<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/NCT01693237</url>
  </required_header>
  <id_info>
    <org_study_id>10-084080</org_study_id>
    <nct_id>NCT01693237</nct_id>
  </id_info>
  <brief_title>Improving Patient Outcome in Group Therapy for Eating Disorders</brief_title>
  <acronym>F-EAT</acronym>
  <official_title>Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marianne Lau, MD, DSci.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ministry of Science, Technology and Innovation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Psychotherapeutic Center Stolpegard</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current trial aims to investigate the impact of continuous feedback on dropout and&#xD;
      outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist&#xD;
      on treatment progress and alliance will 1) increase adherence and 2) increase treatment&#xD;
      outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: In the psychotherapy of eating disorders, a dropout rate between 30% and 50% is&#xD;
      reported internationally. The fact that up to half of the patients drop out of treatment&#xD;
      calls for ways to improve it. Research shows that feedback to patient and therapist increases&#xD;
      outcome and reduces the number of dropouts; however there is only three published works on&#xD;
      the effect of feedback in eating disorders treatment. Therefore, the present trial, at the&#xD;
      eating disorders unit at Stolpegaard Psychotherapy Centre, Gentofte, Denmark, may contribute&#xD;
      to necessary improvements in the field.&#xD;
&#xD;
      Objective: The current trial, which will be conducted from August 2012 to August 2014, aims&#xD;
      to investigate the impact of continuous feedback on adherence and outcome in group&#xD;
      psychotherapy. The hypothesis is that continuous feedback to patient and therapist on&#xD;
      treatment progress and alliance will 1)increase adherence 2) increase treatment outcome.&#xD;
&#xD;
      Method: The trial is set up in a randomized design with 159 patients allocated to a)&#xD;
      treatment with feedback intervention or b) treatment as usual.&#xD;
&#xD;
      Participants: The participants are diagnosed with Bulimia Nervosa, Binge Eating Disorder or&#xD;
      Eating Disorder Not Otherwise Specified.&#xD;
&#xD;
      Interventions: In the experimental group, two sets of feedback measures are added to the&#xD;
      standard treatment: Outcome Rating Scale (ORS) and Group Session Rating Scale (GSRS). The ORS&#xD;
      assesses areas of life functioning known to change as a result of therapeutic intervention.&#xD;
      The GSRS assesses key dimensions of effective therapeutic relationships.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.</time_frame>
    <description>Treatment adherence in the intervention period defined as a rate, i.e., number of attended therapy sessions divided by the number of planned therapy sessions. If a patient ends therapy prematurely, and this is in accordance with the therapists, the number of attended sessions will be set equal to the planned number of sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Disorders Examination Interview</measure>
    <time_frame>At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of 3 years.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-Harm Inventory</measure>
    <time_frame>At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Outcome Rating Scale</measure>
    <time_frame>At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Symptom Check List-90R</measure>
    <time_frame>At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sheehan Disability Scale</measure>
    <time_frame>At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>WHO-Five Well-being Index</measure>
    <time_frame>At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Bulimia Nervosa (BN)</condition>
  <condition>Binge Eating Disorder (BED)</condition>
  <condition>Eating Disorder Not Otherwise Specified (EDNOS)</condition>
  <arm_group>
    <arm_group_label>Group psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 sessions of systemic and narrative group psychotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group psychotherapy with feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group psychotherapy</intervention_name>
    <description>20 sessions of systemic and narrative group therapy</description>
    <arm_group_label>Group psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group psychotherapy with feedback</intervention_name>
    <description>20 sessions of systemic and narrative group therapy</description>
    <arm_group_label>Group psychotherapy with feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or older.&#xD;
&#xD;
          -  BMI of minimum 20.&#xD;
&#xD;
          -  Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS&#xD;
             according to DSM- IV.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute suicidal risk.&#xD;
&#xD;
          -  Psychosis.&#xD;
&#xD;
          -  Severe depression.&#xD;
&#xD;
          -  Abuse of alcohol, medicine and/or narcotics up to 3 months before referral.&#xD;
&#xD;
          -  Use of cannabis once a month is accepted at intake but must stop during treatment.&#xD;
&#xD;
          -  Concomitant psychotherapeutic/ psychiatric treatment outside Stolpegaard Psychotherapy&#xD;
             Centre.&#xD;
&#xD;
          -  Severe or non-regulated physical co-morbidity.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Unable to understand Danish.&#xD;
&#xD;
          -  Previous participation in the current trial.&#xD;
&#xD;
          -  Considered unable to attend treatment sessions as planned.&#xD;
&#xD;
          -  Lack of informed consent.&#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>Marianne E. Lau, D.Sci.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stolpegaard Psychotherapy Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stolpegaard Psychotherapy Centre</name>
      <address>
        <city>Gentofte</city>
        <zip>2820</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>February 25, 2014</last_update_submitted>
  <last_update_submitted_qc>February 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Psychotherapeutic Center Stolpegard</investigator_affiliation>
    <investigator_full_name>Marianne Lau, MD, DSci.</investigator_full_name>
    <investigator_title>Research Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Binge-Eating Disorder</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
  </condition_browse>
  <!-- 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/NCT01693237
org study id: 10-084080
nct id: NCT01693237
lead sponsor: 
collaborator: 
has dmc: Yes
The current trial aims to investigate the impact of continuous feedback on dropout and
      outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist
      on treatment progress and alliance will 1) increase adherence and 2) increase treatment
      outcome.
Background: In the psychotherapy of eating disorders, a dropout rate between 30% and 50% is
      reported internationally. The fact that up to half of the patients drop out of treatment
      calls for ways to improve it. Research shows that feedback to patient and therapist increases
      outcome and reduces the number of dropouts; however there is only three published works on
      the effect of feedback in eating disorders treatment. Therefore, the present trial, at the
      eating disorders unit at Stolpegaard Psychotherapy Centre, Gentofte, Denmark, may contribute
      to necessary improvements in the field.

