Psychological mechanisms in suicidal behaviour

ISRCTN	ISRCTN55225822
DOI	https://doi.org/10.1186/ISRCTN55225822
Secondary identifying numbers	PRG/06/01

Submission date: 03/03/2005
Registration date: 22/07/2005
Last edited: 28/11/2012

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

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

Contact information

Prof J. Mark G. Williams
Scientific

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

Phone	+44 (0)1865 226445
Email	mark.williams@psych.ox.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2005
Completion date	01/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	12
Key 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)
Key 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)
Date of first enrolment	01/05/2005
Date of final enrolment	01/12/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oxford University

Oxford
OX3 7JX
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone	+44 (0)1865 270143
Email	researchservices@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	preliminary results	01/04/2008	Yes	No
Results article	results	01/12/2008	Yes	No
Results article	results	01/06/2009	Yes	No