Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Treatment as usual
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAU plus Cognitive-behavioral Therapy<br>Participants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks. | Behavioral: Treatment as usual<br>* 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.<br>* Other names: TAU;Behavioral: Cognitive-behavioral therapy<br>* Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.<br>|
| Sham Comparator: TAU plus routine counselling<br>Participants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks. | Behavioral: Treatment as usual<br>* 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.<br>* Other names: TAU;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buddhist monks, elderly, depression, CBT