      Objective: The current trial, which will be conducted from August 2012 to August 2014, aims
      to investigate the impact of continuous feedback on adherence and outcome in group
      psychotherapy. The hypothesis is that continuous feedback to patient and therapist on
      treatment progress and alliance will 1)increase adherence 2) increase treatment outcome.

      Method: The trial is set up in a randomized design with 159 patients allocated to a)
      treatment with feedback intervention or b) treatment as usual.

      Participants: The participants are diagnosed with Bulimia Nervosa, Binge Eating Disorder or
      Eating Disorder Not Otherwise Specified.

      Interventions: In the experimental group, two sets of feedback measures are added to the
      standard treatment: Outcome Rating Scale (ORS) and Group Session Rating Scale (GSRS). The ORS
      assesses areas of life functioning known to change as a result of therapeutic intervention.
      The GSRS assesses key dimensions of effective therapeutic relationships.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Adherence
time frame: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
description: Treatment adherence in the intervention period defined as a rate, i.e., number of attended therapy sessions divided by the number of planned therapy sessions. If a patient ends therapy prematurely, and this is in accordance with the therapists, the number of attended sessions will be set equal to the planned number of sessions.
measure: Eating Disorders Examination Interview
time frame: At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of 3 years.
measure: Self-Harm Inventory
time frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.
measure: Outcome Rating Scale
time frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
measure: Symptom Check List-90R
time frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
measure: Sheehan Disability Scale
time frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
measure: WHO-Five Well-being Index
time frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
arm group label: Group psychotherapy
arm group type: Active Comparator
description: 20 sessions of systemic and narrative group psychotherapy
arm group label: Group psychotherapy with feedback
arm group type: Experimental
description: 20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.
intervention type: Other
intervention name: Group psychotherapy
description: 20 sessions of systemic and narrative group therapy
arm group label: Group psychotherapy
intervention type: Other
intervention name: Group psychotherapy with feedback
description: 20 sessions of systemic and narrative group therapy
arm group label: Group psychotherapy with feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marianne E. Lau, D.Sci.
role: Principal Investigator
affiliation: Stolpegaard Psychotherapy Centre
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Psychotherapeutic Center Stolpegard
investigator full name: Marianne Lau, MD, DSci.
investigator title: Research Manager
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Binge-Eating Disorder
mesh term: Bulimia Nervosa