Condition category
Mental and Behavioural Disorders
Date applied
10/04/2008
Date assigned
22/04/2008
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Helen Christensen

ORCID ID

Contact details

Centre for Mental Health Research
Building 63
Eggleston Road
The Australian National University
Canberra
ACT
0200
Australia
helen.christensen@anu.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of this research is to evaluate the effectiveness of Internet-based tools (MoodGYM [http://www.moodgym.anu.edu.au] and BluePages [http://www.bluepages.anu.edu.au]) in the treatment of depression and anxiety among callers to a large, national telephone counselling centre. This project will use a randomised controlled trial to assess 1) whether self-administered online cognitive behaviour therapy and psychoeducation are effective in reducing symptoms of depression and anxiety and 2) whether regular contact from a telephone counsellor optimises the effectiveness of these programs.

Ethics approval

Australian National University Human Ethics Committee. Date of approval: 14/03/2007 (ref: 2007/12)

Study design

Stratified, multi-centre, randomised controlled trial. 2 x 2 factorial design.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression and anxiety

Intervention

The participants will be randomly allocated to the following four arms:

Arm 1: MoodGYM, an evidence based depression prevention website based on cognitive behavioural therapy, and BluePages, a website providing evidenced based information on depression.

Arm 2: MoodGYM and BluePages plus weekly telephone contact from a support person.

Arm 3: Attention control condition, in which participants receive weekly telephone contact from a support person to discuss factors associated with depression.

Arm 4: "Treatment as usual" control condition, in which participants access telephone counselling as usual.

Duration of interventions: 6 weeks

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be assessed at pre-intervention, post-intervention, and 6 and 12 months post-intervention:
1. Depression, as measured by the Centre for Epidemiological Studies Depression Scale
2. Anxiety, as measured by the Depression Anxiety and Stress Scales

Secondary outcome measures

The following will be assessed at pre-intervention, post-intervention, and 6 and 12 months post-intervention:
1. Dysfunctional thoughts (Automatic Thoughts Questionnaire)
2. Personal stigma, assessed by a scale developed by the researchers of this study
3. Beliefs about the Internet, assessed by the items developed by the researchers of this study
4. Mental health literacy, assessed by the items developed by the researchers of this study
5. Help-seeking, assessed by the items developed by the researchers of this study
6. Depression literacy, assessed by the items developed by the researchers of this study
7. Cognitive behaviour therapy literacy, assessed by the items developed by the researchers of this study
8. Alcohol use, measured by the Alcohol Use Disorders Identification Test
9. Quality of life, assessed by the European Health Interview Survey 8 (EUROHIS-8)
10. Suicidal ideation, assessed using four items from the 28-item General Health Questionnaire (GHQ-28)

Overall trial start date

01/07/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Callers to a national telephone counselling service who:
1. Are aged 18 years or older, both men and women
2. Consent to participate
3. Are English-speaking
4. Have access to the Internet at least once a week
5. Obtain a score of 22 or above on the Kessler Psychological Distress Scale (K-10)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Individuals who:
1. Report a history of schizophrenia, psychosis or bipolar disorder
2. Are currently receiving cognitive behavioural therapy
3. Have a reading impairment

Recruitment start date

01/07/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Mental Health Research
Canberra, ACT
0200
Australia

Sponsor information

Organisation

The Australian National University (Australia)

Sponsor details

Centre for Mental Health Research
Building 63
Eggleston Road
Canberra
ACT
0200
Australia

Sponsor type

University/education

Website

http://www.anu.edu.au

Funders

Funder type

Government

Funder name

Australian Research Council, Linkage Grant (ref: LP0667970)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 evaluation of recruitment challenges in http://www.ncbi.nlm.nih.gov/pubmed/20643848
2. 2011 effectiveness of internet-based interventions in http://www.ncbi.nlm.nih.gov/pubmed/22140514
3. 2012 secondary outcomes results in http://www.ncbi.nlm.nih.gov/pubmed/22738715

Publication citations

  1. Evaluation of recruitment challenges

    Burgess N, Christensen H, Griffiths KM, Farrer L, Recruitment challenges associated with a randomised controlled trial within a general telephone counselling service., J Telemed Telecare, 2010, 16, 7, 409-413, doi: 10.1258/jtt.2010.090814.

  2. Secondary outcomes results

    Farrer L, Christensen H, Griffiths KM, Mackinnon A, Web-based cognitive behavior therapy for depression with and without telephone tracking in a national helpline: secondary outcomes from a randomized controlled trial., J. Med. Internet Res., 2012, 14, 3, e68, doi: 10.2196/jmir.1859.

  3. Farrer L, Christensen H, Griffiths KM, Mackinnon A, Internet-based CBT for depression with and without telephone tracking in a national helpline: randomised controlled trial., PLoS ONE, 2011, 6, 11, e28099, doi: 10.1371/journal.pone.0028099.

Additional files

Editorial Notes