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
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
-
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.
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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.
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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.