<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/NCT03024853</url>
  </required_header>
  <id_info>
    <org_study_id>H1415802387094</org_study_id>
    <nct_id>NCT03024853</nct_id>
  </id_info>
  <brief_title>Efficacy of Different Versions of the Best Possible Self Intervention</brief_title>
  <official_title>Efficacy of Different Versions of the Best Possible Self Intervention: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to analyze the efficacy of several variations of an already&#xD;
      validated Positive Psychology Intervention (PPI) called Best Possible Self, using Information&#xD;
      and Communication Technologies (ICT) in general population. Participants are randomly&#xD;
      assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS FUTURE&#xD;
      condition, and CONTROL condition (daily activities).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention lasts 7 days. Participants come to the laboratory the first day, they fill up&#xD;
      assessment questionnaires and practice the assigned exercise. Then, they practice the&#xD;
      assigned exercise for 6 more days at home.&#xD;
&#xD;
      The main hypothesis is that all three experimental conditions will enhance wellbeing&#xD;
      comparing to the control condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">March 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Positive and Negative Affect Scale (PANAS; Watson, Clark &amp; Tellegen, 1988; Sandín et al., 1999) from baseline to post-in</measure>
    <time_frame>Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>New General Self-Efficacy Scale (NGSES; Chen, Gully &amp; Eden, 2001)</measure>
    <time_frame>Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Orientation Test (LOT-R; Otero, Luengo, Romero Gómez &amp; Castro, 1998; Scheier, Carver &amp; Bridges, 1994).</measure>
    <time_frame>Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fordyce Happiness Scale (Fordyce, 1988)</measure>
    <time_frame>Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal Satisfaction with Life Scale (TSWLS; Pavot, Diener &amp; Suh, 1998)</measure>
    <time_frame>Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-Concordant Motivation (SCM; Sheldon &amp; Elliot, 1999)</measure>
    <time_frame>Day 1</time_frame>
    <description>This scale measures the intrinsic motivation of participants' when practicing the assigned activity.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>General Population</condition>
  <arm_group>
    <arm_group_label>BPS PAST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants write down about themselves in a past when they displayed their best self. Then, they make a video with this text and a chosen song, watch the video and then they visualize (imagine) the content.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPS PRESENT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants write down about themselves in in the present, focusing on what currently makes the best version of themselves (skills, features...). Then, they make a video with this text and a chosen song, watch the video and then they visualize (imagine) the content.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPS FUTURE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants write down about themselves in the future after everything has gone as well as it possibly could. Then, they make a video with this text and a chosen song, watch the video and then they visualize (imagine) the content.&#xD;
This is the original BPS exercise (already validated in other studies).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants write down the activities they did during the last 24 hours. Then, they visualize (imagine) the content. They practice the visualization exercise for 7 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BPS PAST</intervention_name>
    <arm_group_label>BPS PAST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BPS PRESENT</intervention_name>
    <arm_group_label>BPS PRESENT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BPS FUTURE</intervention_name>
    <arm_group_label>BPS FUTURE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CONTROL</intervention_name>
    <arm_group_label>CONTROL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be 18 years old or older.&#xD;
&#xD;
          -  Participants must be willing to participate in the study.&#xD;
&#xD;
          -  Participants must have computer with Internet access and e-mail address.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To suffer from moderated or severe depression as established by a score of 20 or more&#xD;
             in the Beck Inventory of Depression (BDI-II; Beck, 1996).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa M Baños, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ernestina Etchemendy, Researcher</last_name>
    <role>Study Director</role>
    <affiliation>University of Teruel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alba Carrillo, PhD student</last_name>
    <role>Study Chair</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2.</citation>
    <PMID>21450262</PMID>
  </reference>
  <reference>
    <citation>King L. The Health Benefits of Writing About Life Goals. Personality and Social Psychology Bulletin 27(7): 798-807, 2001.</citation>
  </reference>
  <reference>
    <citation>Sheldon KM, Lyubomirsky S. How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology 1(2): 73-82, 2006.</citation>
  </reference>
  <reference>
    <citation>Peters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: Can imagining a best possible self be used to increase positive future expectancies? The Journal of Positive Psychology 5(3): 204-211, 2010.</citation>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>October 5, 2018</last_update_submitted>
  <last_update_submitted_qc>October 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Rosa María Baños Rivera</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>Best Possible Self</keyword>
  <keyword>Positive Intervention</keyword>
  <keyword>Optimism</keyword>
  <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/NCT03024853
org study id: H1415802387094
nct id: NCT03024853
lead sponsor: 
has dmc: No
The aim of this study is to analyze the efficacy of several variations of an already
      validated Positive Psychology Intervention (PPI) called Best Possible Self, using Information
      and Communication Technologies (ICT) in general population. Participants are randomly
      assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS FUTURE
      condition, and CONTROL condition (daily activities).
Intervention lasts 7 days. Participants come to the laboratory the first day, they fill up
      assessment questionnaires and practice the assigned exercise. Then, they practice the
      assigned exercise for 6 more days at home.

      The main hypothesis is that all three experimental conditions will enhance wellbeing
      comparing to the control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from Positive and Negative Affect Scale (PANAS; Watson, Clark & Tellegen, 1988; Sandín et al., 1999) from baseline to post-in
time frame: Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).
measure: New General Self-Efficacy Scale (NGSES; Chen, Gully & Eden, 2001)
time frame: Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).
measure: Life Orientation Test (LOT-R; Otero, Luengo, Romero Gómez & Castro, 1998; Scheier, Carver & Bridges, 1994).
time frame: Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).
measure: Fordyce Happiness Scale (Fordyce, 1988)
time frame: Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).
measure: Temporal Satisfaction with Life Scale (TSWLS; Pavot, Diener & Suh, 1998)
time frame: Change from pre-intervention to post-intervention (1 week) and follow-up (1 month, 3 months).
measure: Self-Concordant Motivation (SCM; Sheldon & Elliot, 1999)
time frame: Day 1
description: This scale measures the intrinsic motivation of participants' when practicing the assigned activity.
arm group label: BPS PAST
arm group type: Experimental
description: Participants write down about themselves in a past when they displayed their best self. Then, they make a video with this text and a chosen song, watch the video and then they visualize (imagine) the content.
arm group label: BPS PRESENT
arm group type: Experimental
description: Participants write down about themselves in in the present, focusing on what currently makes the best version of themselves (skills, features...). Then, they make a video with this text and a chosen song, watch the video and then they visualize (imagine) the content.
arm group label: BPS FUTURE
arm group type: Experimental
description: Participants write down about themselves in the future after everything has gone as well as it possibly could. Then, they make a video with this text and a chosen song, watch the video and then they visualize (imagine) the content.
This is the original BPS exercise (already validated in other studies).
arm group label: CONTROL
arm group type: Active Comparator
description: Participants write down the activities they did during the last 24 hours. Then, they visualize (imagine) the content. They practice the visualization exercise for 7 consecutive days.
intervention type: Behavioral
intervention name: BPS PAST
arm group label: BPS PAST
intervention type: Behavioral
intervention name: BPS PRESENT
arm group label: BPS PRESENT
intervention type: Behavioral
intervention name: BPS FUTURE
arm group label: BPS FUTURE
intervention type: Behavioral
intervention name: CONTROL
arm group label: CONTROL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa M Baños, Professor
role: Study Director
affiliation: University of Valencia
last name: Ernestina Etchemendy, Researcher
role: Study Director
affiliation: University of Teruel
last name: Alba Carrillo, PhD student
role: Study Chair
affiliation: University of Valencia
facility: 
country: Spain
citation: Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2.
PMID: 21450262
citation: King L. The Health Benefits of Writing About Life Goals. Personality and Social Psychology Bulletin 27(7): 798-807, 2001.
citation: Sheldon KM, Lyubomirsky S. How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology 1(2): 73-82, 2006.
citation: Peters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: Can imagining a best possible self be used to increase positive future expectancies? The Journal of Positive Psychology 5(3): 204-211, 2010.
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Rosa María Baños Rivera
investigator title: Full Professor
sharing ipd: No