A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Primary Purpose
Self-Injurious Behavior
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dialectical Behavioural Therapy (DBT) based skills groups
Sponsored by
About this trial
This is an interventional other trial for Self-Injurious Behavior
Eligibility Criteria
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)
Sites / Locations
- Goodmayes Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dialectical Behavioural Therapy (DBT) skills group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03035110
Brief Title
A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Official Title
A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Essex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Injurious Behavior
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behavioural Therapy (DBT) skills group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavioural Therapy (DBT) based skills groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Inventory of Statements About Self-Injury (ISAS)
Description
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.
Time Frame
23 days
Title
The Distress Tolerance Scale (DTS)
Description
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.
Time Frame
23 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Goodmayes Hospital
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG3 8XJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
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