Self-Injurious Behavior Clinical Trial
Official title:
The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm
Background:
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.
Objective:
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.
Design:
Multi-center randomized controlled clinical trial with repeated measurements at baseline
(M0),and posttreatment (M6)), 12 (M12) and 18 months (M18) after baseline.
Procedure:
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.
Interventions:
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.
Outcome measures:
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.
Economic evaluation:
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).
Data-analysis/power:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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