<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/NCT03299127</url>
  </required_header>
  <id_info>
    <org_study_id>IR-Phoenix</org_study_id>
    <nct_id>NCT03299127</nct_id>
  </id_info>
  <brief_title>Imagery Rescripting in Depression</brief_title>
  <official_title>A Self-help Manual of Imagery Rescripting Reduces Depressive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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>
      Depression is among the world's leading causes of disability. To fill the existing treatment&#xD;
      gap, psychological online interventions (POIs) and Internet-based treatment, including&#xD;
      bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily&#xD;
      accessible and deemed an initial alternative approach. The present trial aims to evaluate&#xD;
      imagery rescripting. With the help of various techniques, the approach aims to edit negative&#xD;
      memories and rewrite a &quot;happy end&quot;. To the best of our knowledge, imagery rescripting has&#xD;
      never been tested as a self-help intervention. A large sample of patients with primary or&#xD;
      secondary depression (N = 120) will be recruited and randomly allocated to either the&#xD;
      intervention group or a wait-list control group. The intervention group consists of two&#xD;
      subgroups that will receive either a full or brief version of a manual teaching them imagery&#xD;
      rescripting. Participants will be assessed at baseline and six weeks later. A follow-up&#xD;
      assessment will be completed six months later. The primary outcome measure is the Beck&#xD;
      Depression Inventory II.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is among the world's leading causes of disability. Effective pharmacological and&#xD;
      psychotherapeutic treatments exist. However, only a subgroup of individuals with depressive&#xD;
      symptoms receive proper treatment (Kohn, Saxena, Levav, &amp; Saraceno, 2004). To fill the&#xD;
      existing treatment gap (Kazdin, 2017), psychological online interventions (POIs) and&#xD;
      Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly&#xD;
      recommended as they are easily accessible and deemed an initial alternative approach (i.e.,&#xD;
      &quot;foot in the door&quot;) for persons who have reservations about face-to-face psychotherapy.&#xD;
      E-mental health and bilbiotherapeutic interventions have yielded promising results, but there&#xD;
      remains room for improvement as effect sizes are usually in the small to medium range. The&#xD;
      present trial aims to evaluate imagery rescripting, a technique developed by Smucker&#xD;
      (Smucker, Dancu, Foa, &amp; Niederee, 1995). With the help of various techniques, the approach&#xD;
      aims to edit negative memories and rewrite a &quot;happy end&quot;. Positive mental imagery strategies&#xD;
      seek to hold negative mental images in check and impart the patient with a feeling of&#xD;
      self-efficacy. A new meta-analysis shows that imagery rescripting yields large effects on&#xD;
      anxiety and depressive symptoms across a range of disorders (Morina, Lancee, &amp; Arntz, 2017).&#xD;
&#xD;
      To the best of our knowledge, imagery rescripting has never been tested as a self-help&#xD;
      intervention. A large sample of patients with primary or secondary depression (N = 120) will&#xD;
      be recruited and randomly allocated to either the intervention group or a wait-list control&#xD;
      group. The intervention group consists of two subgroups that will receive either a full or&#xD;
      brief version of a manual teaching them imagery rescripting. Participants will be assessed at&#xD;
      baseline and six weeks later. At post-assessment, the (full-length) manual will be made&#xD;
      available to all participants. A follow-up assessment will be completed six months later. The&#xD;
      primary outcome measure is the Beck Depression Inventory II. Secondary outcome measures&#xD;
      include self-reported symptom measures (PHQ-9, GAF-7, Rosenberg Self-Esteem Scale, Global&#xD;
      item from the WHOQOL-BREF). The project may help to answer the question of whether imagery&#xD;
      rescripting is effective when presented using a self-help medium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</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>randomized-controlled trial, wait-list control condition</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>self-report serves as outcomes, patients are not masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Beck Depression Inventory II</measure>
    <time_frame>Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)</time_frame>
    <description>Beck Depression Inventory II (BDI II) (Beck, Steer, &amp; Brown, 1996). The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression. A follow-up assessment after six month serves as secondary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Change from pre- to post-intervention (i.e. 6 week interval)</time_frame>
    <description>The Patient Health Questionnaire (PHQ-9) is a self-administered scale derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) and measures depression according to the nine depression items of the DSM-IV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rosenberg Self-Esteem Scale (RSE)</measure>
    <time_frame>Change from pre- to post-intervention (i.e. 6 week interval)</time_frame>
    <description>The Rosenberg Self-Esteem Scale (RSE) assesses self-esteem with 10 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorders 7 (GAD-7)</measure>
    <time_frame>Change from pre- to post-intervention (i.e. 6 week interval)</time_frame>
    <description>The Generalized Anxiety Disorders 7 (GAD-7) is a screening instrument for common anxiety symptoms consisting of seven items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global item of the WHO Quality of Life scale (WHOQOL-BREF)</measure>
    <time_frame>Change from pre- to post-intervention (i.e. 6 week interval)</time_frame>
    <description>The global item of the WHO Quality of Life scale (WHOQOL-BREF) assesses quality of Life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>imagery rescripting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>imagery rescripting</intervention_name>
    <description>The long version of the manual contained 4,959 words, the brief version had 3,369 words. Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego. The participant should bring the negative event to a &quot;happy end. This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly). Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene. This technique was then applied to future events. For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest. Using their mind's eye, these images may be transformed into something of beauty or pride.</description>
    <arm_group_label>imagery rescripting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Electronic informed consent&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  Adequate command of the German language&#xD;
&#xD;
          -  Diagnosis of depression (primary or secondary)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute suicidality&#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>Steffen Moritz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKE Hamburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Hamburg Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Moritz S, Ahlf-Schumacher J, Hottenrott B, Peter U, Franck S, Schnell T, Peter H, Schneider BC, Jelinek L. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression. Behav Res Ther. 2018 May;104:74-83. doi: 10.1016/j.brat.2018.02.007. Epub 2018 Feb 26.</citation>
    <PMID>29597112</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <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/NCT03299127
org study id: IR-Phoenix
nct id: NCT03299127
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Depression is among the world's leading causes of disability. To fill the existing treatment
      gap, psychological online interventions (POIs) and Internet-based treatment, including
      bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily
      accessible and deemed an initial alternative approach. The present trial aims to evaluate
      imagery rescripting. With the help of various techniques, the approach aims to edit negative
      memories and rewrite a "happy end". To the best of our knowledge, imagery rescripting has
      never been tested as a self-help intervention. A large sample of patients with primary or
      secondary depression (N = 120) will be recruited and randomly allocated to either the
      intervention group or a wait-list control group. The intervention group consists of two
      subgroups that will receive either a full or brief version of a manual teaching them imagery
      rescripting. Participants will be assessed at baseline and six weeks later. A follow-up
      assessment will be completed six months later. The primary outcome measure is the Beck
      Depression Inventory II.
