DepressionREBOOTNCT02902159
RCT of the Effectiveness of Big White Wall Compared to Other Online Support
A study testing BWW Online Peer Support and NHS Moodzone Online Information in people with Depression and Anxiety, run by University of Nottingham at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- BWW Online Peer Support and NHS Moodzone Online Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Nottinghamshire Healthcare NHS foundation Trust.
Nottingham, Nottinghamshire, NG3 6AA
- Recruiting
Nottingham University Hospitals Nhs Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
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.
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.
Read the detailed description
Introduction
Unipolar depression and anxiety are respectively the second and seventh leading causes of years lived with disability in the world among all health problems according to the World Health Organisation. Self-support methods of management of depression and anxiety through a population approach such as online therapy and peer support is attractive for a number of reasons including: the scale of the problem and the ability of current services to cope; providing choice about the management of their symptoms; creating personal empowerment; developing supportive social networks; recurrence prevention.
The use of public health interventions for physical conditions such as cigarette smoking, weight loss and diabetes is increasingly utilised and effective in reaching the wider public.
Big White Wall
Big White Wall (BWW) is a well-established digital service (website and apps) 3 that offers:
- Online assessment of mental health problems and physical co-morbidities
- Moderated on-line peer support
- Guided support and live therapy
It is based on public health principles, emphasises a recovery model to improve well-being and is based theoretically on a social model of depression emphasising autonomy, hopefulness and support.
There are no waiting lists, eligibility criteria and opening hours (available 24/7).
It operates a community principle that each person is supported within cultures of respect, tolerance, mutual learning and safety, and procedures such as specially trained counsellors employed by BWW as "wall guides" try to ensure that this principle is maintained.
Patterns of use are often short-term over 3 to 6 weeks but people often utilise BWW at times of further need with a substantial proportion using it for longer periods on a more regular basis. Over that time people with depression and anxiety show clinically important improvement.
The case for online peer support interventions Peer support internet interventions such as BWW take less effort for service users than internet guided cognitive behaviour therapy (CBT) as it allows the user to choose when and how to access it rather than be committed to a pre-defined course of treatment. The overall effectiveness of BWW may be in keeping with the social model of depression and anxiety from which the website was conceived; that the onset of depression or anxiety may be precipitated by insufficient social support during a time of self-perceived threat to a person's well-being from a life event. Conversely, relief from depression or anxiety may be found through increased social support and improved life events and security.
BWW can therefore guide its users towards appropriate psycho-social support as and when they require it, whilst retaining autonomy through making their own decisions about how to use that support.
An important aspect of BWW's public health approach is to reach out to isolated people with poor quality social support and a perceived threat to their wellbeing. It aims to provide a population based service that doesn't require a personal subscription so that the most disadvantaged are able to benefit. Currently BWW has been purchased by the armed forces, some universities and 25% of Clinical Commissioning groups (CCGs) throughout England which provides free access to 98% of users.
However for a wider uptake by commissioners locally and nationally the service must be tested in a randomised controlled trial (RCT) to understand who, when and how BWW is utilised and its' clinical and cost effectiveness, compared to online information alone.
Trial Objectives To use the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation including economics, Maintenance) to explore the efficacy and reach of an internet intervention (online peer support) compared to online information for people with depression and anxiety.
Use qualitative analysis to determine the engagement and experiences of the participants in the BWW arm of the study to understand the motivations for use, patterns and levels of engagement (e.g. active user versus 'lurker'), negative experiences and beliefs about efficacy and role in personal empowerment.
More specifically the trial objectives are:
- To determine the short-term clinical effectiveness of Big White Wall (BWW) versus the National Health Service (NHS) Choices Moodzone (MZ) website on well-being (primary outcome).
- To determine the number and representativeness of participants invited and eligible to receive BWW or the NHS Choices Moodzone website.
- To determine the number, percent and representativeness of NHS primary care practices and organisations, secondary care mental health, community and acute trust, third sector and social care organisations that referred people to either BWW or the NHS Choices Moodzone website
- To explore the implementation of the BWW programme including barriers and drivers to reach, effectiveness and adoption and an economic evaluation of its costs and cost effectiveness from personal, social and health care perspectives.
- To explore the maintenance of treatment effects on well-being, depressive symptoms, anxiety symptoms, quality of life and social function over 6 months in service users
- With Academic Helth Science Network (AHSN) East Midlands to record the take up by organisations and implementation (number, percent, representativeness in East Midlands) of BWW across the East Midlands after the trial has been completed
- Explore user engagement and experiences of BWW through qualitative interviews and text analysis
Expected duration in the trial is 6 months.
