<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/NCT03022071</url>
  </required_header>
  <id_info>
    <org_study_id>What works for whom and how?</org_study_id>
    <nct_id>NCT03022071</nct_id>
  </id_info>
  <brief_title>Mechanisms of Change in Psychotherapy</brief_title>
  <acronym>MOP</acronym>
  <official_title>What Works for Whom and How? Mechanisms of Change in Psychotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</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>
      Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated&#xD;
      with significant disability, mortality and economic burden. MDD is ranked fourth in terms of&#xD;
      disease burden as defined by the World Health Organization (2001). Cognitive Behavioral&#xD;
      Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for&#xD;
      patients with depression. However, many patients do not respond sufficiently to treatment and&#xD;
      relapse rates are high. To be able to offer individualized treatment, a clinically important&#xD;
      question is therefore whether some patients profit more from one of the two therapies. At&#xD;
      present little is known on which patient characteristics (moderators) may be associated with&#xD;
      differential outcomes of CBT and PDT and through what kind of therapeutic processes and&#xD;
      mechanisms (mediators) improvements occur in each therapy mode. There are actually only&#xD;
      theoretical assumptions sparsely supported by research findings on what moderates and&#xD;
      mediates the treatment effects of CBT and PDT.&#xD;
&#xD;
      Aims: The overall aim of this project is to examine putative moderators and mediators in CBT&#xD;
      and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for&#xD;
      patients with MDD.&#xD;
&#xD;
      Methods and study design: The study is a randomized clinical trial. One hundred patients will&#xD;
      be randomized to one of two treatment conditions. The patients will be treated over 28 weeks&#xD;
      with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the&#xD;
      rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will&#xD;
      be evaluated at baseline, during therapy, at the end of therapy, and at follow-up&#xD;
      investigations 1 and 3 years after treatment termination. The outcome measures comprise a&#xD;
      large range of clinical and process variables, including assessment tools measuring specific&#xD;
      preselected putative moderators and mediators.&#xD;
&#xD;
      Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of&#xD;
      treatment should be offered the individual patient. Moreover, it will shed light on what kind&#xD;
      of mechanisms in psychotherapy that is followed by symptom improvement and increased&#xD;
      psychosocial functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>In this study we want to examine moderators and mediators in two equally effective, well known psychotherapeutic treatments (Psychodynamic and cognitive behavior therapy)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessments will be provided by raters blinded to the randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up</time_frame>
    <description>Assessment of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Index</measure>
    <time_frame>Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up</time_frame>
    <description>Assessment of depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychodynamic Functioning Scale</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (one and three years)</time_frame>
    <description>Assesment of dynamic functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Cognitive Insight Score</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Assessment of cognitive insight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assesment of Functioning</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (one and three years)</time_frame>
    <description>Assessment of global symptoms and functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inventory of Interpersonal Problems</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (one and three years)</time_frame>
    <description>Measure of interpersonal problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflective functioning - depression</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (one and three years)</time_frame>
    <description>Assessment of reflective functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysfunctional Attitude Scale</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Measure of dysfunctional attitude</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metacognitive questionnaire</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Assessments of metacognition</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Work and Social Adjustment Scale</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Assessment of functioning</description>
  </other_outcome>
  <other_outcome>
    <measure>The Short Form Health Survey</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Measure of general Health issues</description>
  </other_outcome>
  <other_outcome>
    <measure>Childhood Trauma Questionnaire</measure>
    <time_frame>Baseline (inclusion). Moderator of treatment</time_frame>
    <description>Measure of childhood trauma</description>
  </other_outcome>
  <other_outcome>
    <measure>Severity of Indices of personality Problems</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Assessments of personality dimensions</description>
  </other_outcome>
  <other_outcome>
    <measure>Toronto Alexithymia Scale</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Measures of alexithymia</description>
  </other_outcome>
  <other_outcome>
    <measure>Rumination respons scale</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Measures of ruminations</description>
  </other_outcome>
  <other_outcome>
    <measure>Structural Analysis of Social Behavior</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Measure social behavior</description>
  </other_outcome>
  <other_outcome>
    <measure>Experience in Close Relationship Inventory</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Functioning in Close relations</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Health questionnaire</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)</time_frame>
    <description>Measure anxiety</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypomani Checlist</measure>
    <time_frame>Change in scores during therapy and the follow-up periode (one and three years)</time_frame>
    <description>Measures hypomanic symptoms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychodynamic psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive behavior therapy</intervention_name>
    <description>In this study we want to compare CBT and PDT and examine whether some patients will benefit from CBT and other from PDT. More specifically we want to examine moderators and mediators for improvement in depressive symptoms in the two interventions arms.</description>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_label>Psychodynamic psychotherapy</arm_group_label>
    <other_name>Psychodynamic psychotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18-65 years, with depressive disorder according to the&#xD;
             Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV;&#xD;
             American Psychiatric Association, 2000) unipolar MDD diagnosis will be included.MINI&#xD;
             plus (Sheehan et al., 1998 will be used as assessment tool. Comorbidity is expected to&#xD;
             be frequent. Written consent will be obtained from all patients.&#xD;
&#xD;
          -  The participants need to have the ability to speak and understand a Scandinavian&#xD;
             language, and willingness and ability to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past neurological illness, traumatic brain injury, current alcohol and/or&#xD;
             substance dependency disorders, psychotic disorders, developmental disorders, and&#xD;
             mental retardation.&#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>Jan I Røssberg, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan I Røssberg, PhD</last_name>
    <phone>+47 47876866</phone>
    <email>j.i.rossberg@medisin.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Randi Ulberg, PhD</last_name>
    <phone>+47 95883479</phone>
    <email>randi.ulberg@medisin.uio.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0407</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan I Røssberg, PhD</last_name>
      <phone>+47 47876866</phone>
      <email>j.i.rossberg@medisin.uio.no</email>
    </contact>
    <contact_backup>
      <last_name>Randi Ulberg, PhD</last_name>
      <phone>+47 95883479</phone>
      <email>randi.ulberg@medisin.uio.no</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Jan Ivar Røssberg, MD</investigator_full_name>
    <investigator_title>Professor MD PhD</investigator_title>
  </responsible_party>
  <keyword>Cognitive behavior therapy</keyword>
  <keyword>Psychodynamic therapy</keyword>
  <keyword>Mediators</keyword>
  <keyword>Moderators</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
  </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/NCT03022071
org study id: What works for whom and how?
nct id: NCT03022071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated
      with significant disability, mortality and economic burden. MDD is ranked fourth in terms of
      disease burden as defined by the World Health Organization (2001). Cognitive Behavioral
      Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for
      patients with depression. However, many patients do not respond sufficiently to treatment and
      relapse rates are high. To be able to offer individualized treatment, a clinically important
      question is therefore whether some patients profit more from one of the two therapies. At
      present little is known on which patient characteristics (moderators) may be associated with
      differential outcomes of CBT and PDT and through what kind of therapeutic processes and
      mechanisms (mediators) improvements occur in each therapy mode. There are actually only
      theoretical assumptions sparsely supported by research findings on what moderates and
      mediates the treatment effects of CBT and PDT.

