Condition category
Mental and Behavioural Disorders
Date applied
28/03/2013
Date assigned
15/07/2013
Last edited
05/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Approximately 4-13% of the population are thought to engage in Deliberate Self Harming behaviour (DSH) (self-poisoning or self-injury), irrespective of the purpose of the act. DSH is commonly associated with Borderline Personality Disorder (BPD), a form of personality disorder. About 70-75% of people with this, are engaged in such behaviour. However, DSH is also associated with other personality disorders and psychiatric disorders and may also be seen in general population. As such, it is important that treatments for DSH are tested with a broad range of participants. Although Dialectical Behaviour Therapy (DBT) has repeatedly been shown to be helpful in reducing hospital utilisation and self-harming behaviours among those with a BPD, there has been limited research on how good it is with a broader range of participants. The aim of this study was to find out the impact of 12-months of DBT, with a broad range of participants who engaged in DSH.

Who can participate?
We recruited participants who had at least a one-year history of DSH, with a minimum of 6 self-harming incidents in the previous 12-months.

What does the study involve?
All participants had four preliminary therapy sessions to find out about their self-harming behaviour and to get them used to the demands of DBT treatment. Depending on DBT therapist availability, this assessment period was followed by a 12-month period of treatment (DBT) or a 12-month wait for DBT (WLC) whilst receiving standard NHS care. Following their 12-month wait, participants in the WLC group were also offered one-year of DBT. Both groups completed self-report measures before and after the initial 12-month period, and after 12 and 24 months. The number of patients admitted to the hospital, their duration of hospital stay and the number of A&E admissions, for the 6 months before the study (baseline), during the study, and up to 24-months after the study was collected.

What are the possible benefits and risks of participating?
The benefits of participation were potential reduction in hospital admissions, self-harm and mental disorders. Possible risks to participants were problems associated with their difficulties whilst waiting for DBT, or not benefiting from DBT.

Where is the study run from?
Intensive Psychological Therapies Service, Dorset HealthCare Trust, UK

When is the study starting and how long is it expected to run for?
June 2000 to May 2006

Who is funding the study?
Dorset HealthCare NHS Trust (UK)

Who is the main contact?
Prof. Sue Clarke
Susan.clarke@dhuft.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Susan Clarke

ORCID ID

Contact details

University Department of Mental Health
St Ann's Hospital
69 Haven Road
Poole
Dorset
BH13 7LN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hospital utilisation by self-harming participants: a waiting list control evaluation of dialectical behaviour therapy

Acronym

Study hypothesis

This study predicted that there would be a greater reduction in hospital utilisation amongst participants who completed 12-months of Dialectical Behaviour Therapy (DBT) compared to participants waiting for DBT (WLC) for a 12-month period. Additionally, psychopathology, distress and self-harm were predicted to improve in the DBT condition compared to the WLC condition.

Ethics approval

East Dorset Local Research Ethics Committee, 25/05/2000, LREC approval number 50/00/B

Study design

Quasi-experimental non-randomised waiting-list control study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Deliberate self-harm / Personality Disorders

Intervention

Dialectical Behaviour Therapy (DBT) Following the four preliminary sessions, outlined above, the intervention group received 12-months of DBT, in keeping with the principles described by Linehan (1993). DBT was delivered by experienced therapists who had all completed a DBT Intensive Training (British Isle DBT Training Limited). Treatment consisted of weekly one-to-one sessions, a skills training group, telephone skills coaching, and a consultation team meeting.

Waiting List Control (WLC) Following the four preliminary sessions, the WLC participants received all the usual benefits associated with standard NHS care during the assessment period. This typically comprised care from a community mental health team, clinical services and contact with a general practitioner. Following their 12-month wait, the WLC participants were offered 12-months of DBT, described above.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The frequency and duration of all inpatient admissions, and frequency of A&E admissions, were measured for 6 monthly periods for the 6 months before the study, the study period, and up to 24-months after the intervention. This was collected by using the Dorset HealthCare Trust Participant Administration System.

Secondary outcome measures

1. Millon Clinical Multi-axial Inventory (MCMI-III). This assessed if a client had any of 10 Clinical Syndromes and 14 Personality Patterns, by answering true or false statement questions.
2. Clinical Outcomes in Routine Evaluation (CORE). This assessed a clientsÂ’ level of risk to themselves and others, and an overall global distress score, using a 5-point likert scale.
3. Dissociation Questionnaire (DisQ). This measured the amount of dissociation felt by a client, using a 5-point likert scale.
4. Deliberate self-harm. Measured on a 9-point likert scale that rated the frequency of self-harming behaviour over the previous year.
5. Service Satisfaction Scale (SSS-30) was used to assess client satisfaction with the service, using a 5-point likert scale.

All were self-report measures and were measured before and after the study period, and at 12- and 24-month follow-up.

Overall trial start date

01/06/2000

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over, men and women.
2. Referrals to the Intensive Psychological Therapies Service (IPTS).
3. History of DSH for at least a year, with a minimum of at least 6 self-harming incidents in the last year (Kreitman, 1977).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. On-going in-patient care.
2. Drug or alcohol dependence (DSM-IV, 1994).
3. A psychotic disorder (DSM-IV, 1994).

Recruitment start date

01/06/2000

Recruitment end date

01/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Ann's Hospital
Dorset
BH13 7LN
United Kingdom

Sponsor information

Organisation

Dorset HealthCare University NHS Foundation Trust (UK)

Sponsor details

11 Shelley Road
Boscombe
Bournemouth
Dorset
BH1 4JQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.dorsethealthcare.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Dorset HealthCare University NHS Foundation Trust (UK) - Research and Development budget.

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

Publication citations

Additional files

Editorial Notes

05/07/2016: No publications found, verifying study status with principal investigator.