<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/NCT04421651</url>
  </required_header>
  <id_info>
    <org_study_id>UJyvaskyla DMT trial</org_study_id>
    <nct_id>NCT04421651</nct_id>
  </id_info>
  <brief_title>Dance Movement Therapy in the Treatment of Depressed Patients: A Randomised Controlled Trial</brief_title>
  <official_title>Dance Movement Therapy in the Treatment of Depressed Patients: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jyvaskyla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Social Insurance Institution of Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Finnish Dance Therapy Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Jyvaskyla</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>
      This multi-centre research investigates the effects of dance movement therapy (DMT) on&#xD;
      participants diagnosed with depression. In total, 109 persons participated in the study in&#xD;
      various locations in Finland. All participants received treatment as usual (TAU). They were&#xD;
      randomised into DMT + TAU (n = 52) or TAU-only (n = 57). The participants in the DMT + TAU&#xD;
      group were offered 20 DMT sessions twice a week for 10 weeks in addition to standard care.&#xD;
      The measurement points included pre-treatment measurement at the baseline and post-treatment&#xD;
      measurement at the end of the intervention, which was 10 weeks after the pre-treatment&#xD;
      measurement. The follow-up measurement was 3 months after the post-treatment measurement. The&#xD;
      effects of the intervention were assessed with a clinical measure of depression (BDI-I) and&#xD;
      with indicators of physical and psychological distress (CORE-OM and SCL-90). The participants&#xD;
      in the treatment group (DMT+TAU) were compared to the participants in the control group who&#xD;
      received TAU-only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research investigates the outcomes of dance movement therapy (DMT) groups in the&#xD;
      treatment of adults with depression. In total, 157 participants were involved. Of them, 109&#xD;
      were randomized into DMT group (n = 52) or control group (n = 57). The rest of the&#xD;
      participants participated in non-randomized DMT groups. All participants met the criteria for&#xD;
      the eligibility for rehabilitation psychotherapy, had depression diagnosed by a doctor, and&#xD;
      the severity of depression threatened the ability to work/ study. All participants received&#xD;
      treatment as usual during the research. DMT-intervention was facilitated by a dance movement&#xD;
      therapist and included 20 x 75 mins sessions within 10 weeks. Depressive symptoms (BDI),&#xD;
      physical and psychological distress (CORE-OM, SCL-90), ability to work/study, and body image&#xD;
      were assessed at three measurement points: pre-measurement at the baseline, post-measurement&#xD;
      10 weeks after the pre-treatment measurement, and a follow-up measurement three months after&#xD;
      the post-treatment measurement.&#xD;
&#xD;
      This research includes a larger number of participants (N = 109) than have been involved in&#xD;
      previous studies utilising randomised controlled trials in research designs. The research&#xD;
      generates further information about the effectiveness of dance movement therapy groups in the&#xD;
      rehabilitation of depression as it was conducted in five cities across Finland. This type of&#xD;
      multi-centre research can provide a realistic picture of the typical practice of a range of&#xD;
      dance movement therapists working with participants in various geographic locations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline depressive symptoms (Beck Depression Inventory; BDI) at 10-week post-treatment measurement</measure>
    <time_frame>10 weeks</time_frame>
    <description>BDI measures depressive symptoms with 21 items. Each item is scored 0-3 and sum scores are calculated on the basis of participants' responses. The total sum score can range from 0 to 63.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from post-treatment depressive symptoms (Beck Depression Inventory; BDI) at three-month follow-up measurement</measure>
    <time_frame>3 months</time_frame>
    <description>The change in depressive symptoms between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at 10-week post-treatment measurement</measure>
    <time_frame>10 weeks</time_frame>
    <description>The CORE-OM comprises 43 items and four dimensions of well-being, problems, life functioning, and risk for aggressive/suicidal behaviour. Each item is scored from 0 to 4. CORE-OM items are summed and then divided by the number of answered items, which is then multiplied by ten; that is, the total scores ranges from 0 to 40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from post-treatment psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at three-month follow-up measurement</measure>
    <time_frame>3 months</time_frame>
    <description>The change in psychological distress (CORE-OM) between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at 10-week post-treatment measurement</measure>
    <time_frame>10 weeks</time_frame>
    <description>SCL-90 uses 90 items to measure nine primary symptomatic dimensions, including somatisation, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The level of distress is scored on a scale from 0 to 4. An average score of the 90 items is calculated, which represents the severity of the participant's symptoms, that is, the Global Severity Index (GSI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from post-treatment physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at three-month follow-up measurement</measure>
    <time_frame>3 months</time_frame>
    <description>The change in physiological and psychological symptoms (SCL-90) between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in the treatment group were offered 20 Dance movement therapy sessions in addition to standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group continued treatment as usual in the health services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dance Movement Therapy group</intervention_name>
    <description>DMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participant needed to have a diagnoses of depression by a psychiatrist or general&#xD;
             practitioner (ICD -diagnostic system). The researchers checked that the participants&#xD;
             were working age (18-65 years of age) and fulfilled the criteria for rehabilitative&#xD;
             psychotherapy in Finland: at least three months of relevant treatment since depression&#xD;
             was diagnosed; the participants' ability to work or study is impaired by depression; a&#xD;
             psychiatrist has determined that rehabilitative psychotherapy is necessary to improve&#xD;
             or support the participant's ability to work or study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active suicidal ideation; psychotic symptoms; substance misuse that is on a critical&#xD;
             level. Also, interviewees who had pain-related problems that restricted daily life or&#xD;
             were pregnant were not admitted to the study.&#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>Raimo Lappalainen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Jyvaskyla</affiliation>
  </overall_official>
  <link>
    <url>https://www.jyu.fi/edupsy/fi/laitokset/psykologia/tutkimus/tutkimusalueet/kliininen-psykologia-ja-psykoterapia/ryhmamuotoinen-tanssi-liiketerapia-kuntoutusmuotona-masennuspotilaille</url>
    <description>Research project website</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dance Movement Therapy</keyword>
  <keyword>Adults</keyword>
  <keyword>Depression</keyword>
  <keyword>Beck Depression Inventory</keyword>
  <keyword>Clinical Outcomes in Routine Evaluation - Outcome Measure</keyword>
  <keyword>The Symptoms Check List-90</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>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/NCT04421651
org study id: UJyvaskyla DMT trial
nct id: NCT04421651
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multi-centre research investigates the effects of dance movement therapy (DMT) on
      participants diagnosed with depression. In total, 109 persons participated in the study in
      various locations in Finland. All participants received treatment as usual (TAU). They were
      randomised into DMT + TAU (n = 52) or TAU-only (n = 57). The participants in the DMT + TAU
      group were offered 20 DMT sessions twice a week for 10 weeks in addition to standard care.
