ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000559213

Ethics application status

Approved

Date submitted

3/07/2009

Date registered

9/07/2009

Date last updated

3/12/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Internet-based treatment of depression (the Sadness program): A randomized controlled study exploring the role of a clinician.

Scientific title

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.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Sadness RCT2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description 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.

Intervention code [1]

Treatment: Other

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.

Control group

Active

Outcomes

Primary outcome [1]

Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).

Timepoint [1]

Administered at application, pre-treatment, post-treatment, and at 2 and 4-months post-treatment.

Primary outcome [2]

Symptoms and severity of depression is measured by the Beck Depression Inventory - II (BDI-II).

Timepoint [2]

Administered at pre-treatment, post-treatment, and at 2 and 4-months post-treatment.

Secondary outcome [1]

Psychological distress is measured by the Kessler-10 (K-10).

Timepoint [1]

Administered at pre-treatment, post-treatment, and at 2 and 4-months post-treatment.

Secondary outcome [2]

Disability is measured by the Sheehan Disability Scale.

Timepoint [2]

Administered at pre-treatment, post-treatment, and at 2 and 4-months post-treatment.

Secondary outcome [3]

Anxiety is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.

Timepoint [3]

Administered at application, pre-treatment, post-treatment, and at 2 and 4-months post-treatment.

Eligibility

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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

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)

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.

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

Open (masking not 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

Completed

Date of first participant enrolment

Anticipated

3/09/2009

Actual

3/09/2009

Date of last participant enrolment

Anticipated

1/12/2009

Actual

1/12/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

141

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Psychiatry, University of New South Wales at St Vincent's Hospital

Address [1]

299 Forbes Street Darlinghurst NSW2010

Country [1]

Australia

Primary sponsor type

University

Name

School of Psychiatry, University of New South Wales at St Vincent's Hospital

Address

299 Forbes Street Darlinghurst NSW2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Human Research Ethics Committee (HREC)

Ethics committee address [1]

St Vincent's Hospital HREC 
390 Victoria Street
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/04/2008

Ethics approval number [1]

HREC08/SVH/36

Summary

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.

Trial website

www.virtualclinic.org.au

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

Titov, N., Andrews, G., Davies, M., McIntyre, K., Robinson, E., & Solley, K. (2010). Internet treatment for depression: A randomized controlled trial comparing clinician vs. technician assistance. PLoS ONE, 5, e10939.

Public notes

Contacts

Principal investigator

Name

Prof Nick Titov

Address

Department of Psychology
Macquarie University
NSW 2109

Country

Australia

Phone

61 2 9850 9901

Fax

nick.titov@mq.edu.au

Contact person for public queries

Name

Professor Gavin Andrews

Address

299 Forbes Street
Darlinghurst
NSW2010

Country

Australia

Phone

612 8382 1726

Fax

612 8382 1721

gavina@unsw.edu.au

Contact person for scientific queries

Name

Professor Gavin Andrews

Address

299 Forbes Street
Darlinghurst
NSW2010

Country

Australia

Phone

612 8382 1726

Fax

612 8382 1721

gavina@unsw.edu.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Internet Treatment for Depression: A Randomized Controlled Trial Comparing Clinician vs. Technician Assistance	2010	https://doi.org/10.1371/journal.pone.0010939

N.B. These documents automatically identified may not have been verified by the study sponsor.

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