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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Chiang Mai University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Nahathai Wongpakaran, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01706731
First received: October 8, 2012
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Behavioral: Treatment as usual
Behavioral: Cognitive-behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Evidence of clinically depression confirmed by clinician [ Time Frame: 2 months after the end of the intervention ] [ Designated as safety issue: No ]
    Depression will be assessed by HAMD-7 (McIntyre, 2005)

  • Depression- self report [ Time Frame: 2 month after the end of the inetrvention ] [ Designated as safety issue: No ]
    depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)


Secondary Outcome Measures:
  • Dimensional psychological distress (anxiety, depression,and somatization) [ Time Frame: week 6, 12, 20 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)


Other Outcome Measures:
  • working alliance [ Time Frame: after session 3, 6, and 12 ] [ Designated as safety issue: No ]
    Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)

  • Pretreatment measure (attachment) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)

  • Pretreatment measure(neuroticism) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)


Estimated Enrollment: 62
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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

  Eligibility

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706731

Contacts
Contact: Nahathai - Wongpakaran, M.D. +66 53 945422 ext 320 nkuntawo@med.cmu.ac.th

Locations
Thailand
Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital Not yet recruiting
Chiang Mai, Thailand, 50200
Sub-Investigator: Tinakon - Wongpakaran, M.D.         
Sub-Investigator: Paritat - Silpakit, M.D.         
Sub-Investigator: Sawaeng - Saenbutra, M.Sc.         
Sub-Investigator: Manachai - Rodcheun, Ph.D.         
Sub-Investigator: Phramahabunchuay - Doojai, M.A.         
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Nahathai - Wongpakaran, M.D. Chiang Mai University
  More Information

No publications provided

Responsible Party: Nahathai Wongpakaran, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01706731     History of Changes
Other Study ID Numbers: 918
Study First Received: October 8, 2012
Last Updated: October 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Chiang Mai University:
Buddhist monks
CBT
elderly
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014