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

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Treatment as usual
Cognitive-behavioral therapy
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Buddhist monks, CBT, elderly, depression

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TAU plus Cognitive-behavioral Therapy

TAU plus routine counselling

Arm Description

Participants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks.

Participants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks.

Outcomes

Primary Outcome Measures

Evidence of clinically depression confirmed by clinician
Depression will be assessed by HAMD-7 (McIntyre, 2005)
Depression- self report
depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)

Secondary Outcome Measures

Dimensional psychological distress (anxiety, depression,and somatization)
anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),
Dimensional psychological distress ( perception of stress)
Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)

Full Information

First Posted
October 8, 2012
Last Updated
October 12, 2012
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT01706731
Brief Title
Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Buddhist monks, CBT, elderly, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU plus Cognitive-behavioral Therapy
Arm Type
Active Comparator
Arm Description
Participants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks.
Arm Title
TAU plus routine counselling
Arm Type
Sham Comparator
Arm Description
Participants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.
Primary Outcome Measure Information:
Title
Evidence of clinically depression confirmed by clinician
Description
Depression will be assessed by HAMD-7 (McIntyre, 2005)
Time Frame
2 months after the end of the intervention
Title
Depression- self report
Description
depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh & Yesavage, 1986)
Time Frame
2 month after the end of the inetrvention
Secondary Outcome Measure Information:
Title
Dimensional psychological distress (anxiety, depression,and somatization)
Description
anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),
Time Frame
week 6, 12, 20
Title
Dimensional psychological distress ( perception of stress)
Description
Perception of stress will be assessed by Perceived Stress Scale-10 (PSS-10) (Cohen 1983 ; Wongpakaran, 2010)
Time Frame
Week 6, 12, 20
Other Pre-specified Outcome Measures:
Title
working alliance
Description
Working alliance will be assessed by the Helping Alliance Questionnaire (HAQ)(Luborsky, 1996)
Time Frame
after session 3, 6, and 12
Title
Pretreatment measure (attachment)
Description
The part includes participants' attachment which will be assessed by the revised Experience of Close Relationships Questionnaire (ECR-R 18)(Wongpakaran, 2012)
Time Frame
at baseline
Title
Pretreatment measure (interpersonal problems)
Description
Interpersonal problems will be assessed by the inventory of interpersonal problems(Horowitz, 2000)
Time Frame
at baseline
Title
Pretreatment measure(neuroticism)
Description
Neuroticism will be assessed by the Neuroticsm Inventory (Wongpakaran,unpublished)
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nahathai - Wongpakaran, M.D.
Phone
+66 53 945422
Ext
320
Email
nkuntawo@med.cmu.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahathai - Wongpakaran, M.D.
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tinakon - Wongpakaran, M.D.
First Name & Middle Initial & Last Name & Degree
Paritat - Silpakit, M.D.
First Name & Middle Initial & Last Name & Degree
Sawaeng - Saenbutra, M.Sc.
First Name & Middle Initial & Last Name & Degree
Manachai - Rodcheun, Ph.D.
First Name & Middle Initial & Last Name & Degree
Phramahabunchuay - Doojai, M.A.

12. IPD Sharing Statement

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Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy

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