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

A Randomized Controlled Trial of Cognitive Behavior Therapy Provided by Buddhist Monks vs. Treatment as Usual in the Treatment of Late Life-depression

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Treatment as usual; Behavioral: Cognitive-behavioral therapy

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of clinically depression confirmed by clinician	Depression will be assessed by HAMD-7 (McIntyre, 2005)	2 months after the end of the intervention
Depression- self report	depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)	2 month after the end of the inetrvention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
working alliance	Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)	after session 3, 6, and 12
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
Pretreatment measure (interpersonal problems)	Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)	at baseline
Pretreatment measure(neuroticism)	Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)	at baseline

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Nahathai - Wongpakaran, M.D., Chiang Mai University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2013
• Study Completion (ANTICIPATED): October 1, 2013

Study Registration Dates

• First Submitted: October 8, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (ESTIMATE): October 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: depression; elderly; CBT; Buddhist monks
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 918