NCT01706731

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 8, 2012

Last Update Submit

October 12, 2012

Conditions

Major Depressive Disorder

Keywords

Buddhist monksCBTelderlydepression

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Dimensional psychological distress (anxiety, depression,and somatization)

    week 6, 12, 20

  • Dimensional psychological distress ( perception of stress)

    Week 6, 12, 20

Other Outcomes (4)

  • working alliance

    after session 3, 6, and 12

  • Pretreatment measure (attachment)

    at baseline

  • Pretreatment measure (interpersonal problems)

    at baseline

  • +1 more other outcomes

Study Arms (2)

TAU plus Cognitive-behavioral Therapy

ACTIVE COMPARATOR

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

Behavioral: Treatment as usualBehavioral: Cognitive-behavioral therapy

TAU plus routine counselling

SHAM COMPARATOR

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

Behavioral: Treatment as usual

Interventions

Treatment as usualBEHAVIORAL

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.

Also known as: TAU
TAU plus Cognitive-behavioral TherapyTAU plus routine counselling
Cognitive-behavioral therapyBEHAVIORAL

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

TAU plus Cognitive-behavioral Therapy

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet criteria for Major depressive disorder
  • receiving antidepressant

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

TherapeuticsCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nahathai - Wongpakaran, M.D.

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahathai - Wongpakaran, M.D.

CONTACT

+66 53 945422nkuntawo@med.cmu.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 15, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

TH(1)