xml: <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/NCT05976945</url>
    </required_header>
    <id_info>
      <org_study_id>2021-CP-14288</org_study_id>
      <nct_id>NCT05976945</nct_id>
    </id_info>
    <brief_title>Imagery Rescripting as Treatment for Depression</brief_title>
    <official_title>Imagery Rescripting as a Stand-alone Treatment for Depression: a Pilot Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Amsterdam</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Academic Center for Trauma and Personality</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Amsterdam</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 goal of this multiple baseline case series study is to test Imagery Rescripting in&#xD;
        depression. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  does Imagery Rescripting lead to a reduction of depression and of believability of&#xD;
             negative beliefs held by the participants?&#xD;
  &#xD;
          -  does Imagery Rescripting also leads to reductions in worrying and brooding?&#xD;
  &#xD;
          -  Participants will wait for 6-10 weeks (to assess time effects without treatment),&#xD;
             followed by 5 weekly preparation sessions, 8-12 weekly Imagery Rescripting sessions, and&#xD;
             5 weeks post-treatment.&#xD;
  &#xD;
          -  Participants will rate the believability of 3-5 core dysfunctional beliefs related to&#xD;
             their depression as well as 2 items assessing depression severity on a weekly basis. In&#xD;
             addition, they will fill out more extensive questionnaires on depression, worry and&#xD;
             brooding before each phase, as well as at 5 weeks post-treatment, and 6 and 12 months&#xD;
             follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In a multiple baseline case series study the effectiveness of Imagery Rescripting (ImRs) as a&#xD;
        treatment for depression will be tested. 10 patients with a major depressive disorder (MDD)&#xD;
        or a persistent depressive disorder (PDD) will be randomized to different waitlist lengths&#xD;
        (6-10 weeks), after which they will enter a 5-session preparation phase (5 weeks), followed&#xD;
        by 12 weekly sessions of ImRs. After this treatment follow-up assessments take place at 5&#xD;
        weeks, 6 and 12 months. Primary outcomes are (1) depression severity weekly assessed with the&#xD;
        Patient Health Questionnaire (PHQ-2) and (2) idiosyncratic core beliefs assessed with visual&#xD;
        analogue scales. The hypothesis is that primary outcomes reduce more during treatment than&#xD;
        during wait or preparation and remain stable or further improve post-treatment. Similarly,&#xD;
        for secondary outcomes (depression severity assessed with the Beck Depression Inventory II&#xD;
        (BDI-II); brooding (dysfunctional type of rumination) assessed with the Ruminative Response&#xD;
        Scale (RRS) Brooding subscale; and worrying assessed with the Penn State Worry Questionnaire&#xD;
        (PSWQ)) we expect the largest improvement to take place from pre- to post treatment, with&#xD;
        little change taking place during baseline and preparation, and during/after post-treatment.&#xD;
  &#xD;
        Results will be analyzed by multilevel analysis, pooling the effects of the individual cases.&#xD;
        Lastly, participants will be interviewed 5 weeks post treatment about their experiences with&#xD;
        treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Multiple baseline case series design: by randomizing participants to different lengths of waitlist (baseline) and comparing means and slopes of weekly reported depression severity and core beliefs, the effectiveness of the treatment is tested.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Depression severity</measure>
      <time_frame>28-32 weeks plus 6 and 12 months follow-ups</time_frame>
      <description>Depression severity assessed with the first 2 items of the Patient Health Questionnaire-9. The minimum score is 0, the maximum score is 6. A higher score means worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Core beliefs strength</measure>
      <time_frame>28-32 weeks plus 6 and 12 months follow-ups</time_frame>
      <description>Idiosyncratic core beliefs related to the depression are formulated together with the participant and weekly rated on Visual Analogue Scales.The mean of the scores is taken, range 0-100. A higher score means a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Beck Depression Inventory-II</measure>
      <time_frame>before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups</time_frame>
      <description>The Beck Depression Inventory-II assesses severity of depression. The minimum score is 0, the maximum score is 63. Higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brooding intensity</measure>
      <time_frame>before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups</time_frame>
      <description>The Brooding subscale of the Ruminative Response Scale assesses intensity of problematic brooding. The minimum score is 5, the maximum is 20. Higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Worry intensity</measure>
      <time_frame>before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups</time_frame>
      <description>The Penn State Worry Questionnaire assesses intensity of problematic worrying. The minimum score is 16, the maximum 80. Higher scores mean worse outcomes.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>patients' experiences</measure>
      <time_frame>5 weeks after end of treatment</time_frame>
      <description>with a semi-structured interview, participants will be interviewed 5 weeks after treatment. A qualitative analysis will be used.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Major Depressive Disorder</condition>
    <condition>Persistent Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Baseline-Preparation-Imagery Rescripting-Post Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each participant follows this sequence: (1) 6-10 weeks waitlist during which no treatment is offered; (2) 5 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 8 to 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The stand-alone ImRs treatment will be based upon the protocol described by Arntz &amp; Weertman (1999). (This protocol can be modified to tailor the needs of this study more specifically. Possible adaptations shall be based upon the manual developed by Brewin and colleagues (2009) for their study of applying ImRs to depression.); (4) After end of active treatment (ImRs) 5 weeks follow during which only weekly assessments are done.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Imagery Rescripting</intervention_name>
      <description>In Imagery Rescripting patients imagine a different sequence of events matching their needs better than what actually happened in traumatic and other adverse (childhood) experiences.</description>
      <arm_group_label>Baseline-Preparation-Imagery Rescripting-Post Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary diagnosis of MDD as assessed with the Structured Clinical Interview for&#xD;
               Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5)&#xD;
  &#xD;
            -  Total score of 20* or above on the BDI-II (cut-off score for moderate depression)&#xD;
               (Beck et al., 1996). (*Based on previous research by Brewin et al. (2009) &amp; Yuen-tin&#xD;
               (2017) demonstrating averages of BDI-II: 34-35, in their population.)&#xD;
  &#xD;
            -  Age 18-65&#xD;
  &#xD;
            -  Dutch or English as a first language (or estimated as sufficient to receive treatment&#xD;
               in either of these languages without interpreter)&#xD;
  &#xD;
            -  Willingness to participate in the study (signed informed consent)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  DSM-5 Bipolar disorder, type 1 (current or past); if there has been no manic episode&#xD;
               the last year patients will be included&#xD;
  &#xD;
            -  Psychotic disorders (though psychotic features alongside depression will be allowed)&#xD;
  &#xD;
            -  Organic brain disease&#xD;
  &#xD;
            -  Intelligence Quotient (IQ) &lt; 80&#xD;
  &#xD;
            -  High risk of self-harm or suicide&#xD;
  &#xD;
            -  Current substance abuse severe level&#xD;
  &#xD;
            -  Start of new medication within 2 months before beginning the study (medication used&#xD;
               for longer periods can be continued; patients are requested to keep medication stable&#xD;
               during the course of the study)&#xD;
  &#xD;
            -  Having received ImRs (either as a stand-alone or embedded in a greater treatment such&#xD;
               as cognitive behavior therapy (CBT) or schema therapy) within the last year&#xD;
  &#xD;
            -  No other evidence-based treatment of MDD is allowed during the study.&#xD;
  &#xD;
            -  Not able to plan enough time for weekly therapy sessions (45-60 minutes); weekly&#xD;
               measurements (estimate of 5 minutes) and other measurements (estimate of 20 minutes);&#xD;
               and the qualitative post-treatment interview (estimate of 60 minutes) during the study&#xD;
               period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arnoud Arntz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Amsterdam</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Arnoud Arntz, PhD</last_name>
      <phone>+31 20 525 6728</phone>
      <email>a.r.arntz@uva.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Caitlin Tauber, MSc</last_name>
      <email>caitlin.tauber@actp.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Academic Center for Trauma and Personality ACTP</name>
        <address>
          <city>Amsterdam</city>
          <zip>1062 XD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Arnoud R. Arntz, PhD</last_name>
        <phone>+31205256810</phone>
        <email>a.r.arntz@uva.nl</email>
      </contact>
      <contact_backup>
        <last_name>Caitlin Tauber, MSc</last_name>
        <email>caitlin.tauber@actp.nl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Amsterdam</investigator_affiliation>
      <investigator_full_name>Arnoud Arntz</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </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>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 27, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT05976945/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976945
  org study id: 2021-CP-14288
  nct id: NCT05976945
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multiple baseline case series study is to test Imagery Rescripting in
        depression. The main question[s] it aims to answer are:
  
