Depression Clinical Trial
— REBOOTOfficial title:
Randomised Controlled Trial of an Established Direct to Public Peer Support and E-therapy Programme (Big White Wall) Versus Information to Aid Self-management of Depression and Anxiety.
A randomised controlled trial to compare the effect on wellbeing of an online peer review website (Big White Wall) compared to freely available online information (NHS Moodzone) for people with depression and anxiety.
Status | Recruiting |
Enrollment | 2200 |
Est. completion date | December 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Aged 16+ - Live in the County of Nottinghamshire, including Nottingham City - Scores between10-20 on the Personal Health Questionnaire (PHQ9) and/or 10+ on Genral Anxiety Disorder Scale (GAD7) - Access to internet through a pc or smartphone (Windows, iOS, Android) - Able and willing to give informed consent Exclusion Criteria: - Scores 21 or more on the PHQ-9 (severe depression) - And /Or Scores 2 or 3 on PHQ-9 item "thoughts that you would be better off dead or of hurting yourself in some way". - Participant does not feel that they are sufficiently proficient in the use of the English Language (BWW and Moodzone are only available in English) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals Nhs Trust | Nottingham | Nottinghamshire |
United Kingdom | Nottinghamshire Healthcare NHS foundation Trust. | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196. — View Citation
Crisp D, Griffiths K, Mackinnon A, Bennett K, Christensen H. An online intervention for reducing depressive symptoms: secondary benefits for self-esteem, empowerment and quality of life. Psychiatry Res. 2014 Apr 30;216(1):60-6. doi: 10.1016/j.psychres.2014.01.041. Epub 2014 Feb 3. — View Citation
Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry. 2010 Dec 30;10:113. doi: 10.1186/1471-244X-10-113. Review. — View Citation
Happonen AP, Kaipainen K, Väätänen A, Kinnunen ML, Myllymäki T, Lappalainen P, Tuomela H, Rusko H, Mattila E, Lappalainen R, Korhonen I. A concept to empower self-management of psychophysiological wellbeing: preliminary user study experiences. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:312-5. doi: 10.1109/IEMBS.2009.5333549. — View Citation
Mojtabai R, Olfson M, Sampson NA, Jin R, Druss B, Wang PS, Wells KB, Pincus HA, Kessler RC. Barriers to mental health treatment: results from the National Comorbidity Survey Replication. Psychol Med. 2011 Aug;41(8):1751-61. doi: 10.1017/S0033291710002291. Epub 2010 Dec 7. — View Citation
Spiers N, Bebbington P, McManus S, Brugha TS, Jenkins R, Meltzer H. Age and birth cohort differences in the prevalence of common mental disorder in England: National Psychiatric Morbidity Surveys 1993-2007. Br J Psychiatry. 2011 Jun;198(6):479-84. doi: 10.1192/bjp.bp.110.084269. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Client Service Receipt Inventory (CSRI) | Health Economics Measure | Baseline, 6, 12 & 26 weeks | |
Primary | Warwick-Edinburgh Mental Well-being Scale - 14 Item | Change on the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) from baseline to week 6 | 6 weeks | |
Secondary | Warwick-Edinburgh Mental Well-being Scale - 14 Item | Maintenance of effect | 12 and 26 weeks | |
Secondary | Generalised Anxiety Disorder 7 Item Scale (GAD-7) | Change in score on GAD7 at 6, 12 & 26 weeks | 6, 12 & 26 weeks | |
Secondary | Personal Health Questionnaire 9 Item (PHQ-9) 11 | Change in score at 6, 12 & 26 weeks | 6, 12 & 26 weeks | |
Secondary | SF-12 v2 Health Survey 12 | Change in score at 6, 12 & 26 weeks | 6, 12 & 26 weeks | |
Secondary | Work and Social Adjustment Scale 8 Item - Social Function 13 | Change in score at 6, 12 & 26 weeks | 6, 12 & 26 weeks | |
Secondary | 8-item social support measure14 | Change in score at 6, 12 & 26 weeks | 6, 12 & 26 weeks | |
Secondary | 12-item Brugha Inventory of Life Events15 | Change in score at 26 weeks | 26 weeks | |
Secondary | 8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS | Change in score at 6, 12 & 26 weeks | 26 weeks |
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