ISRCTN - ISRCTN97185214: Staying Well After Depression: a randomised trial

Plain English Summary

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

Trial website

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

Contact information

Type

Scientific

Primary contact

Prof Mark Williams

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

SWAD

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient 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)

Condition

Recurrent depression

Intervention

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

Behavioural

Phase

Drug names

Primary outcome measure

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

01/10/2008

Overall trial end date

31/12/2011

Reason abandoned (if study stopped)

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/10/2008

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location