<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/NCT04442893</url>
  </required_header>
  <id_info>
    <org_study_id>YM108038F</org_study_id>
    <nct_id>NCT04442893</nct_id>
  </id_info>
  <brief_title>Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy in Patients With Schizophrenia</brief_title>
  <official_title>Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bali Psychiatric Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Yang Ming University</source>
  <oversight_info>
    <has_dmc>Yes</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 study will explore the effect of Rumination-Focused Cognitive Behaviour Therapy on&#xD;
      depressive symptoms in patients with schizophrenia for three months. A randomized controlled&#xD;
      trial is conducted in a psychiatric center in northern Taiwan. All participants are&#xD;
      randomized to two groups using blocked randomization. The experimental groups are provided&#xD;
      with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the&#xD;
      control groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once&#xD;
      every two weeks). All participants who suffered from depressive symptoms at both baseline and&#xD;
      3-month follow-up will be evaluated using the Beck Depression Inventory(BDI-II), Chinese&#xD;
      Response Style Questionnaire-short form revised(CRSQ-10), Internalized Stigma of Mental&#xD;
      Illness (ISMI) Scale, and Herth Hope Index Chinese Version(HHI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Depressive symptoms are one of the core symptoms in patients with schizophrenia, but the&#xD;
      effect of depressive symptoms on patients is easily overlooked. Severe depressive symptoms in&#xD;
      patients with schizophrenia are not only affecting the quality of life but also the risk&#xD;
      factors of suicide.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The investigators hypothesize that Rumination-Focused Cognitive Behaviour Therapy(RFCBT)&#xD;
      could have significant effect of depressive symptoms. Therefore, in this study, the&#xD;
      investigators will explore the effect of Rumination-Focused Cognitive Behaviour&#xD;
      Therapy(RFCBT) on depressive symptoms in patients with schizophrenia.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The study is conducted as a two-arm, single-blinded, randomized controlled trial in a&#xD;
      psychiatric center in northern Taiwan. Participants are randomly allocated in a 1:1 ratio to&#xD;
      two groups using blocked randomization. The experimental groups are provided with a 6-&#xD;
      session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the control&#xD;
      groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two&#xD;
      weeks) .&#xD;
&#xD;
      Participants and demographic data:&#xD;
&#xD;
      Participants who have been diagnosed with schizophrenia according to DSM-IV criteria took&#xD;
      part in the study after informed consent is obtained. All participants are 20 years of age or&#xD;
      older and are receiving a stable dosage of antipsychotics, and have no history of cognitive&#xD;
      impairment. The participants are able to express themselves and to individually complete the&#xD;
      Beck Depression Inventory(BDI-II), Chinese Response Style Questionnaire-short form&#xD;
      revised(CRSQ-10), Internalized Stigma of Mental Illness (ISMI) Scale, and Herth Hope Index&#xD;
      Chinese Version(HHI).&#xD;
&#xD;
      Measures:&#xD;
&#xD;
      The demographic characteristics include five continuous variables (age, age at onset,&#xD;
      duration of disease, years of education, chlorpromazine equivalent dose (Andreasen, Pressler,&#xD;
      Nopoulos, Miller, &amp; Ho, 2010) and four categorical variables (sex, marital status, work&#xD;
      status, antidepressants).&#xD;
&#xD;
      Procedure and Data collection:&#xD;
&#xD;
      All procedures are approved by both national Ying Ming university(IRB YM108038F) and the&#xD;
      psychiatric center (IRB 1080009-01). Following informed consent, each participant will fill&#xD;
      out a demographic questionnaire and complete the BDI-II, CRHQ-10, ISMIS, and HHI once at&#xD;
      baseline and twice an interval of three months. A well-trained and licensed psychiatric nurse&#xD;
      will perform the data collection and assists the participants if there were difficulties&#xD;
      reading or understanding the questionnaires.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      This study will employ Predictive Analytics Suite Workstation (IBM SPSS 24.0) to analyze the&#xD;
      collected data. The data analyses will include demographic variables and the scores of&#xD;
      BDI-II, CRHQ-10, ISMIS, and HHI at the interval of three months of all of the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2019</start_date>
  <completion_date type="Actual">March 16, 2020</completion_date>
  <primary_completion_date type="Actual">August 18, 2019</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>
    <intervention_model_description>The participants were divided into experimental and control groups through block randomization</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The data of PANSS were collected by a research assistant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Beck Depression Inventory (BDI-II)</measure>
    <time_frame>3 months</time_frame>
    <description>The Beck Depression Inventory-II (BDI-II) is a 21-item self-report depression screening measure (Beck, Steer, Ball, &amp; Ranieri, 1996). Each item is rated on a four-point Likert-type scale ranging from 0 to 3, which with possible scores ranging from 0 to 63. The BDI-II has been translated into a Chinese version (Chen, 2000). Higher total scores indicate more severe depressive symptoms, and a score of &gt;16 points is considered suggestive of the presence of clinically significant depressive symptom intensity (Lu, Che, Chang, &amp; Shen, 2002).&#xD;
In this study, the investigators will explore the change of BDI-II score between baseline and three-month follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chinese Response Style Questionnaire-short form revised (CRSQ-10)</measure>
