Deliberate Self-Harm Clinical Trial
Official title:
Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial
| NCT number | NCT02771691 |
| Other study ID # | ELHF10-595 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2016 |
| Est. completion date | November 2017 |
| Verified date | November 2017 |
| Source | University of Edinburgh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | CAMHS | Edinburgh | Lothian |
| Lead Sponsor | Collaborator |
|---|---|
| University of Edinburgh | NHS Lothian |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) | 12 weeks | ||
| Primary | Self-harm and related hospital use as reported in National Health Service patient records | 12 weeks |
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