<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/NCT03795480</url>
  </required_header>
  <id_info>
    <org_study_id>MOOD</org_study_id>
    <nct_id>NCT03795480</nct_id>
  </id_info>
  <brief_title>Online Intervention for Depression: MOOD</brief_title>
  <acronym>MOOD</acronym>
  <official_title>A Randomized-controlled Trial (RCT) on the Efficacy of a New Online Intervention for Depression: MOOD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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 study aims to examine the efficacy and acceptance of a self-help internet intervention&#xD;
      &quot;MOOD&quot; in a sample of individuals with depressive symptoms. It is tested whether depressive&#xD;
      symptomatology decreases in the intervention group compared to a wait-list control group.&#xD;
      Further aims are to ascertain changes in self-worth and quality of life, to assess subjective&#xD;
      evaluation of the program and to examine whether expectations of the program's helpfulness&#xD;
      would predict symptom reduction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to examine the efficacy and acceptance of a self-help internet intervention&#xD;
      &quot;MOOD&quot; in a sample of individuals with depressive symptoms. It is tested whether depressive&#xD;
      symptomatology decreases in the intervention group compared to a wait-list control group.&#xD;
      Secondary aims are to ascertain changes in self-worth and quality of life, to assess&#xD;
      subjective evaluation of the program and to examine whether expectations of the program's&#xD;
      helpfulness would predict symptom reduction. During the intervention period of six weeks,&#xD;
      participants of the intervention group have access to the online program MOOD. Prior and&#xD;
      following this period both groups complete a pre- and post-assessment. Participants of the&#xD;
      wait-list control group receive access to MOOD following the post-assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2018</start_date>
  <completion_date type="Actual">July 22, 2018</completion_date>
  <primary_completion_date type="Actual">July 22, 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>Beck Depression Inventory (BDI)</measure>
    <time_frame>Change in BDI from baseline to post (intervention period is 6 weeks)</time_frame>
    <description>This questionnaire assesses symptoms of depression and their severity (Beck, Steer, &amp; Brown, 1996). It contains 21 items and the participant is asked to rate how severe he or she experiences each symptom on a 4-point Likert scale ranging from 0 (not at all severe) to 3 (extreme form of each symptom).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rosenberg self-esteem scale (RSE)</measure>
    <time_frame>Change in RSE from baseline to post (intervention period is 6 weeks)</time_frame>
    <description>The RSE is a self-report questionnaire assessing an individual's self-esteem (Rosenberg, 1965) The scale consists of 10 items and the participants are asked to rate in how far they agree with each item on a 4-point Likert scale ranging from &quot;strongly disagree&quot; to &quot;strongly agree&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL-Bref</measure>
    <time_frame>Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks)</time_frame>
    <description>The WHOQOL-Bref is a questionnaire assessing Quality of Life (QOL) (Whoqol Group, 1998). It is an abbreviated version of the WHOQOL-100 and contains 26 items. The questionnaire has four types of 5-point Likert scales asking the participant &quot;how much&quot;, &quot;how completely&quot;, &quot;how often&quot;, &quot;how good&quot; or &quot;how satisfied&quot; he felt in the last two weeks. The four different scales are distributed across the four domains sampled in this questionnaire: Physical health, Psychological, Social relations, Environment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>University of Rhode Island Change Assessment (URICA)</measure>
    <time_frame>Only at Baseline (pre intervention)</time_frame>
    <description>The URICA is a measure of willingness to change (Dozois, Westra, Collins, Fung &amp; Garry, 2004) and was assessed at baseline. It consists of 32 items that depict four stages of change: pre-contemplation, contemplation, action and maintenance. In the present study, in total 9 items are used which were chosen from the subscales of pre-contemplation, contemplation and action. Internal consistency is .83 and test-retest reliability lies between .63-.75.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective appraisal</measure>
    <time_frame>Only at post-assessment (6 weeks)</time_frame>
    <description>In the post-assessment, individuals of the intervention group also answered questions on subjective evaluation and appraisal of the program. Items were for example &quot;I think this program is useful as a self-help tool&quot; or &quot;I had to bring myself to make use of the program&quot;. The items could be answered on a 4-point Likert scale ranging from &quot;Totally disagree&quot; to &quot;Totally agree&quot;. Participants also had the possibility to provide feedback on the program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 Depression Module (PHQ-9)</measure>
    <time_frame>Change in PHQ-9 from baseline to post (intervention period is 6 weeks)</time_frame>
    <description>The PHQ-9 is used to measure depression and its severity (Kroenke, Spitzer, &amp; Williams, 2001). It consists of 9 items which can be rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), depending on the severity and frequency of the symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>MOOD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The online program &quot;MOOD&quot; is based on methods of cognitive behavior therapy (KVT) and contains elements of mindfulness and metacognition. Participants can contact a moderator (trained psychologists) if they have any questions. However, this function is optional. The program consists of nine interactive modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The wait-list control group does not receive additional treatment. However, previously started therapies (psychotherapy/ psychopharmacotherapy) may be continued during the study. Individuals of the wait-list control group receive access to MOOD after completion of the post-assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOOD</intervention_name>
    <description>MOOD is an online self-help program targeted on depressive symptoms. The program consists of nine modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. All modules are based on principles of cognitive behavioral therapy (CBT) and include elements of mindfulness-based and metacognitive techniques. The modules contain interactive exercises which are aimed at incorporating the participant's experiences into the program and increasing identification of the participant with the presented material. Participants are free to work through the different modules in their own speed and way, however, it is recommended to work on one to two modules per week.</description>
    <arm_group_label>MOOD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of psychological strain and desire for treatment for depressive symptoms&#xD;
&#xD;
          -  internet access&#xD;
&#xD;
          -  sufficient command of the German language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute suicidality (as assessed with one item of the BDI)&#xD;
&#xD;
          -  lifetime diagnoses of bipolar disorder and psychosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steffen Moritz, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department for Psychiatry and Psychotherapy of University Medical Center Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 16, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03795480
org study id: MOOD
nct id: NCT03795480
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to examine the efficacy and acceptance of a self-help internet intervention
      "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive
      symptomatology decreases in the intervention group compared to a wait-list control group.
      Further aims are to ascertain changes in self-worth and quality of life, to assess subjective
      evaluation of the program and to examine whether expectations of the program's helpfulness
      would predict symptom reduction.
The study aims to examine the efficacy and acceptance of a self-help internet intervention
      "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive
      symptomatology decreases in the intervention group compared to a wait-list control group.
      Secondary aims are to ascertain changes in self-worth and quality of life, to assess
      subjective evaluation of the program and to examine whether expectations of the program's
      helpfulness would predict symptom reduction. During the intervention period of six weeks,
      participants of the intervention group have access to the online program MOOD. Prior and
      following this period both groups complete a pre- and post-assessment. Participants of the
      wait-list control group receive access to MOOD following the post-assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Beck Depression Inventory (BDI)
time frame: Change in BDI from baseline to post (intervention period is 6 weeks)
description: This questionnaire assesses symptoms of depression and their severity (Beck, Steer, & Brown, 1996). It contains 21 items and the participant is asked to rate how severe he or she experiences each symptom on a 4-point Likert scale ranging from 0 (not at all severe) to 3 (extreme form of each symptom).
measure: Rosenberg self-esteem scale (RSE)
time frame: Change in RSE from baseline to post (intervention period is 6 weeks)
description: The RSE is a self-report questionnaire assessing an individual's self-esteem (Rosenberg, 1965) The scale consists of 10 items and the participants are asked to rate in how far they agree with each item on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree".
measure: WHOQOL-Bref
time frame: Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks)
description: The WHOQOL-Bref is a questionnaire assessing Quality of Life (QOL) (Whoqol Group, 1998). It is an abbreviated version of the WHOQOL-100 and contains 26 items. The questionnaire has four types of 5-point Likert scales asking the participant "how much", "how completely", "how often", "how good" or "how satisfied" he felt in the last two weeks. The four different scales are distributed across the four domains sampled in this questionnaire: Physical health, Psychological, Social relations, Environment.
measure: University of Rhode Island Change Assessment (URICA)
time frame: Only at Baseline (pre intervention)
description: The URICA is a measure of willingness to change (Dozois, Westra, Collins, Fung & Garry, 2004) and was assessed at baseline. It consists of 32 items that depict four stages of change: pre-contemplation, contemplation, action and maintenance. In the present study, in total 9 items are used which were chosen from the subscales of pre-contemplation, contemplation and action. Internal consistency is .83 and test-retest reliability lies between .63-.75.
measure: Subjective appraisal
time frame: Only at post-assessment (6 weeks)
description: In the post-assessment, individuals of the intervention group also answered questions on subjective evaluation and appraisal of the program. Items were for example "I think this program is useful as a self-help tool" or "I had to bring myself to make use of the program". The items could be answered on a 4-point Likert scale ranging from "Totally disagree" to "Totally agree". Participants also had the possibility to provide feedback on the program.
measure: Patient Health Questionnaire-9 Depression Module (PHQ-9)
time frame: Change in PHQ-9 from baseline to post (intervention period is 6 weeks)
description: The PHQ-9 is used to measure depression and its severity (Kroenke, Spitzer, & Williams, 2001). It consists of 9 items which can be rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), depending on the severity and frequency of the symptoms.
arm group label: MOOD
arm group type: Experimental
description: The online program "MOOD" is based on methods of cognitive behavior therapy (KVT) and contains elements of mindfulness and metacognition. Participants can contact a moderator (trained psychologists) if they have any questions. However, this function is optional. The program consists of nine interactive modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention.
arm group label: Control
arm group type: No Intervention
description: The wait-list control group does not receive additional treatment. However, previously started therapies (psychotherapy/ psychopharmacotherapy) may be continued during the study. Individuals of the wait-list control group receive access to MOOD after completion of the post-assessment.
intervention type: Behavioral
intervention name: MOOD
description: MOOD is an online self-help program targeted on depressive symptoms. The program consists of nine modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. All modules are based on principles of cognitive behavioral therapy (CBT) and include elements of mindfulness-based and metacognitive techniques. The modules contain interactive exercises which are aimed at incorporating the participant's experiences into the program and increasing identification of the participant with the presented material. Participants are free to work through the different modules in their own speed and way, however, it is recommended to work on one to two modules per week.
arm group label: MOOD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steffen Moritz, Prof.
role: Principal Investigator
affiliation: Universitätsklinikum Hamburg-Eppendorf
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No