    <time_frame>3 months</time_frame>
    <description>The Chinese Response Style Questionnaire-short form revised (CRSQ-10) is a self-report measure of rumination, comprising ten items and describing the factors of brooding and reflection (Chow, 2008). Each item is rated on a four-point Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 10 to 40. The CRSQ-10 has been used to evaluate the intensity of ruminative responses to depressed mood.&#xD;
In this study, the investigators will explore the change of CRSQ-10 score between baseline and three-month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Internalized Stigma of Mental Illness (ISMI) Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Internalized Stigma of Mental Illness (ISMI) Scale is a 29-item self-report questionnaire measuring self-stigma among persons with psychiatric disorders (Ritsher, Otilingam, &amp; Grajales, 2003). Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 29 to 116. The ISMI Scale has been translated into a Chinese version (Chang, Wu, Chen, Wang, &amp; Lin, 2014). Higher scores indicating greater self-stigma.&#xD;
In this study, the investigators will explore the change of ISMI Scale score between baseline and three-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Herth Hope Index Chinese Version(HHI)</measure>
    <time_frame>3 months</time_frame>
    <description>The Herth Hope Index (HHI) comprises 12-item self-report measure of hopefulness (Herth, 1992). Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 12 to 48. The HHI has been translated into a Chinese version (Chen, &amp; Wang, 1997). Higher scores indicating greater hopefulness.&#xD;
In this study, the investigators will explore the change of HHI score between baseline and three-month follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Randomized Controlled Trial</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rumination-Focused Cognitive Behaviour Therapy</intervention_name>
    <description>Rumination-Focused Cognitive Behavioural Therapy(RFCBT) is based on a differentiation between functional and dysfunctional styles of perseverative thinking with the helpful style characterized as a concrete, process-focused and specific style of thinking and the idea that rumination is a habit maintained by negative reinforcement. In line with the theoretical assumptions, RFCBT combines strategies from behavioral activation with strategies to foster concrete, process-focused and specific thinking.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Education programme</intervention_name>
    <description>Health education programme would be any planned activity or set of activities aimed at increasing health literacy and developing life skills conducing to health (e.g. decision making, problem solving, critical thinking, interpersonal skills, stress management, coping with emotions).</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participants are diagnosed with schizophrenia by Diagnostic and Statistical Manual&#xD;
             of Mental Disorders, Five Edition (DSM-V), an age of between 20 and 65 years,&#xD;
             hospitalization in a rehabilitation unit, and a stable condition at the time of data&#xD;
             collection.&#xD;
&#xD;
          -  The participants are able to provide written informed consent and comprehend the&#xD;
             instruments.&#xD;
&#xD;
          -  The participants consent to receive a 6- session RFCBT program or a 6- session Health&#xD;
             Education program and complete a package of questionnaires.&#xD;
&#xD;
          -  The participants are satisfied the screening criteria including the Positive and&#xD;
             Negative Syndrome Scale (PANSS) for positive syndromes &lt; 5, the Mini-Mental State&#xD;
             Examination (MMSE) ≥ 24, and the Brief Symptom Rating Scale (BSRS-5) ≥ 6.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participants who have intellectual disturbances (organic mental disorders) or&#xD;
             substance abuse issues through a chart review.&#xD;
&#xD;
          -  The participants who are not willing to sign the consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chiu-Yueh Yang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Yang Ming University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Yang-Ming University</name>
      <address>
        <city>Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 2, 2019</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Chiu-Yueh Yang</investigator_full_name>
    <investigator_title>Associate Professor, Nursing Department</investigator_title>
  </responsible_party>
  <keyword>Rumination-Focused Cognitive Behaviour Therapy(RFCBT)</keyword>
  <keyword>depressive symptom</keyword>
  <keyword>Schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rumination Syndrome</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 24, 2020</submitted>
    <returned>September 11, 2020</returned>
    <submitted>October 16, 2021</submitted>
    <returned>November 12, 2021</returned>
    <submitted>November 14, 2021</submitted>
    <returned>January 14, 2022</returned>
  </pending_results>
  <!-- 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/NCT04442893
org study id: YM108038F
nct id: NCT04442893
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will explore the effect of Rumination-Focused Cognitive Behaviour Therapy on
      depressive symptoms in patients with schizophrenia for three months. A randomized controlled
      trial is conducted in a psychiatric center in northern Taiwan. All participants are
      randomized to two groups using blocked randomization. The experimental groups are provided
      with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the
      control groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once
      every two weeks). All participants who suffered from depressive symptoms at both baseline and
      3-month follow-up will be evaluated using the Beck Depression Inventory(BDI-II), Chinese
      Response Style Questionnaire-short form revised(CRSQ-10), Internalized Stigma of Mental
      Illness (ISMI) Scale, and Herth Hope Index Chinese Version(HHI).
Background:

      Depressive symptoms are one of the core symptoms in patients with schizophrenia, but the
      effect of depressive symptoms on patients is easily overlooked. Severe depressive symptoms in
      patients with schizophrenia are not only affecting the quality of life but also the risk
      factors of suicide.

      Aim:

      The investigators hypothesize that Rumination-Focused Cognitive Behaviour Therapy(RFCBT)
      could have significant effect of depressive symptoms. Therefore, in this study, the
      investigators will explore the effect of Rumination-Focused Cognitive Behaviour
      Therapy(RFCBT) on depressive symptoms in patients with schizophrenia.

      Methods:

      The study is conducted as a two-arm, single-blinded, randomized controlled trial in a
      psychiatric center in northern Taiwan. Participants are randomly allocated in a 1:1 ratio to
      two groups using blocked randomization. The experimental groups are provided with a 6-
      session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the control
      groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two
      weeks) .

      Participants and demographic data:

      Participants who have been diagnosed with schizophrenia according to DSM-IV criteria took
      part in the study after informed consent is obtained. All participants are 20 years of age or
      older and are receiving a stable dosage of antipsychotics, and have no history of cognitive
      impairment. The participants are able to express themselves and to individually complete the
      Beck Depression Inventory(BDI-II), Chinese Response Style Questionnaire-short form
      revised(CRSQ-10), Internalized Stigma of Mental Illness (ISMI) Scale, and Herth Hope Index
      Chinese Version(HHI).

      Measures:

      The demographic characteristics include five continuous variables (age, age at onset,
      duration of disease, years of education, chlorpromazine equivalent dose (Andreasen, Pressler,
      Nopoulos, Miller, & Ho, 2010) and four categorical variables (sex, marital status, work
      status, antidepressants).

      Procedure and Data collection:

      All procedures are approved by both national Ying Ming university(IRB YM108038F) and the
      psychiatric center (IRB 1080009-01). Following informed consent, each participant will fill
      out a demographic questionnaire and complete the BDI-II, CRHQ-10, ISMIS, and HHI once at
      baseline and twice an interval of three months. A well-trained and licensed psychiatric nurse
      will perform the data collection and assists the participants if there were difficulties
      reading or understanding the questionnaires.

