Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000614897
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
8/06/2012
Date last updated
8/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of MoodGroup, an online group therapy intervention for the treatment of depression in Australian adults.
Scientific title
Will MoodGroup, an online group intervention, reduce depression in Australian adults?
Secondary ID [1] 280619 0
Nil
Universal Trial Number (UTN)
U1111-1131-4839
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 286631 0
Condition category
Condition code
Mental Health 286914 286914 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MoodGroup is an online group intervention designed for to reduce depressive symptoms in Australian adults. It uses cognitive behavioural therapy. The intervention comprises 6-8 particpants and runs for 2 hours per week for 9 weeks. It is facilitated by provisional psychologists. The MoodGroup intervention is conducted in an online classroom hosted by Blackboard Collaborate. This secure classroom allows particpants to chat synchronously, view slide show presentations, participate in activities via a whiteboard feature and participate in small group activities. Participants will receive preparatory reading material related to each week's session and will be required to be familiar with this material prior to each group. The online sessions will focus on activities and discussions designed to clarify and expand on the reading material. Participants will also be required to complete home activities to consolidate their learning.
Intervention code [1] 285017 0
Treatment: Other
Intervention code [2] 285018 0
Behaviour
Intervention code [3] 285019 0
Lifestyle
Comparator / control treatment
Wait-list control. The wait-list participants will be eligible to receive the intervention 9 weeks after their allocation to the wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 287269 0
% with Major Depression Inventory score >26
Timepoint [1] 287269 0
Baseline, and at 1 month, 3 months and 6 months after intervention commencement
Primary outcome [2] 287270 0
Significant increases in the Quality of Life Inventory scores.
Timepoint [2] 287270 0
Baseline, and at 1 month, 3 months and 6 months after intervention commencement
Primary outcome [3] 287271 0
Significant increasesd in the Group Climate Questionnaire scores
Timepoint [3] 287271 0
Baseline and at the conclusion of the intervention.
Secondary outcome [1] 297799 0
Significant reductions in the Depression, Anxiety and Stress Scale score
Timepoint [1] 297799 0
Baseline, and at 1 month, 3 months and 6 months after intervention commencement
Secondary outcome [2] 297800 0
Significant reductions in Dysfunctional Attitude Scale scores
Timepoint [2] 297800 0
Baseline, and at 1 month, 3 months and 6 months after intervention commencement
Secondary outcome [3] 297801 0
Significant increases in the Behavioral Activation for Depression Scale scores
Timepoint [3] 297801 0
Baseline, and at 1 month, 3 months and 6 months after intervention commencement

Eligibility
Key inclusion criteria
Major Depression Inventory score of 26 or above
Currently residing in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Modified Scale for Suicide Intervention score above 9

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5389 0
3000
Recruitment postcode(s) [2] 5390 0
2000
Recruitment postcode(s) [3] 5391 0
4000
Recruitment postcode(s) [4] 5392 0
7000
Recruitment postcode(s) [5] 5393 0
6000
Recruitment postcode(s) [6] 5394 0
0800
Recruitment postcode(s) [7] 5395 0
5000

Funding & Sponsors
Funding source category [1] 285380 0
University
Name [1] 285380 0
RMIT University
Country [1] 285380 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road
Bundoora
VIC
3083
Country
Australia
Secondary sponsor category [1] 284238 0
None
Name [1] 284238 0
Address [1] 284238 0
Country [1] 284238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287399 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 287399 0
Ethics committee country [1] 287399 0
Australia
Date submitted for ethics approval [1] 287399 0
01/07/2011
Approval date [1] 287399 0
18/07/2011
Ethics approval number [1] 287399 0
HREC33/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34267 0
Address 34267 0
Country 34267 0
Phone 34267 0
Fax 34267 0
Email 34267 0
Contact person for public queries
Name 17514 0
Kerry Arrow
Address 17514 0
RMIT University
School of Health Sciences
Division of Psychology
Level 3, Building 201
Plenty Road
Bundoora
VIC
3083
Country 17514 0
Australia
Phone 17514 0
+61452466448
Fax 17514 0
Email 17514 0
[email protected]
Contact person for scientific queries
Name 8442 0
Kerry Arrow
Address 8442 0
RMIT University
School of Health Sciences
Division of Psychology
Level 3, Building 201
Plenty Road
Bundoora
VIC
3083
Country 8442 0
Australia
Phone 8442 0
+61452466448
Fax 8442 0
Email 8442 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.