NCT02902159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

September 12, 2016

Last Update Submit

February 14, 2018

Conditions

Keywords

StressLow MoodMental HealthPeer SupportOnline

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Warwick-Edinburgh Mental Well-being Scale - 14 Item

    12 and 26 weeks

  • Generalised Anxiety Disorder 7 Item Scale (GAD-7)

    6, 12 & 26 weeks

  • Personal Health Questionnaire 9 Item (PHQ-9) 11

    6, 12 & 26 weeks

  • SF-12 v2 Health Survey 12

    6, 12 & 26 weeks

  • Work and Social Adjustment Scale 8 Item - Social Function 13

    6, 12 & 26 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Client Service Receipt Inventory (CSRI)

    Baseline, 6, 12 & 26 weeks

Study Arms (2)

BWW

EXPERIMENTAL

Free access to online peer support through BWW for 6 months

Other: BWW Online Peer Support

MZ

EXPERIMENTAL

Access to NHS Moodzone Information Only

Other: NHS Moodzone Online Information

Interventions

Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.

BWW

Directed to access to online information from NHS Moodzone

MZ

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nottinghamshire Healthcare NHS foundation Trust.

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

RECRUITING

Nottingham University Hospitals Nhs Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (6)

  • 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.

    PMID: 24534125BACKGROUND
  • 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.

    PMID: 21628710BACKGROUND
  • 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.

    PMID: 20967242BACKGROUND
  • 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.

    PMID: 21192795BACKGROUND
  • 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.

    PMID: 21134315BACKGROUND
  • Happonen AP, Kaipainen K, Vaatanen A, Kinnunen ML, Myllymaki 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. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:312-5. doi: 10.1109/IEMBS.2009.5333549.

    PMID: 19964215BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersConsciousness DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersPersonal Satisfaction

Study Officials

  • Richard Morriss, MD

    CLAHRC-EM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations