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
ACTRN12609000009213
Ethics application status
Approved
Date submitted
12/09/2008
Date registered
7/01/2009
Date last updated
7/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet based education for depression: An initial randomized controlled study
Scientific title
A randomized controlled study on the effect of Internet based education for treating depression using cognitive behavioural techniques.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 3669 0
Condition category
Condition code
Mental Health 3836 3836 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized trial of 6 lessons of Internet based education for people who meet the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for major depressive disorder. One lesson will be completed every 7 to 10 days (each lesson will involve homework, an online discussion forum assignment, email contact with clinicians, and an online reading assignment, requiring up to 4 hours/week) vs wait-list control. The lessons will be completed by participants online in their own homes. Study questionnaires will be administered at application, beginning of the first lesson, 1-week poststudy, and 6 months follow-up. The educational materials are based on cognitive behavioural techniques. Once Education Group participants have completed the 6 lessons the Wait-List group participants will begin the lessons.
Intervention code [1] 3384 0
Treatment: Other
Comparator / control treatment
Waitlist control
Control group
Active

Outcomes
Primary outcome [1] 4732 0
Depression measured using the Beck Depression Inventory II
Timepoint [1] 4732 0
Administered at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [2] 4733 0
Depression measured using the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 4733 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Primary outcome [3] 4734 0
Psychological distress measured using the Kessler-10 (K-10)
Timepoint [3] 4734 0
Administered at application, at the beginning of the first lesson, 1-week poststudy, and at 6 months follow-up
Secondary outcome [1] 7991 0
Change between the primary outcome measure scores at pre and post treatment. The primary outcome measures are the Beck Depression Inventory II (BDI-II), Patient Health Questionnaire (PHQ-9), and Kessler-10 (K-10).
Timepoint [1] 7991 0
Measured at the time of application and at the beginning of the first lesson.

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for major depressive disorder - Internet access + printer access. - Australian citizen- Males and females-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance abuse/dependence- Psychotic disorder-PHQ 9 score of lower than 5 or higher than 23- moderate or high suicide risk

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply on line, followed by a telephone interview to confirm diagnosis via structured diagnostic interview (MINI). Participants will be randomized using a list generated prior to the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list will be generated prior to the study using computer software.
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
Recruiting
Date of first participant enrolment
Anticipated
13/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3859 0
Hospital
Name [1] 3859 0
St Vincents Hospital, Anxiety Disorders Clinic
Country [1] 3859 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital, Anxiety Disorders Clinic
Address
299 Forbes Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 3465 0
None
Name [1] 3465 0
Address [1] 3465 0
Country [1] 3465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5913 0
St Vincents's Hospital
Ethics committee address [1] 5913 0
Level 6, de Lacy Building
St Vincent's Hospital
390 Victoria Street,
Darlinghurst NSW 2010
Ethics committee country [1] 5913 0
Australia
Date submitted for ethics approval [1] 5913 0
Approval date [1] 5913 0
08/04/2008
Ethics approval number [1] 5913 0
08/SVH/36

Summary
Brief summary
We will examine the efficacy of an Internet based education program for improving the mental health of people with depression. Participants will be recruited via a website developed for this Program (www.climateclinic.tv), and a structured diagnostic interview via telephone. Consenting participants will be randomly allocated to an active Education Group, or Wait-List Control Group. Participants will complete six lessons of Cognitive Behaviour Therapy (CBT) based education delivered via the Internet and weekly emails from a clinician, weekly homework, and weekly contact with other participants via an online discussion board. Participants will be assessed at application, prestudy, one week poststudy, and 6 months poststudy. Once the Education Group have completed the lessons the Control Group will be given access to the lessons.
Trial website
www.climateclinic.tv
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28918 0
Address 28918 0
Country 28918 0
Phone 28918 0
Fax 28918 0
Email 28918 0
Contact person for public queries
Name 12075 0
Professor Gavin Andrews
Address 12075 0
299 Forbes Street
Darlinghurst NSW 2010
Country 12075 0
Australia
Phone 12075 0
02 8382 1726
Fax 12075 0
Email 12075 0
[email protected]
Contact person for scientific queries
Name 3003 0
Professor Gavin Andrews
Address 3003 0
299 Forbes Street
Darlinghurst NSW 2010
Country 3003 0
Australia
Phone 3003 0
02 8382 1726
Fax 3003 0
Email 3003 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.