ISRCTN ISRCTN97185214
DOI https://doi.org/10.1186/ISRCTN97185214
Secondary identifying numbers Protocol version 5 (6/5/09); 067797
Submission date
04/01/2010
Registration date
05/01/2010
Last edited
24/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.staying-well.org/information-sheet

Study website

Contact information

Prof Mark Williams
Scientific

Department of Psychiatry
University of Oxford
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Can be found at http://www.staying-well.org/information-sheet (Oxford) and http://stayingwell.bangor.ac.uk/participant_info.php.en?menu=1&catid=7164&subid=0 (Bangor)
Scientific titleModifying risk and severity of relapse in patients with recurrent depression at high suicide risk: translational randomised controlled trial
Study acronymSWAD
Study objectivesThat 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(s)Oxfordshire Research Ethics Committee (REC) C, 27/06/2008, ref: 08/H606/56
Health condition(s) or problem(s) studiedRecurrent depression
InterventionMindfulness-based cognitive therapy and cognitive psychoeducation as compared to ordinary care (treatment-as-usual).

Treatment duration: 8 weeks
Follow-up duration: 12 months
Intervention typeBehavioural
Primary outcome measureTime 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 measures1. 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 study start date01/10/2008
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300 after allowing for attrition
Key inclusion criteria1. 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
Key exclusion criteriaParticipants 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)
Date of first enrolment01/10/2008
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Oxford
Oxford
OX3 7JX
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom

Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 19/03/2010 Yes No
Results article results 01/02/2014 Yes No
Results article results 02/07/2014 Yes No