Depression is among the world's leading causes of disability. Effective pharmacological and
      psychotherapeutic treatments exist. However, only a subgroup of individuals with depressive
      symptoms receive proper treatment (Kohn, Saxena, Levav, & Saraceno, 2004). To fill the
      existing treatment gap (Kazdin, 2017), psychological online interventions (POIs) and
      Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly
      recommended as they are easily accessible and deemed an initial alternative approach (i.e.,
      "foot in the door") for persons who have reservations about face-to-face psychotherapy.
      E-mental health and bilbiotherapeutic interventions have yielded promising results, but there
      remains room for improvement as effect sizes are usually in the small to medium range. The
      present trial aims to evaluate imagery rescripting, a technique developed by Smucker
      (Smucker, Dancu, Foa, & Niederee, 1995). With the help of various techniques, the approach
      aims to edit negative memories and rewrite a "happy end". Positive mental imagery strategies
      seek to hold negative mental images in check and impart the patient with a feeling of
      self-efficacy. A new meta-analysis shows that imagery rescripting yields large effects on
      anxiety and depressive symptoms across a range of disorders (Morina, Lancee, & Arntz, 2017).

      To the best of our knowledge, imagery rescripting has never been tested as a self-help
      intervention. A large sample of patients with primary or secondary depression (N = 120) will
      be recruited and randomly allocated to either the intervention group or a wait-list control
      group. The intervention group consists of two subgroups that will receive either a full or
      brief version of a manual teaching them imagery rescripting. Participants will be assessed at
      baseline and six weeks later. At post-assessment, the (full-length) manual will be made
      available to all participants. A follow-up assessment will be completed six months later. The
      primary outcome measure is the Beck Depression Inventory II. Secondary outcome measures
      include self-reported symptom measures (PHQ-9, GAF-7, Rosenberg Self-Esteem Scale, Global
      item from the WHOQOL-BREF). The project may help to answer the question of whether imagery
      rescripting is effective when presented using a self-help medium.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized-controlled trial, wait-list control condition
primary purpose: Treatment
masking: None (Open Label)
masking description: self-report serves as outcomes, patients are not masked
measure: Beck Depression Inventory II
time frame: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)
description: Beck Depression Inventory II (BDI II) (Beck, Steer, & Brown, 1996). The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression. A follow-up assessment after six month serves as secondary outcome.
measure: Patient Health Questionnaire (PHQ-9)
time frame: Change from pre- to post-intervention (i.e. 6 week interval)
description: The Patient Health Questionnaire (PHQ-9) is a self-administered scale derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) and measures depression according to the nine depression items of the DSM-IV.
measure: Rosenberg Self-Esteem Scale (RSE)
time frame: Change from pre- to post-intervention (i.e. 6 week interval)
description: The Rosenberg Self-Esteem Scale (RSE) assesses self-esteem with 10 items.
measure: Generalized Anxiety Disorders 7 (GAD-7)
time frame: Change from pre- to post-intervention (i.e. 6 week interval)
description: The Generalized Anxiety Disorders 7 (GAD-7) is a screening instrument for common anxiety symptoms consisting of seven items.
measure: Global item of the WHO Quality of Life scale (WHOQOL-BREF)
time frame: Change from pre- to post-intervention (i.e. 6 week interval)
description: The global item of the WHO Quality of Life scale (WHOQOL-BREF) assesses quality of Life.
arm group label: imagery rescripting
arm group type: Experimental
description: bibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version)
arm group label: wait-list control
arm group type: No Intervention
description: wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)
intervention type: Behavioral
intervention name: imagery rescripting
description: The long version of the manual contained 4,959 words, the brief version had 3,369 words. Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego. The participant should bring the negative event to a "happy end. This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly). Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene. This technique was then applied to future events. For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest. Using their mind's eye, these images may be transformed into something of beauty or pride.
arm group label: imagery rescripting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steffen Moritz, PhD
role: Principal Investigator
affiliation: UKE Hamburg
facility: 
country: Germany
citation: Moritz S, Ahlf-Schumacher J, Hottenrott B, Peter U, Franck S, Schnell T, Peter H, Schneider BC, Jelinek L. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression. Behav Res Ther. 2018 May;104:74-83. doi: 10.1016/j.brat.2018.02.007. Epub 2018 Feb 26.
PMID: 29597112
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided