Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Prof Mark Williams


Contact details

Department of Psychiatry
University of Oxford
Warneford Hospital
Warneford Lane
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol version 5 (6/5/09); 067797

Study information

Scientific title

Modifying risk and severity of relapse in patients with recurrent depression at high suicide risk: translational randomised controlled trial



Study hypothesis

That treatment with mindfulness-based cognitive therapy for depression, a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, delivered in addition to treatment as usual (TAU), will:
1. Reduce risk of relapse to major depression in recurrently depressed patients compared with TAU alone and cognitive psycho-education (CPE), a treatment of equal plausibility, and
2. Reduce incidence of suicidal symptoms in those with a history of suicidality compared with TAU alone

Ethics approval

Oxfordshire Research Ethics Committee (REC) C, 27/06/2008, ref: 08/H606/56

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Can be found at (Oxford) and (Bangor)


Recurrent depression


Mindfulness-based cognitive therapy and cognitive psychoeducation as compared to ordinary care (treatment-as-usual).

Treatment duration: 8 weeks
Follow-up duration: 12 months

Intervention type



Drug names

Primary outcome measures

Time to relapse or recurrence meeting DSM-IV criteria for major depression, assessed using the Structured Clinical Interview for DSM-IV (SCID). Occurrence of relapse/recurrence is assessed at all follow-up assessments, and 'return to treatment' will be treated as a relapse/recurrence if, in the judgment of a blind assessor, the participant has experienced exacerbation of symptoms that would have met the criteria for major depression in the absence of immediate treatment. In addition to diagnostic status, we assess severity of depression and hopelessness using a number of interview and self-report measures including the Hamilton Rating Scale for Depression, the Beck Depression Inventory and the Beck Hopelessness Scale, at all time points. These quantitative measures complement the dichotomised outcome of diagnosis.

Outcomes measured pre-treatment, post-treatment and at 3, 6, 9, and 12 months follow-up.

Secondary outcome measures

1. Cognitive measures relevant to risk of relapse/recurrence (mindfulness, self-compassion, rumination, self discrepancy, autobiographical memory, and executive capacity) are assessed before and immediately after the treatment as well as at the end of the follow-up, and will be used in an explanatory analysis to examine factors that mediate and moderate efficacy
2. Severity of suicidal ideation/behaviour both within and between episodes of depression during the follow-up period

Outcomes measured pre-treatment, post-treatment and at 3, 6, 9, and 12 months follow-up.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 18 years or over, and not older than 70 years due to the fact that depression in old age has often been found to be related to different factors than depression in earlier stages of life. Male or female.
2. Meeting enhanced Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a history of recurrent major depression, i.e. history of at least three episodes of depression, two of which must have occurred within the last five years, of which one must have occurred within the last two years. Although previous suicidality is recorded in detail (which allows stratification to be carried out on this basis) participants are not included/excluded from the study on the basis of their prior experience of suicidality.
3. Meeting the National Institute of Mental Health (NIMH) guidelines for recovery or remission at the time of baseline assessment. For the purposes of the trial participants are NOT deemed to be in recovery or remission (and hence are ineligible) if they report a week (or more) during the previous 8 weeks during which they experienced EITHER a core symptom of depression (depressed mood, anhedonia) or suicidal feelings AND at least one other symptom of depression, which together are not accounted for by bereavement or substances/general medical conditions, and which are accompanied by significant impairment in functioning.
4. Giving informed consent
5. Consent received from the participant's General Practitioner

Participant type


Age group




Target number of participants

300 after allowing for attrition

Participant exclusion criteria

Participants are excluded from the study if one or more of the following apply:
1. They have a history of schizophrenia, schizoaffective disorder, bipolar I disorder, current and severe substance abuse, organic mental disorder, pervasive developmental delay, a primary diagnosis of obsessive-compulsive disorder or eating disorder, or are currently regularly self-harming
2. They are showing a positive and continuing response to CBT
3. They have current psychotherapy or counseling more frequently than once per month
4. They are unable to complete the baseline research assessment (e.g. due to difficulties with English, visual impairment, or cognitive difficulties)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
United Kingdom

Sponsor information


University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
United Kingdom

Sponsor type




Funder type


Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in:
2014 results in:
2014 results in:

Publication citations

  1. Protocol

    Williams JM, Russell IT, Crane C, Russell D, Whitaker CJ, Duggan DS, Barnhofer T, Fennell MJ, Crane R, Silverton S, Staying well after depression: trial design and protocol., BMC Psychiatry, 2010, 10, 23, doi: 10.1186/1471-244X-10-23.

  2. Results

    Crane C, Barnhofer T, Duggan DS, Eames C, Hepburn S, Shah D, Williams JM, Comfort from suicidal cognition in recurrently depressed patients., J Affect Disord, 2014, 155, 241-246, doi: 10.1016/j.jad.2013.11.006.

  3. Results

    Radford S, Eames C, Brennan K, Lambert G, Crane C, Williams JM, Duggan DS, Barnhofer T, Trait mindfulness as a limiting factor for residual depressive symptoms: an explorative study using quantile regression, PLoS One, 2014 , 9, 7, e100022, doi: 10.1371/journal.pone.0100022.

Additional files

Editorial Notes