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Completed

NCT Number: NCT03035110

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goodmayes Hospital

Ilford, Essex, IG3 8XJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Essex

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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