          -  does Imagery Rescripting lead to a reduction of depression and of believability of
             negative beliefs held by the participants?
  
          -  does Imagery Rescripting also leads to reductions in worrying and brooding?
  
          -  Participants will wait for 6-10 weeks (to assess time effects without treatment),
             followed by 5 weekly preparation sessions, 8-12 weekly Imagery Rescripting sessions, and
             5 weeks post-treatment.
  
          -  Participants will rate the believability of 3-5 core dysfunctional beliefs related to
             their depression as well as 2 items assessing depression severity on a weekly basis. In
             addition, they will fill out more extensive questionnaires on depression, worry and
             brooding before each phase, as well as at 5 weeks post-treatment, and 6 and 12 months
             follow-up.
  In a multiple baseline case series study the effectiveness of Imagery Rescripting (ImRs) as a
        treatment for depression will be tested. 10 patients with a major depressive disorder (MDD)
        or a persistent depressive disorder (PDD) will be randomized to different waitlist lengths
        (6-10 weeks), after which they will enter a 5-session preparation phase (5 weeks), followed
        by 12 weekly sessions of ImRs. After this treatment follow-up assessments take place at 5
        weeks, 6 and 12 months. Primary outcomes are (1) depression severity weekly assessed with the
        Patient Health Questionnaire (PHQ-2) and (2) idiosyncratic core beliefs assessed with visual
        analogue scales. The hypothesis is that primary outcomes reduce more during treatment than
        during wait or preparation and remain stable or further improve post-treatment. Similarly,
        for secondary outcomes (depression severity assessed with the Beck Depression Inventory II
        (BDI-II); brooding (dysfunctional type of rumination) assessed with the Ruminative Response
        Scale (RRS) Brooding subscale; and worrying assessed with the Penn State Worry Questionnaire
        (PSWQ)) we expect the largest improvement to take place from pre- to post treatment, with
        little change taking place during baseline and preparation, and during/after post-treatment.
  
        Results will be analyzed by multilevel analysis, pooling the effects of the individual cases.
        Lastly, participants will be interviewed 5 weeks post treatment about their experiences with
        treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Multiple baseline case series design: by randomizing participants to different lengths of waitlist (baseline) and comparing means and slopes of weekly reported depression severity and core beliefs, the effectiveness of the treatment is tested.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.
  measure: Depression severity
  time frame: 28-32 weeks plus 6 and 12 months follow-ups
  description: Depression severity assessed with the first 2 items of the Patient Health Questionnaire-9. The minimum score is 0, the maximum score is 6. A higher score means worse outcome.
  measure: Core beliefs strength
  time frame: 28-32 weeks plus 6 and 12 months follow-ups
  description: Idiosyncratic core beliefs related to the depression are formulated together with the participant and weekly rated on Visual Analogue Scales.The mean of the scores is taken, range 0-100. A higher score means a worse outcome.
  measure: Beck Depression Inventory-II
  time frame: before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups
  description: The Beck Depression Inventory-II assesses severity of depression. The minimum score is 0, the maximum score is 63. Higher scores mean worse outcomes.
  measure: Brooding intensity
  time frame: before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups
  description: The Brooding subscale of the Ruminative Response Scale assesses intensity of problematic brooding. The minimum score is 5, the maximum is 20. Higher scores mean worse outcomes.
  measure: Worry intensity
  time frame: before baseline, before preparatory sessions, before ImRs treatment, 5 weeks after ImRs treatment, 6 and 12 months follow-ups
  description: The Penn State Worry Questionnaire assesses intensity of problematic worrying. The minimum score is 16, the maximum 80. Higher scores mean worse outcomes.
  measure: patients' experiences
  time frame: 5 weeks after end of treatment
  description: with a semi-structured interview, participants will be interviewed 5 weeks after treatment. A qualitative analysis will be used.
  arm group label: Baseline-Preparation-Imagery Rescripting-Post Treatment
  arm group type: Experimental
  description: Each participant follows this sequence: (1) 6-10 weeks waitlist during which no treatment is offered; (2) 5 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 8 to 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The stand-alone ImRs treatment will be based upon the protocol described by Arntz & Weertman (1999). (This protocol can be modified to tailor the needs of this study more specifically. Possible adaptations shall be based upon the manual developed by Brewin and colleagues (2009) for their study of applying ImRs to depression.); (4) After end of active treatment (ImRs) 5 weeks follow during which only weekly assessments are done.
  intervention type: Behavioral
  intervention name: Imagery Rescripting
  description: In Imagery Rescripting patients imagine a different sequence of events matching their needs better than what actually happened in traumatic and other adverse (childhood) experiences.
  arm group label: Baseline-Preparation-Imagery Rescripting-Post Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Arnoud Arntz, PhD
  role: Principal Investigator
  affiliation: University of Amsterdam
  last name: Arnoud Arntz, PhD
  phone: +31 20 525 6728
  email: a.r.arntz@uva.nl
  last name: Caitlin Tauber, MSc
  email: caitlin.tauber@actp.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: University of Amsterdam
  investigator full name: Arnoud Arntz
  investigator title: Professor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: No
  ipd description: because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.
  provided document: 