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Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy (Add-CBT)

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ClinicalTrials.gov Identifier: NCT01706731
Recruitment Status : Unknown
Verified October 2012 by Nahathai Wongpakaran, Chiang Mai University.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Nahathai Wongpakaran, Chiang Mai University

Tracking Information
First Submitted Date  ICMJE October 8, 2012
First Posted Date  ICMJE October 15, 2012
Last Update Posted Date October 15, 2012
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
  • Evidence of clinically depression confirmed by clinician [ Time Frame: 2 months after the end of the intervention ]
    Depression will be assessed by HAMD-7 (McIntyre, 2005)
  • Depression- self report [ Time Frame: 2 month after the end of the inetrvention ]
    depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
  • Dimensional psychological distress (anxiety, depression,and somatization) [ Time Frame: week 6, 12, 20 ]
    anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),
  • Dimensional psychological distress ( perception of stress) [ Time Frame: Week 6, 12, 20 ]
    Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 12, 2012)
  • working alliance [ Time Frame: after session 3, 6, and 12 ]
    Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)
  • Pretreatment measure (attachment) [ Time Frame: at baseline ]
    The part includes participants' attachment which will be assessed by the revised Experience of Close Relationships Questionnaire (ECR-R 18)(Wongpakaran, 2012)
  • Pretreatment measure (interpersonal problems) [ Time Frame: at baseline ]
    Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)
  • Pretreatment measure(neuroticism) [ Time Frame: at baseline ]
    Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy
Official Title  ICMJE A Randomized Controlled Trial of Cognitive Behavior Therapy Provided by Buddhist Monks vs. Treatment as Usual in the Treatment of Late Life-depression
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Behavioral: Treatment as usual
    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.
    Other Name: TAU
  • Behavioral: Cognitive-behavioral therapy
    Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.
Study Arms  ICMJE
  • Active Comparator: TAU plus Cognitive-behavioral Therapy
    Participants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks.
    Interventions:
    • Behavioral: Treatment as usual
    • Behavioral: Cognitive-behavioral therapy
  • Sham Comparator: TAU plus routine counselling
    Participants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks.
    Intervention: Behavioral: Treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 12, 2012)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet criteria for Major depressive disorder
  • receiving antidepressant

Exclusion Criteria:

  • presence of intense suicidal intent behaviors that require inpatient admission
  • history of alcohol or drug dependence
  • presence of hallucinations or delusions
  • currently receiving electroconvulsive therapy or repetitive-transcranial magnetic stimulation,
  • patients' involvement in other clinical trials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01706731
Other Study ID Numbers  ICMJE 918
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nahathai Wongpakaran, Chiang Mai University
Study Sponsor  ICMJE Chiang Mai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nahathai - Wongpakaran, M.D. Chiang Mai University
PRS Account Chiang Mai University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP