<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/NCT01681771</url>
  </required_header>
  <id_info>
    <org_study_id>FORSS-221791</org_study_id>
    <nct_id>NCT01681771</nct_id>
  </id_info>
  <brief_title>Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression</brief_title>
  <official_title>Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression A Randomised Controlled Study of Short and Long Term Effects on Depressive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</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 purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term&#xD;
      effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on&#xD;
      depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in&#xD;
      patients with chronic heart failure and depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Depressive Symptoms</measure>
    <time_frame>9 weeks</time_frame>
    <description>Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score &gt;10 indicate at least moderate depression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Heart Failure</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Cogntive behaviour therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internet based Cognitive behaviour therapy during 9 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discussion group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Internet moderated discussion group during 9 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behaviour therapy</intervention_name>
    <description>Internet based, weekly home task and weekly feedback provided by health care professional.</description>
    <arm_group_label>Cogntive behaviour therapy</arm_group_label>
    <arm_group_label>Discussion group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Discussion group</intervention_name>
    <description>Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.</description>
    <arm_group_label>Discussion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  have time to participate in the study,&#xD;
&#xD;
          -  treatment for HF according to the European Society of Cardiology guidelines2&#xD;
&#xD;
          -  stable HF (NYHA class I-III) and not being hospitalized for HF the latest month&#xD;
&#xD;
          -  signs of suffering of depressive symptoms (Patient Health Questionnaire-9 &gt;9 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe HF (NYHA IV) or another severe chronic life threatening disease.&#xD;
&#xD;
          -  severe depression assessed to need hospital care&#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>Peter Johansson, Assoc. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Deparment of Cardiology, University Hospital of Linköping</name>
      <address>
        <city>Linköping</city>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <results_first_submitted>October 25, 2017</results_first_submitted>
  <results_first_submitted_qc>February 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2019</results_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Peter Johansson</investigator_full_name>
    <investigator_title>Nurse, Assoc. Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recrutiment from medical clinics</recruitment_details>
      <pre_assignment_details>No pre-assignment details to report</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cogntive Behaviour Therapy</title>
          <description>Internet based Cognitive behaviour therapy during 9 weeks&#xD;
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.</description>
        </group>
        <group group_id="P2">
          <title>Discussion Group</title>
          <description>Internet moderated discussion group during 9 weeks&#xD;
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.&#xD;
Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cogntive Behaviour Therapy</title>
          <description>Internet based Cognitive behaviour therapy during 9 weeks&#xD;
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.</description>
        </group>
        <group group_id="B2">
          <title>Discussion Group</title>
          <description>Internet moderated discussion group during 9 weeks&#xD;
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.&#xD;
Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.6" spread="13.9"/>
                    <measurement group_id="B2" value="62.3" spread="11.7"/>
                    <measurement group_id="B3" value="62.9" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depressive Symptoms</title>
        <description>Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score &gt;10 indicate at least moderate depression.</description>
        <time_frame>9 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cogntive Behaviour Therapy</title>
            <description>Internet based Cognitive behaviour therapy during 9 weeks&#xD;
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.</description>
          </group>
          <group group_id="O2">
            <title>Discussion Group</title>
            <description>Internet moderated discussion group during 9 weeks&#xD;
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.&#xD;
Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptoms</title>
          <description>Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score &gt;10 indicate at least moderate depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="4.6"/>
                    <measurement group_id="O2" value="9.8" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 weeks</time_frame>
      <desc>Weekly measurement of depression to asses if participants depression not deteroriated and became severe requiring contact with a health care providor</desc>
      <group_list>
        <group group_id="E1">
          <title>Cognitive Behavoural Therapy</title>
        </group>
        <group group_id="E2">
          <title>Discussion Group</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. RN Peter Johansson</name_or_title>
      <organization>Linköping University, Department of social and welfare studies. Linköping University</organization>
      <phone>+4613313685</phone>
      <email>peter.b.johansson@liu.se</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01681771
org study id: FORSS-221791
nct id: NCT01681771
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term
      effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on
      depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in
      patients with chronic heart failure and depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Depressive Symptoms
time frame: 9 weeks
description: Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score >10 indicate at least moderate depression.
arm group label: Cogntive behaviour therapy
arm group type: Experimental
description: Internet based Cognitive behaviour therapy during 9 weeks
arm group label: Discussion group
arm group type: Active Comparator
description: Internet moderated discussion group during 9 weeks
intervention type: Behavioral
intervention name: Cognitive behaviour therapy
description: Internet based, weekly home task and weekly feedback provided by health care professional.
arm group label: Cogntive behaviour therapy
arm group label: Discussion group
intervention type: Behavioral
intervention name: Discussion group
description: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
arm group label: Discussion group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Johansson, Assoc. Prof
role: Principal Investigator
affiliation: Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Peter Johansson
investigator title: Nurse, Assoc. Prof
mesh term: Heart Failure
mesh term: Depression
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 