Major Depressive DisorderAdd-CBTNCT01706731
Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy
A study testing Treatment as usual and Cognitive-behavioral therapy in people with Major Depressive Disorder, run by Chiang Mai University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Treatment as usual and Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet criteria for Major depressive disorder
- receiving antidepressant
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Chiang Mai, 50200
Tinakon - Wongpakaran, M.D.
Paritat - Silpakit, M.D.
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Treatment as usual, Cognitive-behavioral therapy
- Keywords
- Buddhist monks, CBT, elderly, depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
Also called TAU
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 therapyBehavioural
Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Treatment as usual; Behavioral: 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically depression confirmed by clinician
Depression will be assessed by HAMD-7 (McIntyre, 2005)
Measured: 2 months after the end of the intervention
Depression- self report
depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh \& Yesavage, 1986)
Measured: 2 month after the end of the inetrvention
Secondary outcomes (2)
Dimensional psychological distress (anxiety, depression,and somatization)
anxiety, depression,and somatization symptom will be assessed by the Core symptom index (CSI) (Wongpakaran, unpublished),
Measured: 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)
Measured: Week 6, 12, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahathai Wongpakaran, Chiang Mai University
- Investigators
- Nahathai - Wongpakaran, M.D., Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706731
- Sponsor's protocol ID
- 918
- Acronym
- Add-CBT
- Status last verified
- Oct 2012
- First submitted
- 8 Oct 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01706731
- Acronym / sponsor ID
- Add-CBT / 918
- Conditions
- Major Depressive Disorder
- Keywords
- Buddhist monks, CBT, elderly, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU plus Cognitive-behavioral Therapy | Active comparator | Behavioral: Treatment as usual, Behavioral: Cognitive-behavioral therapyParticipants randomized to this group will receive treatment as usual plus cognitive behavioral therapy (CBT) provided by trained Buddhist monks. |
| TAU plus routine counselling | Sham comparator | Behavioral: Treatment as usualParticipants randomized into this group will receive treatment as usual (TAU) plus plus routine psychological support from non-CBT monks. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet criteria for Major depressive disorder
- receiving antidepressant
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualAlso: TAUTreatment 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. | Behavioural | TAU plus Cognitive-behavioral Therapy, TAU plus routine counselling |
| Cognitive-behavioral therapyCognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts. | Behavioural | TAU plus Cognitive-behavioral Therapy |
Primary outcome
Evidence of clinically depression confirmed by clinician
Time frame: 2 months after the end of the intervention
Depression will be assessed by HAMD-7 (McIntyre, 2005)
Depression- self report
Time frame: 2 month after the end of the inetrvention
depression will be assessed by Geriatric Depression Scale (GDS)(Shiekh \& Yesavage, 1986)
2 secondary outcomes
Dimensional psychological distress (anxiety, depression,and somatization)
Time frame: week 6, 12, 20
Dimensional psychological distress ( perception of stress)
Time frame: Week 6, 12, 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahathai - Wongpakaran, M.D. principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual and Cognitive-behavioral therapy in people with Major Depressive Disorder, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahathai - Wongpakaran, M.D. (+66 53 945422 ext. 320, nkuntawo@med.cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically depression confirmed by clinician (time frame: 2 months after the end of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.