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13 May 2008
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| [ Print-friendly version ] |
| The wellbeing project: internet interventions to improve mental health and wellbeing |
| ISRCTN | ISRCTN65657330 |
| ClinicalTrials.gov identifier | |
| Public title | The wellbeing project: internet interventions to improve mental health and wellbeing |
| Scientific title | Do internet support groups and internet interventions improve mental health and wellbeing? |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
Depression is the primary cause of disability in Australia. It has been argued that a substantial percentage of the disease burden associated with depression could be averted with the delivery of evidence-based treatments. However, to succeed, such a program would need to develop feasible methods for delivery and to consider consumer treatment preferences. Many consumers prefer psychological and physical activity interventions and self-help modes of delivery. Peer-to-peer mutual support groups, and internet support groups (ISGs) in particular are a popular form of self help for depression. ISGs are highly accessible and consumers report they are helpful in reducing their depressive symptoms. However, the efficacy of ISGs has not been established. The current study seeks to evaluate the efficacy of an internet intervention for depression and an ISG both as independent interventions and in combination.
The study will evaluate the effect and relative effects of the D-couch (an automated internet intervention on depression) and Talking Point (an internet support group) interventions on depressive symptoms, social support, self-esteem, quality of life, depression literacy, stigma and help-seeking in people with depression. The primary hypothesis is that: D-couch and Talking Point will each be associated with a greater reduction in depression symptoms from baseline to post-intervention than the control. Secondary hypotheses are that: 1. The magnitude of improvement in depression will be greater for: 1.1. The internet conditions combined (D-couch and Talking Point) than for either condition alone; and 1.2. D-couch compared to Talking Point 2. Talking Point participants will show a greater increase in perceived social support and self-esteem than non-Talking Point participants at post-test 3. D-couch and Talking Point will each be associated with improved quality of life, and decreased anxiety, disability and stigma. Both interventions will also be associated with improved depression literacy, but the effect will be greater for D-couch. 4. Both D-couch and Talking Point will be associated with an increase in empowerment but the effect of empowerment will be greater for Talking Point 5. Adherence will be greater among D-couch participants with access to Talking Point than for D-couch participants without access to the Internet support group |
| Ethics approval | Ethics approval received from the Australian National University Human Research Ethics Committee on the 15th December 2007 (ref: 2007/2259). |
| Study design | Randomised controlled trial |
| Countries of recruitment | Australia |
| Disease/condition/study domain | Depression |
| Participants - inclusion criteria |
1. Aged 18 - 65 years, either sex
2. Evidence of psychological distress determined through screening questionnaire 3. Access to the internet at home 4. Willingness to participate in the trial |
| Participants - exclusion criteria |
1. Current/prior participation in a project conducted by the Centre for Mental Health Research
2. Report that they are currently receiving treatment from a mental health professional or support group |
| Anticipated start date | 12/05/2008 |
| Anticipated end date | 30/03/2010 |
| 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 | 500 |
| Interventions |
This study involves two active interventions and an attention-matched placebo (control) described below:
1. Intervention group one: D-couch: a multi-media internet application on depression comprising of a depression literacy module and an active self-help module. The depression literacy module contains information about the symptoms and types of depression and their diagnosis, sources of help, statistical information about the prevalence and disability burden associated with depression, depression risk factors, and evidence-based medical, psychological and lifestyle treatments for depression based on updated systematic reviews and clinical practice guidelines. The self help module comprises online versions of treatments amendable to delivery online and known to be effective in face-to-face therapy or as bibliotherapy. These include: 1.1. Cognitive behaviour therapy 1.2. Interpersonal therapy 1.3. Applied relaxation 1.4. Problem solving, and 1.5. Physical activity 2. Intervention group two: Talking Point: an internet support group which uses a bulletin board format for discussions. 3. Control group: HealthWatch: the control condition. An internet application comprising open ended questions that probe health factors that might be related to depression (e.g. work habits and stress, nutrition). Participants receive one of the above conditions or a combination of D-couch and Talking Point. Each program is delivered over 12 weeks. |
| Primary outcome measure(s) |
Depressive symptoms: Centre for Epidemiology Studies - Depression (CES-D) 20-item self-report measure of depression severity.
Outcomes will be measured at baseline, post-intervention (three months), six-month follow-up and 12-month follow-up. |
| Secondary outcome measure(s) |
1. Anxiety symptoms: Penn State Worry Questionnaire (PSWQ)
2. Quality of life: EUROHIS-QOL - 8-item index 3. Disability: 'Days Out of Role' questions adapted from US National Comorbidity Survey 4. Depression knowledge: 4.1. D-Lit 21-item measure of depression literacy 4.2. An additional measure of depression treatment knowledge 5. Perceived social support: 5.1. Medical Outcomes Study Social Support Survey (MOS) 5.2. UCLA Loneliness Scale 6. Stigma: Depression Stigma Scale 7. Help seeking: purpose developed items 8. Self esteem: Rosenberg Self-esteem Scale 9. Empowerment: 9.1. Empowerment scale: Power-powerlessness subscale 9.2. Participation in healthcare measure 10. Satisfaction and user perceived benefits Outcomes will be measured at baseline, post-intervention (three months), six-month follow-up and 12-month follow-up. |
| Sources of funding | National Health and Medical Research Council (Australia) - grant to the Centre for Mental Health Research |
| Trial website | |
| Publications | |
| Contact name | Dr Kathy Griffiths |
| Address |
Centre for Mental Health Research
Australian National University |
| City/town | Canberra |
| Zip/Postcode | 0200 |
| Country | Australia |
| Tel | +61 (0)2 6125 9723 |
| Fax | +61 (0)2 6125 0733 |
| Kathy.Griffiths@anu.edu.au | |
| Sponsor | Centre for Mental Health Research, Australian National University (Australia) |
| Address | Building 63 |
| City/town | Canberra |
| Zip/Postcode | 0200 |
| Country | Australia |
| Tel | +61 (0)2 6125 2741 |
| Fax | +61 (0)2 6125 0733 |
| cmhr@anu.edu.au | |
| Sponsor website: | http://www.anu.edu.au |
| Date applied | 08/04/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
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