Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000402549
Ethics application status
Approved
Date submitted
8/09/2006
Date registered
13/09/2006
Date last updated
1/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) for depression
Scientific title
Predictors of improvement and mechanisms of change in group Cognitive Behaviour Therapy (CBT) and Mindfulness Based Cognitive Therapy (MBCT) for depression: a two stage study
Secondary ID [1] 253150 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 1368 0
Condition category
Condition code
Mental Health 1461 1461 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are experiencing depression will be randomly allocated to either the Cognitive Behavioural Therapy or Mindfulness-Based Cognitive Therapy. Both groups will run for 8 weeks for 2.5 hours per session. Both groups will be faciliated by trained and registered psychologists.
Intervention code [1] 1349 0
Treatment: Other
Comparator / control treatment
Cognitive Behavioural Therapy vs Mindfulness-Based Cognitive Therapy
Control group
Active

Outcomes
Primary outcome [1] 2014 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- NEO-Five Factor Inventory
Timepoint [1] 2014 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [2] 2015 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Temperament and Personality Questionnaire
Timepoint [2] 2015 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [3] 2016 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Young Cognitive Schema Questionnaire
Timepoint [3] 2016 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [4] 2017 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Beck Depression Inventory - II
Timepoint [4] 2017 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [5] 2018 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Brief Measure of Worry Questionnaire
Timepoint [5] 2018 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [6] 2019 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Composite International Diagnostic Interview for Major Depressive Disorder (pre-group measure only)
Timepoint [6] 2019 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [7] 2020 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Hamilton Depression Scale (HAMD)
Timepoint [7] 2020 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [8] 2021 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [8] 2021 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Primary outcome [9] 2022 0
To assess the effectiveness of Mindfulness-Based Cognitive Therapy and Cognitive Behavioural Therapy in alleviating symptoms of depression following an 8-week group program, a series of questionnaires and acitivities will be administered including:
- Daily Mood Chart
Timepoint [9] 2022 0
Prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention.
Secondary outcome [1] 3489 0
That improvement in depression symptoms in the Mindfulness-Based Cognitive Therapy group are mediated by change in attentional control in contrast to the Cognitive Behavioural Therapy group where improvement in depression symptoms is mediated by cognitive change
That participants in the Mindfulness-Based Cognitive Therapy group will demonstrate greater improvements at 8 weeks and at follow ups in measure of anxiety and mindfulness than participants in the Cognitive Behavioural Therapy group. Conversely, Cognitive Behavioural Therapy group members will demonstrate greater improvements in changing negative thinking styles than those in the Mindfulness-Based Cognitive Therapy group at 8-week and at follow-ups
Subjects who maintain their skills in both groups over the follow-up periods of 6- and 12-months will continue to improve or maintain improvements when compared to those who do not.
Timepoint [1] 3489 0
This will be measured through questionnaires and activities administered prior to the groups commencing to establish baseline, during the sessions to assess progress, at the completion of the group and then at 6-month and 12-month followup to establish the longer term effects of the intervention. The questionnaires included are
- Composite International Diagnostic Interview for and Anxiety (pre-group measure only)
- Beck Anxiety Index
- Rational-Experiential Inventory
- Anxiety Sensitivity Index
- Mindful Attention Awareness Scale

Eligibility
Key inclusion criteria
Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for Major Depressive Disorder /Dysthymis (Composite International Diagnostic Interview assessment)Score 19 or more for Beck Depression Inventory and 12 or more for HAMDMust have been depressed for at least 3 months (no upper limit)Proficiency in EnglishNo prior history of Cognitive Behavioural Therpay or formal training in Mindfulness or meditation/relaxation (operationalised as more than 4 sessions or regular meditation/relaxation) and not currently receiving psychological therapyMust have a case manager/clinicianNot currently on antidepressants, or have not changed their medication regimen over the last three months but remain significantly depressedCommitment to an 8 week program
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Melancholic Depression (currently)History of any psychotic illnessDementiaCurrent suicidal ideationInpatient statusConcurrent treatment using meditation or Cognitive Behavioural TherapyDrug/alcohol dependenceDaytime anxiolytic medication (sedatives at night OK)Bipolar DisorderAntenatal or postnatal depressionAntipsychotics or mood stabilisersHave been treated with more than 2 antidepressants previously.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Two staff members not involved with the design/administration of therapy will be assigned the role of randomisers, to randomly allocate participants to either the Cognitive Behavioural Therapy or Mindfulness-Based Cognitive Therapy groups. Central randomisation will be done by computer and data analyst will not have access to this database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisers will set up an excel spreadsheet of participant numbers and select the randomise option to assign a value of 0 (for CBT) or 1 (MBCT) to each participant number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The data analyst will be blind to which groups the subjects are in.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1599 0
Government body
Name [1] 1599 0
National Health and Medical Research Council Program Grant
Country [1] 1599 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 1404 0
None
Name [1] 1404 0
Nil
Address [1] 1404 0
Country [1] 1404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3048 0
University of New South Wales
Ethics committee address [1] 3048 0
Ethics committee country [1] 3048 0
Australia
Date submitted for ethics approval [1] 3048 0
Approval date [1] 3048 0
02/08/2006
Ethics approval number [1] 3048 0
05269

Summary
Brief summary
This study aims to examine the effectiveness of group Mindfulness-Based Cognitive Therapy (MBCT) and standard Cognitive Behavioural Therapy (CBT) as treatments for depression as well as examine the mechanisms of change and predictors of change in both groups. Depressed participants will be recruited and randomly assigned to receive one of the group programs. Both programs will run for 2.5 hours a week for eight weeks. Participants will receive a clinical assessment prior to randomisation and will complete a number of questionnaires before and after the group program and at follow-up assessments at 6 and 12 months. The first pilot phase of the study will assess feasibility and likely effectiveness of MBCT, and pending results will be followed by the second main phase of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27956 0
Address 27956 0
Country 27956 0
Phone 27956 0
Fax 27956 0
Email 27956 0
Contact person for public queries
Name 10538 0
A/Prof Vijaya Manicavasagar - STUDY COMPLETED
Address 10538 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 10538 0
Australia
Phone 10538 0
02 9382 4320
Fax 10538 0
02 9382 4343
Email 10538 0
[email protected]
Contact person for scientific queries
Name 1466 0
Professor Gordon Parker
Address 1466 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 1466 0
Australia
Phone 1466 0
02 9382 4372
Fax 1466 0
02 9382 4343
Email 1466 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.