Condition category
Mental and Behavioural Disorders
Date applied
03/03/2005
Date assigned
22/07/2005
Last edited
28/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
This study aimed to examine the acceptability and mechanisms of action of Mindfulness-based Cognitive Therapy (MBCT) delivered to patients in remission, but with a history of serious suicidal thoughts or behaviour. The aim of the study was to explore the feasibility of delivering MBCT to this population, and the extent to which treatment with MBCT could reduce vulnerability to suicidal thoughts and behaviour through an examination of its effects on psychological factors linked to of suicidal vulnerability.

Who can participate?
Participants aged between 18 and 65 who were currently well but reported at least one prior episode of major depression accompanied by serious suicidal thoughts were recruited from general practitioners and local psychologists/psychiatrists and from the community. All participants were required to be well (no more than one week of minimal depressive symptoms in the past 8 weeks), and to have experienced no episodes of mania for at least 6 months. Additional exclusion criteria included current psychosis, obsessive compulsive disorder or eating disorder as their main problem, current deliberate self harm on a regular basis, a neurological disorder or an inability to complete assessments due to language difficulties or cognitive impairment.

What does the study involve?
Participants were interviewed using the Mini International Neuropsychiatric Interview to establish psychiatric history. Following this, participants completed a number of other assessment measures assessing aspects of cognitive vulnerability to depression and suicidality. These measures included assessment of residual symptoms of depression, mood-related impairments in problem solving and future thinking, autobiographical memory deficits, tendency to suppress unwanted thoughts and self-discrepancy (perceptions of distance between how one currently sees themselves and how one would like to be). Participants were then randomly allocated to either immediate treatment with MBCT or a waitlist condition. The measures were completed again at the end of treatment or waitlist phase. Following this the waitlist group received treatment with MBCT.

What are the possible benefits and risks of participating?
Benefits included the fact that all participants were offered treatment with Mindfulness Based Cognitive Therapy, either immediately or at the end of the waitlist phase of the study. Potential risks to participants related to the distress of reporting on prior psychiatric history and the inherent challenges of engaging in a therapeutic process designed to target vulnerability to recurrent depression and suicidality.

Where is the study run from?
Department of Psychiatry, University of Oxford

When is the study starting and how long is it expected to run for?
The study started in May 2005 and ended in December 2005

Who is funding the study?
The Wellcome Trust

Who is the main contact?
Professor Mark Williams
mark.williams@psych.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof J. Mark G. Williams

ORCID ID

Contact details

Oxford University
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 226445
mark.williams@psych.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PRG/06/01

Study information

Scientific title

Acronym

Study hypothesis

This is a preliminary (explanatory) trial to assess the immediate effects of Mindfulness-based Cognitive Therapy (MBCT) on cognitive reactivity (the tendency to react to small changes in mood with a catastrophic and rapidly escalating pattern of suicidal thinking).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Suicidality

Intervention

Treatment:
Mindfulness-Based Cognitive Therapy (MBCT): manualised, eight week treatment combining stress reduction techniques and cognitive therapy and Treatment As Usual (TAU)

Control:
Waiting List control and Treatment As Usual (TAU)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Depression
2. Frequency of thought suppression
3. Change in problem solving and future thinking following experimental induction of mood
4. Self-rated mindfulness
5. Discrepancy between actual and ideal self-guides
6. Specificity of autobiographical memory

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2005

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 64
2. History of major depression with suicidal ideation and/or suicidal behaviour
3. Not currently depressed or suicidal (at least eight weeks symptom free)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Visually impaired
2. Not fluent in English
3. Habitual self-damaging acts
4. Bipolar disorder
5. Schizophrenia
6. Active substance abuse
7. Eating disorder
8. Primary Obsessive Compulsive Disorder (OCD)

Recruitment start date

01/05/2005

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
researchservices@admin.ox.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 067797)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2008 preliminary results in http://www.ncbi.nlm.nih.gov/pubmed/17884176
2. 2008 results in http://link.springer.com/article/10.1007/s10608-008-9193-y/fulltext.html#Sec2
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19254446

Publication citations

  1. Preliminary results

    Williams JM, Alatiq Y, Crane C, Barnhofer T, Fennell MJ, Duggan DS, Hepburn S, Goodwin GM, Mindfulness-based Cognitive Therapy (MBCT) in bipolar disorder: preliminary evaluation of immediate effects on between-episode functioning., J Affect Disord, 2008, 107, 1-3, 275-279, doi: 10.1016/j.jad.2007.08.022.

  2. Results

    Hepburn SR, Crane C, Barnhofer T, Duggan DS, Fennell MJ, Williams JM, Mindfulness-based cognitive therapy may reduce thought suppression in previously suicidal participants: findings from a preliminary study., Br J Clin Psychol, 2009, 48, Pt 2, 209-215, doi: 10.1348/014466509X414970.

Additional files

Editorial Notes