Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RCT of the Effectiveness of Big White Wall Compared to Other Online Support (REBOOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02902159
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Other: BWW Online Peer Support Other: NHS Moodzone Online Information Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official 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.
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: BWW
Free access to online peer support through BWW for 6 months
Other: BWW Online Peer Support
Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.

Experimental: MZ
Access to NHS Moodzone Information Only
Other: NHS Moodzone Online Information
Directed to access to online information from NHS Moodzone




Primary Outcome Measures :
  1. Warwick-Edinburgh Mental Well-being Scale - 14 Item [ Time Frame: 6 weeks ]
    Change on the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) from baseline to week 6


Secondary Outcome Measures :
  1. Warwick-Edinburgh Mental Well-being Scale - 14 Item [ Time Frame: 12 and 26 weeks ]
    Maintenance of effect

  2. Generalised Anxiety Disorder 7 Item Scale (GAD-7) [ Time Frame: 6, 12 & 26 weeks ]
    Change in score on GAD7 at 6, 12 & 26 weeks

  3. Personal Health Questionnaire 9 Item (PHQ-9) 11 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks

  4. SF-12 v2 Health Survey 12 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks

  5. Work and Social Adjustment Scale 8 Item - Social Function 13 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks

  6. 8-item social support measure14 [ Time Frame: 6, 12 & 26 weeks ]
    Change in score at 6, 12 & 26 weeks

  7. 12-item Brugha Inventory of Life Events15 [ Time Frame: 26 weeks ]
    Change in score at 26 weeks

  8. 8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS [ Time Frame: 26 weeks ]
    Change in score at 6, 12 & 26 weeks


Other Outcome Measures:
  1. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline, 6, 12 & 26 weeks ]
    Health Economics Measure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902159


Contacts
Layout table for location contacts
Contact: Catherine J Kaylor-Hughes, DPhil +441158232478 catherine.kaylor-hughes@nottingham.ac.uk
Contact: Mat Rawsthorne, BSc +44115 8232478 mat.rawsthorne@nottingham.ac.uk

Locations
Layout table for location information
United Kingdom
Nottinghamshire Healthcare NHS foundation Trust. Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Nottingham University Hospitals Nhs Trust Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Layout table for investigator information
Principal Investigator: Richard Morriss, MD CLAHRC-EM

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02902159     History of Changes
Other Study ID Numbers: CLAHRC-EM 16053
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
Stress
Low Mood
Mental Health
Peer Support
Online
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders