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| A randomised controlled trial of the feasibility and effectiveness of Internet-based interventions for depression in a telephone counselling setting |
| ISRCTN | ISRCTN93903959 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised controlled trial of the feasibility and effectiveness of Internet-based interventions for depression in a telephone counselling setting |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Countries of recruitment | Australia |
| Disease/condition/study domain | Depression and anxiety |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 400 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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) |
| Sources of funding | Australian Research Council, Linkage Grant (ref: LP0667970) |
| Trial website | |
| Publications | |
| Contact name | Prof Helen Christensen |
| Address |
Centre for Mental Health Research
Building 63 Eggleston Road The Australian National University |
| City/town | Canberra, ACT |
| Zip/Postcode | 0200 |
| Country | Australia |
| helen.christensen@anu.edu.au | |
| Sponsor | The Australian National University (Australia) |
| Address |
Centre for Mental Health Research
Building 63 Eggleston Road |
| City/town | Canberra, ACT |
| Zip/Postcode | 0200 |
| Country | Australia |
| Sponsor website: | http://www.anu.edu.au |
| Date applied | 10/04/2008 |
| Last edited | 23/04/2008 |
| Date ISRCTN assigned | 22/04/2008 |
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