Randomised controlled trial of the effectiveness of Big White Wall compared to other online support

Not Applicable

Completed

• Conditions: Specialty: Mental Health, Primary sub-specialty: Depression; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders; Mental and Behavioural Disorders; Depression/Anxiety

• Registration Number: ISRCTN12673428
• Lead Sponsor: niversity of Nottingham

Brief Summary

2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29254909 2021 results in preprint https://doi.org/10.2196/23487 (added 19/02/2021) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33890858/ (added 26/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-01
• Study Completion: 2018-12-31
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

1. Aged 16 years and over
2. Live in the County of Nottinghamshire, including Nottingham City
3. Scores between 10-20 on the Personal Health Questionnaire (PHQ9); added 24/04/2018: and/or 10+ on GAD7
4. Access to internet through a PC or smartphone (Windows, iOS, Android)
5. Able and willing to give informed consent

Exclusion Criteria

1. Scores 20 or more on the PHQ-9 (severe depression)
2. Scores 2 or 3 on PHQ-9 item thoughts that you would be better off dead or of hurting yourself in some way
3. Participant does not feel that they are sufficiently proficient in the use of the English language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in self-rated well-being at 6 weeks after baseline using the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) at baseline, 3, 6, 12 and 26 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Maintenance of well-being is measured using the WEMWBS at baseline, 3, 6, 12 and 26 weeks<br> 2. Anxiety is measured using the 7-Item Generalised Anxiety Disorder Scale (GAD-7) at baseline, 3, 6, 12 and 26 weeks<br> 3. Levels of depression are measured using the 9-Item Personal Health Questionnaire (PHQ9-9) at baseline, 3, 6, 12 and 26 weeks<br> 4. Health Related Quality of Life is measured using the 12-item medical outcomes study short form health survey version 2.0 (SF-12v2) at baseline, 3, 6, 12 and 26 weeks<br> 5. Social support is measured using the Medical Outcomes Study 8-Item Social Support Survey at baseline, 3, 6, 12 and 26 weeks<br> 6. Social function is measured using the 8-item Work and Social Adjustment Scale (WSAS) at baseline, 3, 6, 12 and 26 weeks<br>