Deliberate Self-HarmNCT02771691
Mentalization-Based Group Therapy for Adolescents
A study testing Mentalization-Based Group Therapy for Adolescents in people with Deliberate Self-Harm, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Deliberate Self-Harm
- What is being tested?
- Mentalization-Based Group Therapy for Adolescents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial
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.
- Conditions
- Deliberate Self-Harm
- Being tested
- Mentalization-Based Group Therapy for Adolescents
- Keywords
- Adolescent
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization-Based Group Therapy for AdolescentsOther
| Study group | Role | What they receive |
|---|---|---|
| MBT therapy plus treatment as usual | Experimental | Mentalization based group treatment for adolescents plus standard care Receives: Other: Mentalization-Based Group Therapy for Adolescents |
| Treatment as usual alone | No intervention | Standard care provided by local Child and Adolescent Mental Health Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010)
Measured: 12 weeks
Self-harm and related hospital use as reported in National Health Service patient records
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deliberate Self-HarmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771691
- Sponsor's protocol ID
- ELHF10-595
- Status last verified
- Nov 2017
- First submitted
- 25 Apr 2016
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33677832Storebo 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.
PubMed 32368793Griffiths 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.
PubMed 31170947
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02771691
- Acronym / sponsor ID
- ELHF10-595
- Conditions
- Deliberate Self-Harm
- Keywords
- Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Feb 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBT therapy plus treatment as usual | Experimental | Other: Mentalization-Based Group Therapy for AdolescentsMentalization based group treatment for adolescents plus standard care |
| Treatment as usual alone | No intervention | –Standard care provided by local Child and Adolescent Mental Health Services |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization-Based Group Therapy for Adolescents | Other | MBT therapy plus treatment as usual |
Primary outcome
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
Self-harm and related hospital use as reported in National Health Service patient records
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Derived from this study: PubMed 33677832Witt 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.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 31170947Griffiths 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization-Based Group Therapy for Adolescents in people with Deliberate Self-Harm, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771691, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.