Implementation A managed network of practice will be established ideally with representation from the mental health leads from Nottingham City and Nottinghamshire CCGs and public health together with the User consultant and a GP Knowledge Broker as well as key members of National Institute of Health Research (NIHR) MindTech and the study team. This network will ensure that both the engagement strategy and the research project itself are optimised and that important learning on implementation is collected. The results of this RE-AIM study will provide a rich database of information to inform CCGs and Health and Wellbeing Boards on who BWW and other digital mental health services might reach Access to BWW across the East Midlands will depend on commissioning decisions at a public health and primary care level. At the end of the study we will work with AHSN East Midlands and Public Health England to present these findings to Directors of Public Health and mental health leads for each CCG or consortium of CCGs, Healthwatch representatives and mental health providers in the East Midlands together with a directory of alternative providers of similar services.
- Conditions
- Depression, Anxiety
- Being tested
- BWW Online Peer Support, NHS Moodzone Online Information
- Keywords
- Stress, Low Mood, Mental Health, Peer Support, Online
- Medical subject headings
- Depression, Anxiety Disorders, Consciousness Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWW Online Peer SupportOther
Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.
NHS Moodzone Online InformationOther
Directed to access to online information from NHS Moodzone
| Study group | Role | What they receive |
|---|---|---|
| BWW | Experimental | Free access to online peer support through BWW for 6 months Receives: Other: BWW Online Peer Support |
| MZ | Experimental | Access to NHS Moodzone Information Only Receives: Other: NHS Moodzone Online Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (8)
Warwick-Edinburgh Mental Well-being Scale - 14 Item
Maintenance of effect
Measured: 12 and 26 weeks
Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Change in score on GAD7 at 6, 12 \& 26 weeks
Measured: 6, 12 & 26 weeks
Personal Health Questionnaire 9 Item (PHQ-9) 11
Change in score at 6, 12 \& 26 weeks
Measured: 6, 12 & 26 weeks
SF-12 v2 Health Survey 12
Change in score at 6, 12 \& 26 weeks
Measured: 6, 12 & 26 weeks
Work and Social Adjustment Scale 8 Item - Social Function 13
Change in score at 6, 12 \& 26 weeks
Measured: 6, 12 & 26 weeks
8-item social support measure14
Change in score at 6, 12 \& 26 weeks
Measured: 6, 12 & 26 weeks
12-item Brugha Inventory of Life Events15
Change in score at 26 weeks
Measured: 26 weeks
8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS
Change in score at 6, 12 \& 26 weeks
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Morriss, MD, Principal investigator, CLAHRC-EM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902159
- Sponsor's protocol ID
- CLAHRC-EM 16053
- Acronym
- REBOOT
- Status last verified
- Feb 2018
- First submitted
- 12 Sep 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24534125Spiers 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.
PubMed 21628710Andrews 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.
PubMed 20967242Gulliver 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.
PubMed 21192795Mojtabai 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.
PubMed 21134315Happonen 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.
PubMed 19964215
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02902159
- Acronym / sponsor ID
- REBOOT / CLAHRC-EM 16053
- Conditions
- Depression, Anxiety
- Keywords
- Stress, Low Mood, Mental Health, Peer Support, Online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction
Unipolar depression and anxiety are respectively the second and seventh leading causes of years lived with disability in the world among all health problems according to the World Health Organisation. Self-support methods of management of depression and anxiety through a population approach such as online therapy and peer support is attractive for a number of reasons including: the scale of the problem and the ability of current services to cope; providing choice about the management of their symptoms; creating personal empowerment; developing supportive social networks; recurrence prevention.
The use of public health interventions for physical conditions such as cigarette smoking, weight loss and diabetes is increasingly utilised and effective in reaching the wider public.
Big White Wall
Big White Wall (BWW) is a well-established digital service (website and apps) 3 that offers:
- Online assessment of mental health problems and physical co-morbidities
- Moderated on-line peer support
- Guided support and live therapy
It is based on public health principles, emphasises a recovery model to improve well-being and is based theoretically on a social model of depression emphasising autonomy, hopefulness and support.
There are no waiting lists, eligibility criteria and opening hours (available 24/7).
It operates a community principle that each person is supported within cultures of respect, tolerance, mutual learning and safety, and procedures such as specially trained counsellors employed by BWW as "wall guides" try to ensure that this principle is maintained.
Patterns of use are often short-term over 3 to 6 weeks but people often utilise BWW at times of further need with a substantial proportion using it for longer periods on a more regular basis. Over that time people with depression and anxiety show clinically important improvement.
The case for online peer support interventions Peer support internet interventions such as BWW take less effort for service users than internet guided cognitive behaviour therapy (CBT) as it allows the user to choose when and how to access it rather than be committed to a pre-defined course of treatment. The overall effectiveness of BWW may be in keeping with the social model of depression and anxiety from which the website was conceived; that the onset of depression or anxiety may be precipitated by insufficient social support during a time of self-perceived threat to a person's well-being from a life event. Conversely, relief from depression or anxiety may be found through increased social support and improved life events and security.
BWW can therefore guide its users towards appropriate psycho-social support as and when they require it, whilst retaining autonomy through making their own decisions about how to use that support.
An important aspect of BWW's public health approach is to reach out to isolated people with poor quality social support and a perceived threat to their wellbeing. It aims to provide a population based service that doesn't require a personal subscription so that the most disadvantaged are able to benefit. Currently BWW has been purchased by the armed forces, some universities and 25% of Clinical Commissioning groups (CCGs) throughout England which provides free access to 98% of users.
However for a wider uptake by commissioners locally and nationally the service must be tested in a randomised controlled trial (RCT) to understand who, when and how BWW is utilised and its' clinical and cost effectiveness, compared to online information alone.
Trial Objectives To use the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation including economics, Maintenance) to explore the efficacy and reach of an internet intervention (online peer support) compared to online information for people with depression and anxiety.
Use qualitative analysis to determine the engagement and experiences of the participants in the BWW arm of the study to understand the motivations for use, patterns and levels of engagement (e.g. active user versus 'lurker'), negative experiences and beliefs about efficacy and role in personal empowerment.
More specifically the trial objectives are:
- To determine the short-term clinical effectiveness of Big White Wall (BWW) versus the National Health Service (NHS) Choices Moodzone (MZ) website on well-being (primary outcome).
- To determine the number and representativeness of participants invited and eligible to receive BWW or the NHS Choices Moodzone website.
- To determine the number, percent and representativeness of NHS primary care practices and organisations, secondary care mental health, community and acute trust, third sector and social care organisations that referred people to either BWW or the NHS Choices Moodzone website
- To explore the implementation of the BWW programme including barriers and drivers to reach, effectiveness and adoption and an economic evaluation of its costs and cost effectiveness from personal, social and health care perspectives.
- To explore the maintenance of treatment effects on well-being, depressive symptoms, anxiety symptoms, quality of life and social function over 6 months in service users
- With Academic Helth Science Network (AHSN) East Midlands to record the take up by organisations and implementation (number, percent, representativeness in East Midlands) of BWW across the East Midlands after the trial has been completed
- Explore user engagement and experiences of BWW through qualitative interviews and text analysis
Expected duration in the trial is 6 months.
Implementation A managed network of practice will be established ideally with representation from the mental health leads from Nottingham City and Nottinghamshire CCGs and public health together with the User consultant and a GP Knowledge Broker as well as key members of National Institute of Health Research (NIHR) MindTech and the study team. This network will ensure that both the engagement strategy and the research project itself are optimised and that important learning on implementation is collected. The results of this RE-AIM study will provide a rich database of information to inform CCGs and Health and Wellbeing Boards on who BWW and other digital mental health services might reach Access to BWW across the East Midlands will depend on commissioning decisions at a public health and primary care level. At the end of the study we will work with AHSN East Midlands and Public Health England to present these findings to Directors of Public Health and mental health leads for each CCG or consortium of CCGs, Healthwatch representatives and mental health providers in the East Midlands together with a directory of alternative providers of similar services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BWW | Experimental | Other: BWW Online Peer SupportFree access to online peer support through BWW for 6 months |
| MZ | Experimental | Other: NHS Moodzone Online InformationAccess to NHS Moodzone Information Only |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BWW Online Peer SupportFree access to BWW online peer support and other services offered by them (except live therapy), for 6 months. | Other | BWW |
| NHS Moodzone Online InformationDirected to access to online information from NHS Moodzone | Other | MZ |
Primary outcome
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
8 secondary outcomes
Warwick-Edinburgh Mental Well-being Scale - 14 Item
Time frame: 12 and 26 weeks
Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Time frame: 6, 12 & 26 weeks
Personal Health Questionnaire 9 Item (PHQ-9) 11
Time frame: 6, 12 & 26 weeks
SF-12 v2 Health Survey 12
Time frame: 6, 12 & 26 weeks
Work and Social Adjustment Scale 8 Item - Social Function 13
Time frame: 6, 12 & 26 weeks
8-item social support measure14
Time frame: 6, 12 & 26 weeks
12-item Brugha Inventory of Life Events15
Time frame: 26 weeks
8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Background: PubMed 24534125Crisp 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.
- Background: PubMed 21628710Spiers 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.
- Background: PubMed 20967242Andrews 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.
- Background: PubMed 21192795Gulliver 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.
- Background: PubMed 21134315Mojtabai 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.
- Background: PubMed 19964215Happonen 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Morriss, MD principal investigator
CLAHRC-EM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWW Online Peer Support and NHS Moodzone Online Information in people with Depression and Anxiety, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine J Kaylor-Hughes, DPhil (+441158232478, catherine.kaylor-hughes@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warwick-Edinburgh Mental Well-being Scale - 14 Item (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902159, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.