<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/NCT01667822</url>
  </required_header>
  <id_info>
    <org_study_id>Self help CBT</org_study_id>
    <nct_id>NCT01667822</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from&#xD;
      mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy&#xD;
      (CBT) has been shown to be an effective treatment of these disorders. Despite the strong&#xD;
      evidence for CBT there is a lack of evidence-based psychological treatment in primary care.&#xD;
      For various reasons, the progress of research has not affected clinical practice. For&#xD;
      successful implementation of CBT in primary care cost-effective therapies, access to&#xD;
      therapists with proper training and supervision, evidence-based manuals and management that&#xD;
      support the implementation is needed.&#xD;
&#xD;
      Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All&#xD;
      patients are first treated with self-help CBT (N = 400). Patients that do not improve after&#xD;
      treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based&#xD;
      on published studies 2/3 is expected to be improved after self-help and therefore do not&#xD;
      undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to&#xD;
      individual CBT (N = 67) or continued self-help treatment (N = 67).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</measure>
    <time_frame>9 weeks</time_frame>
    <description>Absolute improvement, i.e., symptom level below pre-established cut-offs at 9 weeks, 20 weeks, 26 week follow-up, and 52 week follow-up compared to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</measure>
    <time_frame>20 weeks</time_frame>
    <description>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</measure>
    <time_frame>26 weeks</time_frame>
    <description>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</measure>
    <time_frame>52 weeks</time_frame>
    <description>Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work ability index (WAI)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Anxiety Inventory (HAI)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Inventory (QOLI)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up</time_frame>
    <description>Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 dimension (EQ5D)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scales (SDS)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated health 5 (SRH-5)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive Compulsive Inventory-Revised (OCI-R)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liebowitz Social Anxiety Scale Self-report (LSAS-SR)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale Self-rated (PDSS-SR)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn-State Worry Questionnaire (PSWQ)</measure>
    <time_frame>Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Inflammatory cytokines</measure>
    <time_frame>Baseline, post-treatment (20 weeks)</time_frame>
    <description>Change in inflammatory cytokines at post-treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">396</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Major Depression</condition>
  <condition>Stress Disorders</condition>
  <condition>Primary Insomnia</condition>
  <arm_group>
    <arm_group_label>Continued guided self help CBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT individual therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Continued self help CBT</intervention_name>
    <description>After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.</description>
    <arm_group_label>Continued guided self help CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual CBT</intervention_name>
    <description>After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.</description>
    <arm_group_label>CBT individual therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia,&#xD;
             panic disorder, generalized anxiety disorder), or/and major depression, or/and&#xD;
             maladaptive stress reaction, or/and primary insomnia Clinician severity rating scale&#xD;
             2-6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A higher score than 6 on the Clinician severity rating scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karolinska Institutet and Gustavsberg primary care center</name>
      <address>
        <city>Stockholm,</city>
        <state>Stockholm</state>
        <zip>13440</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>October 14, 2016</last_update_submitted>
  <last_update_submitted_qc>October 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Erik Hedman</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT01667822
org study id: Self help CBT
nct id: NCT01667822
lead sponsor: 
collaborator: 
has dmc: No
Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from
      mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy
      (CBT) has been shown to be an effective treatment of these disorders. Despite the strong
      evidence for CBT there is a lack of evidence-based psychological treatment in primary care.
      For various reasons, the progress of research has not affected clinical practice. For
      successful implementation of CBT in primary care cost-effective therapies, access to
      therapists with proper training and supervision, evidence-based manuals and management that
      support the implementation is needed.

      Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All
      patients are first treated with self-help CBT (N = 400). Patients that do not improve after
      treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based
      on published studies 2/3 is expected to be improved after self-help and therefore do not
      undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to
      individual CBT (N = 67) or continued self-help treatment (N = 67).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
time frame: 9 weeks
description: Absolute improvement, i.e., symptom level below pre-established cut-offs at 9 weeks, 20 weeks, 26 week follow-up, and 52 week follow-up compared to baseline.
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
time frame: 20 weeks
description: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
time frame: 26 weeks
description: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
time frame: 52 weeks
description: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
measure: Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Work ability index (WAI)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up
measure: Insomnia Severity Index (ISI)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Health Anxiety Inventory (HAI)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Perceived Stress Scale (PSS)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Quality of Life Inventory (QOLI)
time frame: Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up
description: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
measure: EuroQol-5 dimension (EQ5D)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Sheehan Disability Scales (SDS)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
measure: Self-rated health 5 (SRH-5)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Panic Disorder Severity Scale Self-rated (PDSS-SR)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Penn-State Worry Questionnaire (PSWQ)
time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
description: Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Inflammatory cytokines
time frame: Baseline, post-treatment (20 weeks)
description: Change in inflammatory cytokines at post-treatment
arm group label: Continued guided self help CBT
arm group type: Active Comparator
description: Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total).
arm group label: CBT individual therapy
arm group type: Experimental
description: After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.
intervention type: Behavioral
intervention name: Continued self help CBT
description: After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
arm group label: Continued guided self help CBT
intervention type: Behavioral
intervention name: Individual CBT
description: After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.
arm group label: CBT individual therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Erik Hedman
investigator title: Principal investigator
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Anxiety Disorders