      Aims: The overall aim of this project is to examine putative moderators and mediators in CBT
      and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for
      patients with MDD.

      Methods and study design: The study is a randomized clinical trial. One hundred patients will
      be randomized to one of two treatment conditions. The patients will be treated over 28 weeks
      with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the
      rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will
      be evaluated at baseline, during therapy, at the end of therapy, and at follow-up
      investigations 1 and 3 years after treatment termination. The outcome measures comprise a
      large range of clinical and process variables, including assessment tools measuring specific
      preselected putative moderators and mediators.

      Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of
      treatment should be offered the individual patient. Moreover, it will shed light on what kind
      of mechanisms in psychotherapy that is followed by symptom improvement and increased
      psychosocial functioning.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study we want to examine moderators and mediators in two equally effective, well known psychotherapeutic treatments (Psychodynamic and cognitive behavior therapy)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessments will be provided by raters blinded to the randomization
measure: Hamilton Depression Rating Scale
time frame: Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up
description: Assessment of depression
measure: Beck Depression Index
time frame: Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up
description: Assessment of depression
measure: Psychodynamic Functioning Scale
time frame: Change in scores during therapy and the follow-up periode (one and three years)
description: Assesment of dynamic functioning
measure: Beck Cognitive Insight Score
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Assessment of cognitive insight
measure: Global Assesment of Functioning
time frame: Change in scores during therapy and the follow-up periode (one and three years)
description: Assessment of global symptoms and functioning
measure: Inventory of Interpersonal Problems
time frame: Change in scores during therapy and the follow-up periode (one and three years)
description: Measure of interpersonal problems
measure: Reflective functioning - depression
time frame: Change in scores during therapy and the follow-up periode (one and three years)
description: Assessment of reflective functioning
measure: Dysfunctional Attitude Scale
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Measure of dysfunctional attitude
measure: Metacognitive questionnaire
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Assessments of metacognition
measure: Work and Social Adjustment Scale
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Assessment of functioning
measure: The Short Form Health Survey
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Measure of general Health issues
measure: Childhood Trauma Questionnaire
time frame: Baseline (inclusion). Moderator of treatment
description: Measure of childhood trauma
measure: Severity of Indices of personality Problems
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Assessments of personality dimensions
measure: Toronto Alexithymia Scale
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Measures of alexithymia
measure: Rumination respons scale
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Measures of ruminations
measure: Structural Analysis of Social Behavior
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Measure social behavior
measure: Experience in Close Relationship Inventory
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Functioning in Close relations
measure: Patient Health questionnaire
time frame: Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
description: Measure anxiety
measure: Hypomani Checlist
time frame: Change in scores during therapy and the follow-up periode (one and three years)
description: Measures hypomanic symptoms
arm group label: Cognitive behavior therapy
arm group type: Experimental
description: The included patients will receive cognitive therapy for depression for 16 weeks and monthly booster sessions up to 28 weeks.
arm group label: Psychodynamic psychotherapy
arm group type: Active Comparator
description: The included patients will receive time-limited psychodynamic psychotherapy for 28 weeks.
intervention type: Other
intervention name: Cognitive behavior therapy
description: In this study we want to compare CBT and PDT and examine whether some patients will benefit from CBT and other from PDT. More specifically we want to examine moderators and mediators for improvement in depressive symptoms in the two interventions arms.
arm group label: Cognitive behavior therapy
arm group label: Psychodynamic psychotherapy
other name: Psychodynamic psychotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jan I Røssberg, phD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Jan I Røssberg, PhD
phone: +47 47876866
email: j.i.rossberg@medisin.uio.no
last name: Randi Ulberg, PhD
phone: +47 95883479
email: randi.ulberg@medisin.uio.no
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Jan Ivar Røssberg, MD
investigator title: Professor MD PhD
mesh term: Depression
sharing ipd: Undecided
ipd description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.