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Mentalization-Based Group Therapy for Adolescents

Primary Purpose

Deliberate Self-Harm

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mentalization-Based Group Therapy for Adolescents
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deliberate Self-Harm focused on measuring Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CAMHS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBT therapy plus treatment as usual

Treatment as usual alone

Arm Description

Mentalization based group treatment for adolescents plus standard care

Standard care provided by local Child and Adolescent Mental Health Services

Outcomes

Primary Outcome Measures

Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010)
Self-harm and related hospital use as reported in National Health Service patient records

Secondary Outcome Measures

Full Information

First Posted
April 25, 2016
Last Updated
June 3, 2019
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT02771691
Brief Title
Mentalization-Based Group Therapy for Adolescents
Official Title
Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deliberate Self-Harm
Keywords
Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBT therapy plus treatment as usual
Arm Type
Experimental
Arm Description
Mentalization based group treatment for adolescents plus standard care
Arm Title
Treatment as usual alone
Arm Type
No Intervention
Arm Description
Standard care provided by local Child and Adolescent Mental Health Services
Intervention Type
Other
Intervention Name(s)
Mentalization-Based Group Therapy for Adolescents
Primary Outcome Measure Information:
Title
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
Title
Self-harm and related hospital use as reported in National Health Service patient records
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CAMHS
City
Edinburgh
State/Province
Lothian
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33677832
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
31170947
Citation
Griffiths H, Duffy F, Duffy L, Brown S, Hockaday H, Eliasson E, Graham J, Smith J, Thomson A, Schwannauer M. Efficacy of Mentalization-based group therapy for adolescents: the results of a pilot randomised controlled trial. BMC Psychiatry. 2019 Jun 6;19(1):167. doi: 10.1186/s12888-019-2158-8. Erratum In: BMC Psychiatry. 2021 Mar 9;21(1):142.
Results Reference
derived

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Mentalization-Based Group Therapy for Adolescents

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