      The measurement points included pre-treatment measurement at the baseline and post-treatment
      measurement at the end of the intervention, which was 10 weeks after the pre-treatment
      measurement. The follow-up measurement was 3 months after the post-treatment measurement. The
      effects of the intervention were assessed with a clinical measure of depression (BDI-I) and
      with indicators of physical and psychological distress (CORE-OM and SCL-90). The participants
      in the treatment group (DMT+TAU) were compared to the participants in the control group who
      received TAU-only.
This research investigates the outcomes of dance movement therapy (DMT) groups in the
      treatment of adults with depression. In total, 157 participants were involved. Of them, 109
      were randomized into DMT group (n = 52) or control group (n = 57). The rest of the
      participants participated in non-randomized DMT groups. All participants met the criteria for
      the eligibility for rehabilitation psychotherapy, had depression diagnosed by a doctor, and
      the severity of depression threatened the ability to work/ study. All participants received
      treatment as usual during the research. DMT-intervention was facilitated by a dance movement
      therapist and included 20 x 75 mins sessions within 10 weeks. Depressive symptoms (BDI),
      physical and psychological distress (CORE-OM, SCL-90), ability to work/study, and body image
      were assessed at three measurement points: pre-measurement at the baseline, post-measurement
      10 weeks after the pre-treatment measurement, and a follow-up measurement three months after
      the post-treatment measurement.

      This research includes a larger number of participants (N = 109) than have been involved in
      previous studies utilising randomised controlled trials in research designs. The research
      generates further information about the effectiveness of dance movement therapy groups in the
      rehabilitation of depression as it was conducted in five cities across Finland. This type of
      multi-centre research can provide a realistic picture of the typical practice of a range of
      dance movement therapists working with participants in various geographic locations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline depressive symptoms (Beck Depression Inventory; BDI) at 10-week post-treatment measurement
time frame: 10 weeks
description: BDI measures depressive symptoms with 21 items. Each item is scored 0-3 and sum scores are calculated on the basis of participants' responses. The total sum score can range from 0 to 63.
measure: Change from post-treatment depressive symptoms (Beck Depression Inventory; BDI) at three-month follow-up measurement
time frame: 3 months
description: The change in depressive symptoms between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
measure: Change from baseline psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at 10-week post-treatment measurement
time frame: 10 weeks
description: The CORE-OM comprises 43 items and four dimensions of well-being, problems, life functioning, and risk for aggressive/suicidal behaviour. Each item is scored from 0 to 4. CORE-OM items are summed and then divided by the number of answered items, which is then multiplied by ten; that is, the total scores ranges from 0 to 40.
measure: Change from post-treatment psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at three-month follow-up measurement
time frame: 3 months
description: The change in psychological distress (CORE-OM) between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
measure: Change from baseline physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at 10-week post-treatment measurement
time frame: 10 weeks
description: SCL-90 uses 90 items to measure nine primary symptomatic dimensions, including somatisation, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The level of distress is scored on a scale from 0 to 4. An average score of the 90 items is calculated, which represents the severity of the participant's symptoms, that is, the Global Severity Index (GSI).
measure: Change from post-treatment physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at three-month follow-up measurement
time frame: 3 months
description: The change in physiological and psychological symptoms (SCL-90) between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
arm group label: Treatment group
arm group type: Experimental
description: The participants in the treatment group were offered 20 Dance movement therapy sessions in addition to standard care.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group continued treatment as usual in the health services.
intervention type: Behavioral
intervention name: Dance Movement Therapy group
description: DMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks.
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Raimo Lappalainen, Professor
role: Principal Investigator
affiliation: University of Jyvaskyla
url: https://www.jyu.fi/edupsy/fi/laitokset/psykologia/tutkimus/tutkimusalueet/kliininen-psykologia-ja-psykoterapia/ryhmamuotoinen-tanssi-liiketerapia-kuntoutusmuotona-masennuspotilaille
description: Research project website
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No