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

NCT03035110 | Completed

• 1 other identifier: 205350
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Self-Injurious Behavior

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Dialectical Behavioural Therapy (DBT) skills group

EXPERIMENTAL

Four group sessions, based on DBT, over two weeks, with a group of four to eight participants in attendance located on the hospital ward where the participant is a patient.

Behavioral: Dialectical Behavioural Therapy (DBT) based skills groups

Interventions

Dialectical Behavioural Therapy (DBT) based skills groups BEHAVIORAL

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.

Dialectical Behavioural Therapy (DBT) skills group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Essex: lead

Study Sites (1)

Goodmayes Hospital

Ilford, Essex, IG3 8XJ, United Kingdom

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: April 18, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)