      Statistical analysis:

      This study will employ Predictive Analytics Suite Workstation (IBM SPSS 24.0) to analyze the
      collected data. The data analyses will include demographic variables and the scores of
      BDI-II, CRHQ-10, ISMIS, and HHI at the interval of three months of all of the participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The participants were divided into experimental and control groups through block randomization
primary purpose: Supportive Care
masking: Single (Participant)
masking description: The data of PANSS were collected by a research assistant.
measure: Beck Depression Inventory (BDI-II)
time frame: 3 months
description: The Beck Depression Inventory-II (BDI-II) is a 21-item self-report depression screening measure (Beck, Steer, Ball, & Ranieri, 1996). Each item is rated on a four-point Likert-type scale ranging from 0 to 3, which with possible scores ranging from 0 to 63. The BDI-II has been translated into a Chinese version (Chen, 2000). Higher total scores indicate more severe depressive symptoms, and a score of >16 points is considered suggestive of the presence of clinically significant depressive symptom intensity (Lu, Che, Chang, & Shen, 2002).
In this study, the investigators will explore the change of BDI-II score between baseline and three-month follow-up.
measure: Chinese Response Style Questionnaire-short form revised (CRSQ-10)
time frame: 3 months
description: The Chinese Response Style Questionnaire-short form revised (CRSQ-10) is a self-report measure of rumination, comprising ten items and describing the factors of brooding and reflection (Chow, 2008). Each item is rated on a four-point Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 10 to 40. The CRSQ-10 has been used to evaluate the intensity of ruminative responses to depressed mood.
In this study, the investigators will explore the change of CRSQ-10 score between baseline and three-month follow-up.
measure: The Internalized Stigma of Mental Illness (ISMI) Scale
time frame: 3 months
description: The Internalized Stigma of Mental Illness (ISMI) Scale is a 29-item self-report questionnaire measuring self-stigma among persons with psychiatric disorders (Ritsher, Otilingam, & Grajales, 2003). Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 29 to 116. The ISMI Scale has been translated into a Chinese version (Chang, Wu, Chen, Wang, & Lin, 2014). Higher scores indicating greater self-stigma.
In this study, the investigators will explore the change of ISMI Scale score between baseline and three-month follow-up.
measure: Herth Hope Index Chinese Version(HHI)
time frame: 3 months
description: The Herth Hope Index (HHI) comprises 12-item self-report measure of hopefulness (Herth, 1992). Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 12 to 48. The HHI has been translated into a Chinese version (Chen, & Wang, 1997). Higher scores indicating greater hopefulness.
In this study, the investigators will explore the change of HHI score between baseline and three-month follow-up.
arm group label: Experimental group
arm group type: Experimental
description: The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
arm group label: Control group
arm group type: Other
description: The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
intervention type: Behavioral
intervention name: Rumination-Focused Cognitive Behaviour Therapy
description: Rumination-Focused Cognitive Behavioural Therapy(RFCBT) is based on a differentiation between functional and dysfunctional styles of perseverative thinking with the helpful style characterized as a concrete, process-focused and specific style of thinking and the idea that rumination is a habit maintained by negative reinforcement. In line with the theoretical assumptions, RFCBT combines strategies from behavioral activation with strategies to foster concrete, process-focused and specific thinking.
arm group label: Experimental group
intervention type: Other
intervention name: Health Education programme
description: Health education programme would be any planned activity or set of activities aimed at increasing health literacy and developing life skills conducing to health (e.g. decision making, problem solving, critical thinking, interpersonal skills, stress management, coping with emotions).
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chiu-Yueh Yang, PhD
role: Principal Investigator
affiliation: National Yang Ming University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Chiu-Yueh Yang
investigator title: Associate Professor, Nursing Department
mesh term: Rumination Syndrome
mesh term: Schizophrenia
submitted: August 24, 2020
returned: September 11, 2020
submitted: October 16, 2021
returned: November 12, 2021
submitted: November 14, 2021
returned: January 14, 2022