<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/NCT01706731</url>
  </required_header>
  <id_info>
    <org_study_id>918</org_study_id>
    <nct_id>NCT01706731</nct_id>
  </id_info>
  <brief_title>Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy</brief_title>
  <acronym>Add-CBT</acronym>
  <official_title>A Randomized Controlled Trial of Cognitive Behavior Therapy Provided by Buddhist Monks vs. Treatment as Usual in the Treatment of Late Life-depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiang Mai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiang Mai University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is to study the effectiveness of cognitive behavioral therapy-CBT and&#xD;
      Psychotherapy by trained buddhist monks. There are generally accepted that both cognitive and&#xD;
      Buddhist concepts are related. This randomized controlled trial is to study the elderly&#xD;
      participants who suffer major depressive disorder according to DSM-IV. The subjects will be&#xD;
      divided into two groups. The experimental group will receive 12 sessions of CBT 2 times per&#xD;
      week for 6 weeks in addition to usual treatment. The control group will receive treatment as&#xD;
      usual and general conversation (non-CBT) with monks. Pretreatment factors (such as attachment&#xD;
      style, interpersonal factors) of both therapist monks and patient participants will be&#xD;
      studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of clinically depression confirmed by clinician</measure>
    <time_frame>2 months after the end of the intervention</time_frame>
    <description>Depression will be assessed by HAMD-7 (McIntyre, 2005)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression- self report</measure>
    <time_frame>2 month after the end of the inetrvention</time_frame>
    <description>depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh &amp; Yesavage, 1986)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dimensional psychological distress (anxiety, depression,and somatization)</measure>
    <time_frame>week 6, 12, 20</time_frame>
    <description>anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dimensional psychological distress ( perception of stress)</measure>
    <time_frame>Week 6, 12, 20</time_frame>
    <description>Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>working alliance</measure>
    <time_frame>after session 3, 6, and 12</time_frame>
    <description>Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)</description>
  </other_outcome>
  <other_outcome>
    <measure>Pretreatment measure (attachment)</measure>
    <time_frame>at baseline</time_frame>
    <description>The part includes participants' attachment which will be assessed by the revised Experience of Close Relationships Questionnaire (ECR-R 18)(Wongpakaran, 2012)</description>
  </other_outcome>
  <other_outcome>
    <measure>Pretreatment measure (interpersonal problems)</measure>
    <time_frame>at baseline</time_frame>
    <description>Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)</description>
  </other_outcome>
  <other_outcome>
    <measure>Pretreatment measure(neuroticism)</measure>
    <time_frame>at baseline</time_frame>
    <description>Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>TAU plus Cognitive-behavioral Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU plus routine counselling</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Treatment as usual (TAU)is defined as the routine care provided to each individual patient at the geriatric psychiatry clinic of Maharaj Nakorn Chiang Mai Hospital.</description>
    <arm_group_label>TAU plus Cognitive-behavioral Therapy</arm_group_label>
    <arm_group_label>TAU plus routine counselling</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-behavioral therapy</intervention_name>
    <description>Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.</description>
    <arm_group_label>TAU plus Cognitive-behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet criteria for Major depressive disorder&#xD;
&#xD;
          -  receiving antidepressant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of intense suicidal intent behaviors that require inpatient admission&#xD;
&#xD;
          -  history of alcohol or drug dependence&#xD;
&#xD;
          -  presence of hallucinations or delusions&#xD;
&#xD;
          -  currently receiving electroconvulsive therapy or repetitive-transcranial magnetic&#xD;
             stimulation,&#xD;
&#xD;
          -  patients' involvement in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nahathai - Wongpakaran, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chiang Mai University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nahathai - Wongpakaran, M.D.</last_name>
    <phone>+66 53 945422</phone>
    <phone_ext>320</phone_ext>
    <email>nkuntawo@med.cmu.ac.th</email>
  </overall_contact>
  <location>
    <facility>
      <name>Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <investigator>
      <last_name>Tinakon - Wongpakaran, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paritat - Silpakit, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sawaeng - Saenbutra, M.Sc.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manachai - Rodcheun, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Phramahabunchuay - Doojai, M.A.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiang Mai University</investigator_affiliation>
    <investigator_full_name>Nahathai Wongpakaran</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Buddhist monks</keyword>
  <keyword>CBT</keyword>
  <keyword>elderly</keyword>
  <keyword>depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT01706731
org study id: 918
nct id: NCT01706731
lead sponsor: 
has dmc: No
This research is to study the effectiveness of cognitive behavioral therapy-CBT and
      Psychotherapy by trained buddhist monks. There are generally accepted that both cognitive and
      Buddhist concepts are related. This randomized controlled trial is to study the elderly
      participants who suffer major depressive disorder according to DSM-IV. The subjects will be
      divided into two groups. The experimental group will receive 12 sessions of CBT 2 times per
      week for 6 weeks in addition to usual treatment. The control group will receive treatment as
      usual and general conversation (non-CBT) with monks. Pretreatment factors (such as attachment
      style, interpersonal factors) of both therapist monks and patient participants will be
      studied.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Evidence of clinically depression confirmed by clinician
time frame: 2 months after the end of the intervention
description: Depression will be assessed by HAMD-7 (McIntyre, 2005)
measure: Depression- self report
time frame: 2 month after the end of the inetrvention
description: depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)
measure: Dimensional psychological distress (anxiety, depression,and somatization)
time frame: week 6, 12, 20
description: anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),
measure: Dimensional psychological distress ( perception of stress)
time frame: Week 6, 12, 20
description: Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)
measure: working alliance
time frame: after session 3, 6, and 12
description: Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)
measure: Pretreatment measure (attachment)
time frame: at baseline
description: The part includes participants' attachment which will be assessed by the revised Experience of Close Relationships Questionnaire (ECR-R 18)(Wongpakaran, 2012)
measure: Pretreatment measure (interpersonal problems)
time frame: at baseline
description: Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)
measure: Pretreatment measure(neuroticism)
time frame: at baseline
description: Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)
arm group label: TAU plus Cognitive-behavioral Therapy
arm group type: Active Comparator
description: Participants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks.
arm group label: TAU plus routine counselling
arm group type: Sham Comparator
description: Participants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks.
intervention type: Behavioral
intervention name: Treatment as usual
description: Treatment as usual (TAU)is defined as the routine care provided to each individual patient at the geriatric psychiatry clinic of Maharaj Nakorn Chiang Mai Hospital.
arm group label: TAU plus Cognitive-behavioral Therapy
arm group label: TAU plus routine counselling
other name: TAU
intervention type: Behavioral
intervention name: Cognitive-behavioral therapy
description: Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.
arm group label: TAU plus Cognitive-behavioral Therapy
criteria: 
gender: All
minimum age: 60 Years
maximum age: 95 Years
healthy volunteers: No
last name: Nahathai - Wongpakaran, M.D.
role: Principal Investigator
affiliation: Chiang Mai University
last name: Nahathai - Wongpakaran, M.D.
phone: +66 53 945422
phone ext: 320
email: nkuntawo@med.cmu.ac.th
facility: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chiang Mai University
investigator full name: Nahathai Wongpakaran
investigator title: Associate Professor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major