Trial from ANZCTR


Trial ID ACTRN12609000559213
Trial Status: Registered
Date Submitted: 3/07/2009
Date Registered: 9/07/2009
Prospectively registered

Page 1

Public title Internet-based treatment of depression (the Sadness program): A randomized controlled study exploring the role of a clinician.
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomized controlled trial comparing clinician-assisted Internet based treatment for depression vs. weekly telephone reminders vs. a waitlist control condition on severity of symptoms of depression.
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym Sadness RCT2
Update:
 

Page 2

Health condition(s) or problem(s) studied:
Depression 237157 0
 Update:
 Reason:
Condition category: Condition code:
Mental Health Depression
 Update:
 Update:
  Reason:
237483 237483 0 0

Page 3

Descriptions of intervention(s) / exposure Participants will be randomly assigned to one of three groups: 1) Treatment with clinician-assisted Internet based treatment for depression, or; 2) Treatment with self-guided Internet based treatment for depression + weekly reminder telephone calls from a technician, or; 3) Waitlist control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for depression. All group 1 and group 2 participants will complete 6 lessons of Internet based treatment about the management of symptoms of depression. One lesson will be completed every 7 to 14 days. Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, will contribute to an online forum moderated by a clinical psychologist or psychiatrist, and will receive weekly reminder emails. Group 2 participants will have access to summaries of each lesson, will receive weekly telephone reminders from a technician, and will receive weekly reminder emails. The duration of the program is 8 weeks, but participants will be contacted 2 and 4 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-treatment, post-treatment, and at 2 and 4-months post-treatment. These will take about 20 minutes to complete. The treatment materials are based on cognitive behavioural techniques.
Update:
 
Reason:
 
Intervention Code:
Treatment: Other 236871 0
Update:
 
Reason:
 
Comparator / control treatment Waitlist control group. These participants remain on the waitlist until the treatment groups have completed their treatment (8 weeks). At that time (8 weeks) the waitlist group will receive the same treatment as Treatment Group 1.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9). 238289 0
Update:
 
Reason:
 
Timepoint: Administered at application, pre-treatment, post-treatment, and at 2 and 4-months post-treatment. 238289 0
Update:
 
Reason:
 
Primary Outcome: Symptoms and severity of depression is measured by the Beck Depression Inventory - II (BDI-II). 238290 0
Update:
 
Reason:
 
Timepoint: Administered at pre-treatment, post-treatment, and at 2 and 4-months post-treatment. 238290 0
Update:
 
Reason:
 
Secondary Outcome: Psychological distress is measured by the Kessler-10 (K-10). 244663 0
Update:
 
Reason:
 
Timepoint: Administered at pre-treatment, post-treatment, and at 2 and 4-months post-treatment. 244663 0
Update:
 
Reason:
 
Secondary Outcome: Disability is measured by the Sheehan Disability Scale. 244664 0
Update:
 
Reason:
 
Timepoint: Administered at pre-treatment, post-treatment, and at 2 and 4-months post-treatment. 244664 0
Update:
 
Reason:
 
Secondary Outcome: Anxiety is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire. 244665 0
Update:
 
Reason:
 
Timepoint: Administered at application, pre-treatment, post-treatment, and at 2 and 4-months post-treatment. 244665 0
Update:
 
Reason:
 

Page 5

Key inclusion criteria Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for depression - Internet access + printer access. - Australian citizen- Males and females
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
Key exclusion criteria Current substance abuse/dependence- Psychotic disorder- Current or planned psychological treatment during study duration- Change in medications during last 1 month or intended change during study duration
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Treatment
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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 the Mini-International Neuropsychiatric
Interview (MINI 5.0.0), a structured diagnostic interview. Participants will be randomized using a list generated prior to the study. Allocation concealment will occur by contacting the holder of the allocation schedule who is off-site.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Open (masking not used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 3/09/2009
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 120
Update:
 
Reason:
 
Actual sample size
Update:
 
Reason:
 
Recruitment status Closed: follow-up continuing
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: University 237260 0
Update:
 
Reason:
 
Name: School of Psychiatry, University of New South Wales at St Vincent's Hospital 237260 0
Update:
 
Reason:
 
Address: 299 Forbes Street Darlinghurst NSW2010 237260 0
Update:
 
Reason:
 
Country: Australia 237260 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: School of Psychiatry, University of New South Wales at St Vincent's Hospital
Update:
 
Reason:
 
Address: 299 Forbes Street Darlinghurst NSW2010
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 236746 0
Update:
 
Reason:
 
Name: 236746 0
Update:
 
Reason:
 
Address: 236746 0
Update:
 
Reason:
 
Country: 236746 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: St Vincent's Hospital Human Research Ethics Committee (HREC) 239362 0
Update:
 
Reason:
 
Address: St Vincent's Hospital HREC
390 Victoria Street
Darlinghurst NSW 2010
239362 0
Update:
 
Reason:
 
Country: Australia 239362 0
Update:
 
Reason:
 
Approval Date: 29/04/2008 239362 0
Update:
 
Reason:
 
Submitted Date: 239362 0
Update:
 
Reason:
 
HREC: HREC08/SVH/36 239362 0
Update:
 
Reason:
 
Brief summary Our previous research indicates that the Sadness Program, an Internet-based treatment program for people with depression, is effective at helping people to learn to manage their symptoms of depression.

The study described here aims to find out whether therapist support is required for people to successfully complete the Sadness Program.

We expect that people completing the Sadness Program without therapist support (but who receive weekly telephone reminders) will still benefit, but not as much as those receiving the usual levels of therapist support.
Update:
 
Reason:
 
Trial website www.virtualclinic.org.au
Update:
 
Trial related presentations / publications Perini S, Titov N, Andrews G. Clinician-assisted Internet-based treatment is effective for depression: A randomized controlled trial. In press. Aust N Z J Psychiatry.


Perini S, Titov N, Andrews G. The Climate Sadness program: an open trial of Internet-based treatment for depression. E-Journal of Applied Psychology [Online]. 2008 Dec 23 [cited 21/01/2008]; 4:2. Available: http://ojs.lib.swin.edu.au/index.php/ejap/article/view/135/140
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
29846 0
Name:
Update:
 
Reason:
 
29846 0
Address:
Update:
 
Reason:
 
29846 0
Country:
Update:
 
29846 0
Reason:
 
Tel:
Update:
 
Reason:
 
29846 0
Fax:
Update:
 
Reason:
 
29846 0
Email:
Update:
 
Reason:
 
29846 0
Contact person for public queries
Title:
Update:
 
Reason:
 
13093 0
Name: Professor Gavin Andrews
Update:
 
Reason:
 
13093 0
Address: 299 Forbes Street Darlinghurst NSW2010
Update:
 
Reason:
 
13093 0
Country: Australia
Update:
 
13093 0
Reason:
 
Tel: 612 8382 1726
Update:
 
Reason:
 
13093 0
Fax: 612 8382 1721
Update:
 
Reason:
 
13093 0
Email: gavina@unsw.edu.au
Update:
 
Reason:
 
13093 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
4021 0
Name: Professor Gavin Andrews
Update:
 
Reason:
 
4021 0
Address: 299 Forbes Street Darlinghurst NSW2010
Update:
 
Reason:
 
4021 0
Country: Australia
Update:
 
4021 0
Reason:
 
Tel: 612 8382 1726
Update:
 
Reason:
 
4021 0
Fax: 612 8382 1721
Update:
 
Reason:
 
4021 0
Email: gavina@unsw.edu.au
Update:
 
Reason:
 
4021 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
22165 0
Name: Dr Nickolai Titov
Update:
 
Reason:
 
22165 0
Address: 299 Forbes Street Darlinghurst NSW2010
Update:
 
Reason:
 
22165 0
Country: Australia
Update:
 
22165 0
Reason:
 
Tel: 612 8382 1726
Update:
 
Reason:
 
22165 0
Fax: 612 8382 1721
Update:
 
Reason:
 
22165 0
Email: nickt@unsw.edu.au
Update:
 
Reason:
 
22165 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: