<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/NCT01671033</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 09902-006</org_study_id>
    <nct_id>NCT01671033</nct_id>
  </id_info>
  <brief_title>Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring</brief_title>
  <official_title>Muscle Relaxation With Biofeedback Via Internet for Panic disorder-a Randomized Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chimei Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chimei Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      From the scarce literature it showed that computer/internet-aided cognitive behavior therapy&#xD;
      (CBT) was superior to waitlist and placebo assignment across outcome measures, and the&#xD;
      effects of computer/internet-aided CBT were equal to therapist-delivered treatment across&#xD;
      anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based&#xD;
      relaxation with biofeedback treatment for panic disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants had access to a computer with an internet connection and received the&#xD;
      treatment via internet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The drop-out rate was too high.&#xD;
  </why_stopped>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">January 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Score Change of The Panic Disorder Severity Scale(PDSS)</measure>
    <time_frame>Baseline / Week 4/ Week 8/ Week12/ Week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score Change of relaxation-rating</measure>
    <time_frame>Baseline / Week 4/ Week 8/ Week 12/ Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Panic Disorder</condition>
  <arm_group>
    <arm_group_label>Muscle Relaxation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients of this arm practice on-line muscle relaxation every day.They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle Relaxation with Biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-List</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients of this arm waited for four weeks. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR (APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Impressions-Improvement(CGI) were performed by well-trained clinicians.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>Patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.</description>
    <arm_group_label>Muscle Relaxation with Biofeedback</arm_group_label>
    <other_name>finger temperature biofeedback</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscle Relaxation</intervention_name>
    <description>Patients with panic disorder practice muscle relaxation via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.</description>
    <arm_group_label>Muscle Relaxation</arm_group_label>
    <arm_group_label>Muscle Relaxation with Biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The participant must fulfill DSM-IV criteria for panic disorder.&#xD;
&#xD;
          2. The participant must be between 20 and 60 years of age.&#xD;
&#xD;
          3. The participant must have the Panic Disorder Severity Scale(PDSS) score ≧8.&#xD;
&#xD;
          4. If the participant is taking prescribed drugs for panic disorder, a) the dosage have&#xD;
             to be constant for 6 weeks before starting treatment, and b) the participant have to&#xD;
             agree to keep the dosage constant for 2 months after starting treatment.&#xD;
&#xD;
          5. If the participant was already in therapy, the contact must have lasted at least 3&#xD;
             months and not be based on cognitive behavior therapy.&#xD;
&#xD;
          6. All participants have access to a computer with an Internet connection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The participant suffers from any other psychiatric disorder in immediate need of&#xD;
             treatment.&#xD;
&#xD;
          2. The participant fulfills DSM-IV criteria for major depression.&#xD;
&#xD;
          3. The participant has epilepsy, kidney problems, strokes, organic brain syndrome,&#xD;
             emphysema, heart disorders, or chronic hypertension.&#xD;
&#xD;
          4. The participant has alcoholism or substance dependence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fong-Lin Jang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Chimei Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chimei Medical Center</name>
      <address>
        <city>Tainan</city>
        <zip>70246</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2010</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chimei Medical Center</investigator_affiliation>
    <investigator_full_name>Fong-Lin Jang</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Panic disorder</keyword>
  <keyword>cognitive behavior therapy</keyword>
  <keyword>Internet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panic Disorder</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/NCT01671033
org study id: IRB 09902-006
nct id: NCT01671033
lead sponsor: 
collaborator: 
has dmc: Yes
From the scarce literature it showed that computer/internet-aided cognitive behavior therapy
      (CBT) was superior to waitlist and placebo assignment across outcome measures, and the
      effects of computer/internet-aided CBT were equal to therapist-delivered treatment across
      anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based
      relaxation with biofeedback treatment for panic disorder.
All participants had access to a computer with an internet connection and received the
      treatment via internet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Score Change of The Panic Disorder Severity Scale(PDSS)
time frame: Baseline / Week 4/ Week 8/ Week12/ Week 16
measure: Score Change of relaxation-rating
time frame: Baseline / Week 4/ Week 8/ Week 12/ Week 16
arm group label: Muscle Relaxation
arm group type: Experimental
description: The patients of this arm practice on-line muscle relaxation every day.They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.
arm group label: Muscle Relaxation with Biofeedback
arm group type: Experimental
description: The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.
arm group label: Waiting-List
arm group type: No Intervention
description: The patients of this arm waited for four weeks. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR (APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Impressions-Improvement(CGI) were performed by well-trained clinicians.
intervention type: Behavioral
intervention name: Biofeedback
description: Patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.
arm group label: Muscle Relaxation with Biofeedback
other name: finger temperature biofeedback
intervention type: Behavioral
intervention name: Muscle Relaxation
description: Patients with panic disorder practice muscle relaxation via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.
arm group label: Muscle Relaxation
arm group label: Muscle Relaxation with Biofeedback
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Fong-Lin Jang, M.D.
role: Study Director
affiliation: Chimei Medical Center
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chimei Medical Center
investigator full name: Fong-Lin Jang
investigator title: M.D.
mesh term: Panic Disorder