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Clinical Trials/NCT02771691
NCT02771691
Completed
Not Applicable

Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial

University of Edinburgh1 site in 1 country53 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deliberate Self-Harm
Sponsor
University of Edinburgh
Enrollment
53
Locations
1
Primary Endpoint
Self-harm and related hospital use as reported in National Health Service patient records
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This is a prospective parallel group design of group-based Mentalization-Based Therapy for Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the effectiveness of our recruitment strategies; compliance with protocol/procedures; trends towards reduced self-harm.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
November 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Self-harm behaviour in the past 6 months
  • In receipt of treatment from local Child and Adolescent Mental Health Services
  • Competent and willing to provide written, informed consent.

Exclusion Criteria

  • Severe learning disability or pervasive developmental disorder
  • Acute psychotic episode
  • Eating disorder in the absence of self-harm.
  • Non-English speaking
  • Current involvement in other ongoing treatment research

Outcomes

Primary Outcomes

Self-harm and related hospital use as reported in National Health Service patient records

Time Frame: 12 weeks

Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010)

Time Frame: 12 weeks

Study Sites (1)

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