A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings

Self-Injurious Behavior Clinical Trial

Official title:

A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035110
• Other study ID #: 205350
• Status: Completed
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: June 2018
• Source: University of Essex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current research is being undertaken as part of a professional doctorate in clinical psychology, which aims to evaluate the feasibility of a group programme to address self-harm within 23 days, to provide evidence for a controlled trial. The intervention will include four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy. Specifically the aims are to determine 1) means and a standard deviation for two pre and post treatment outcome measures in order to estimate sample size for the main study, 2) the need for an inpatient intervention for self-harm measured by number of participants eligible and accepting of the treatment, 3) retention of participants for 4 groups given the predicted short stays of patients on wards, and 4) the acceptability of the research process for this client group through feedback.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants will be screened by their allocated clinician and included if they are aged between 18-65

• admitted to hospital

• have a history of or engaged in at least one episode of self-harm, iv) have capacity to understand the information sheet.

Exclusion Criteria:

• Participants will be screened by clinicians and they will exclude people if i) they are Non-English speakers (due to translation costs)

• they lack the capacity to give informed consent (assessed by their key clinician)

• their symptoms prevent them from concentrating for an hour at a time (i.e. severe thought disorder), and therefore not benefiting from the group (assessed by their key clinician)

Related Conditions & MeSH terms

• Self-Injurious Behavior

Intervention

Behavioral:
• Dialectical Behavioural Therapy (DBT) based skills groups
Dialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder.

Locations

Country	Name	City	State
United Kingdom	Goodmayes Hospital	Ilford	Essex

Sponsors (1)

Lead Sponsor	Collaborator
University of Essex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Inventory of Statements About Self-Injury (ISAS)	ISAS is a self-report measure designed to assess the function and frequency of deliberate self-harm. It will be administered pre- and post-intervention.	23 days
Primary	The Distress Tolerance Scale (DTS)	The DTS consists of 15 items, which measure a person's appraisal of their emotional distress, their ability to tolerate this distress and any regulation efforts to alleviate it. It will be administered pre- and post-intervention.	23 days