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

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ClinicalTrials.gov Identifier: NCT03035110
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Self-Injurious Behavior Behavioral: Dialectical Behavioural Therapy (DBT) based skills groups

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-harm
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dialectical Behavioural Therapy (DBT) skills group
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
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.


Outcome Measures

Primary Outcome Measures :
  1. The Inventory of Statements About Self-Injury (ISAS) [ Time Frame: 23 days ]
    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.

  2. The Distress Tolerance Scale (DTS) [ Time Frame: 23 days ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035110


Contacts
Contact: Sarah Fife, BSc, MSc 00447791255243 sefife@essex.ac.uk
Contact: Sarah Research Governance and Planning Manager 00441206873561 sarahm@essex.ac.uk

Locations
United Kingdom
Goodmayes Hospital Recruiting
Ilford, Essex, United Kingdom, IG3 8XJ
Contact: Lisa Wood, Clinical Psychology Doctorate    00441206874143    lisa.wood@nelft.nhs.uk   
Sponsors and Collaborators
University of Essex
More Information

Responsible Party: University of Essex
ClinicalTrials.gov Identifier: NCT03035110     History of Changes
Other Study ID Numbers: 205350
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms