The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm (DSH)
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|ClinicalTrials.gov Identifier: NCT00694668|
Recruitment Status : Unknown
Verified November 2009 by Leiden University Medical Center.
Recruitment status was: Recruiting
First Posted : June 10, 2008
Last Update Posted : November 6, 2009
In recent years, there has been a marked rise in the frequency of young people engaging in Deliberate Self-Harm (DSH). DSH refers to all kinds of self-harming behaviour, with and without suicidal intent. Early identification and treatment of persons who engaged in DSH is important because every episode of DSH increases the risk of future episodes and, eventually, suicide. A number of comprehensive treatment programs have been developed and proven to be effective in reducing DSH in adults. Especially the modification of inadequate emotion regulation strategies seems to be essential in the prevention of future episodes of DSH. The first short-term results of a Dutch time-limited and structured individual cognitive-behavioral treatment (CBT) for DSH in adolescents and young adults also showed positive effects on repetition of DSH and associated problems.
To study the effects and costs of the total individual CBT package and one of the components of the total CBT treatment package (i.e. mindfulness training) in a group format compared to Treatment-as-Usual (TAU) on the short and long term.
Multi-center randomized controlled clinical trial with repeated measurements at baseline (M0),and posttreatment (M6)), 12 (M12) and 18 months (M18) after baseline.
Young persons aged 15-35 who recently have engaged in DSH and have been referred to the Leiden University Medical Centre, the mental health centre Rivierduinen or the University Medical Centre St. Radboud following an act of DSH will be invited to participate. Persons reporting severe psychiatric disorders requiring intensive inpatient treatment or serious cognitive impairments will be excluded.
Participants are randomly allocated to CBT, Mindfulness-Based Cognitive Therapy(MBCT) or Treatment-as-Usual (TAU). The CBT treatment consists of up to 12 weekly sessions of individual treatment mainly consisting of emotion regulations skills, cognitive restructuring, and behavioural skills training. The MBCT training consists of 8 2-hour sessions in a group format within a three months time frame.
The same outcome measures to assess the clinical effects of treatment as in the previous study will be used (repetition of DSH, depression (BDI-II), anxiety (SCL-90), self-concept(RSC-Q), and suicide cognitions (SCS)) allowing a historical comparison of treatment effectiveness across both randomized clinical trials. In addition at all assessments health-related quality of life, use of medical resources and loss of productivity will be assessed (EuroQol, VAS and TTO). In addition,problems in emotion regulation (an important risk mechanism for repetition of DSH) will be assessed before and after treatment.
Differences in societal costs (intervention, other (health) care and productivity)will be compared to differences in the frequency of DSH and quality adjusted life years (EuroQol, VAS and TTO).
Based on our previous study at least a medium effect of treatment on repetition of DSH may be expected. Assuming a medium effect of one of the treatments compared to TAU (delta =.75) and an attrition rate of about 20 %, at least 42 patients per study arm are needed to detect a minimal clinical relevant difference in repetition of DSH with a power of 80% and alpha set at .05.
|Condition or disease||Intervention/treatment||Phase|
|Self-Injurious Behavior||Behavioral: Cognitive Behavioral treatment Behavioral: Mindfulness based cognitive therapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||October 2012|
Cognitive Behavioural Treatment
Behavioral: Cognitive Behavioral treatment
Brief cognitive behavioral therapy (12 sessions)
Mindfulness Based Cognitive Therapy-training
Behavioral: Mindfulness based cognitive therapy
9 sessions MBCT in a group-format (up to 8 persons)
- Repetition of DSH, measured by the suicide attempt and self injury interview (SASII). Frequency, method and other characteristics of deliberate self-harm and suicide attempts are assessed. [ Time Frame: M0, M6, M12, M18 ]
- depression, as measured by the Beck depression Inventory II [ Time Frame: M0, M6, M12, M18 ]
- Anxiety, as measured by the symptom checklist '90 [ Time Frame: M0, M6, M12, M18 ]
- Hostility, as measured by the symptom checklist '90 [ Time Frame: M0, M6, M12, M18 ]
- Self-concept, as measured by the Robson self-concept questionnaire [ Time Frame: M0, M6, M12, M18 ]
- Suicidal cognitions, as measured by the suicidal cognitions scale [ Time Frame: M0, M6, M12, M18 ]
- QALYs, assessed by the EQ5D [ Time Frame: M0, M6, M12, M18 ]
- COSTS, assessed by a 6-monthly diary [ Time Frame: M0 - M6, M6 - M12, M12 - M18 ]
- Problem-solving skills, as measured by the Means Ends Problem-Solving Test [ Time Frame: M0, M6 ]
- Experimental avoidance, as measured by the Acceptance and Action Questionnaire [ Time Frame: M0, M6 ]
- difficulties in emotion-regulation, as measured by the difficulties in emotion regulation scale [ Time Frame: M0, M6 ]
- general tendency to ruminate, as measured by the Ruminative Response Scale [ Time Frame: M0, M6 ]
- mindfulness skills, as measured by the Five Facet Mindfulness Questionnaire [ Time Frame: M0, M6 ]
- pathological dissociation, as measured by the dissociative experiences scale - taxon [ Time Frame: M0, M6 ]
- Autobiographical memory, assessed by the autobiographical memory task [ Time Frame: M0, M6 ]
- worrying, as measured by the Penn State Worry Questionnaire [ Time Frame: M0 M6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694668
|Contact: Suzanne de Klerk, MSc.||31-71-527-3995||SKlerk@fsw.leidenuniv.nl|
|Contact: Anne van Giezen, Dr.||31-71-527-3729||Giezen@fsw.leidenuniv.nl|
|University Medical Centre St. Radboud||Recruiting|
|Nijmegen, Gelderland, Netherlands|
|Contact: Speckens, Prof. dr. firstname.lastname@example.org|
|Contact: de Klerk, MSc S.email@example.com|
|Leiden University Medical Centre||Recruiting|
|Leiden, Zuid-Holland, Netherlands|
|Contact: Anne van Giezen, PhD +31-71-527-3729 Giezen@fsw.leidenuniv.nl|
|Rivierduinen Mental Health Centre||Recruiting|
|Leiden, Zuid-Holland, Netherlands|
|Contact: Anne van Giezen, PhD +715273729 Giezen@fsw.leidenuniv.nl|
|Study Chair:||Philip Spinhoven, Prof. dr.||Leiden University, Institute for Psychological Research|
|Study Director:||Arnold A.P. van Emmerik, Dr.||Leiden University, Clinical Psychology Unit|
|Study Director:||Anne E. van Giezen, Dr.||Leiden University, Institute for Psychological Research, Clinical Psychology Unit|
|Study Chair:||Anne E.M. Speckens, Prof. dr.||Radboud University|
|Principal Investigator:||Suzanne de Klerk, MSc.||Leiden University, Institute for Psychological Research, Clinical Psychology Unit|