Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy

Major Depressive Disorder Clinical Trial

— Add-CBT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01706731
• Other study ID #: 918
• Status: Not yet recruiting
• Phase: N/A
• First received: October 8, 2012
• Last updated: October 12, 2012
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2012
• Source: Chiang Mai University
• Contact: Nahathai - Wongpakaran, M.D.
• Phone: +66 53 945422
• Email: nkuntawo[@]med.cmu.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 95 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• Cognitive-behavioral therapy
Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.

Locations

Country	Name	City	State
Thailand	Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	working alliance	Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)	after session 3, 6, and 12	No
Other	Pretreatment measure (attachment)	The part includes participants' attachment which will be assessed by the revised Experience of Close Relationships Questionnaire (ECR-R 18)(Wongpakaran, 2012)	at baseline	No
Other	Pretreatment measure (interpersonal problems)	Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)	at baseline	No
Other	Pretreatment measure(neuroticism)	Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)	at baseline	No
Primary	Evidence of clinically depression confirmed by clinician	Depression will be assessed by HAMD-7 (McIntyre, 2005)	2 months after the end of the intervention	No
Primary	Depression- self report	depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)	2 month after the end of the inetrvention	No
Secondary	Dimensional psychological distress (anxiety, depression,and somatization)	anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),	week 6, 12, 20	No
Secondary	Dimensional psychological distress ( perception of stress)	Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)	Week 6, 12, 20	No