-compassion exercise and to imagine this content subsequently.
arm group label: Active control group
arm group type: Active Comparator
description: Participants are asked to think and write about a neutral task that is comparable to the experimental groups.
intervention type: Behavioral
intervention name: Thinking, writing and imagining
description: All participants are asked to take some time to think and write about the content of the respective intervention group. After the writing exercise (approx. 15-20 min) participants are asked to imagine that content for about 5 minutes.
arm group label: Active control group
arm group label: Experimental group 1: Best Possible Self
arm group label: Experimental group 2: Best Possible Self + next steps
arm group label: Experimental group 3: Self-compassion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
sharing ipd: Undecided