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The (cost-)effectiveness of mindfulness training and cognitive-behavioral treatment in adolescents and young adults with deliberate self-harm

Projectomschrijving

De afgelopen jaren laat een sterke toename zien in de frequentie waarmee jongeren zichzelf beschadigen. Vroege identificatie en behandeling van personen met zelfbeschadigend gedrag is van belang omdat iedere episode van zelfbeschadigend gedrag het risico op toekomstige episodes doet toenemen en uiteindelijk ook het risico op suïcide. Er is een aantal behandelingsprogramma’s voor zelfbeschadiging ontwikkeld, waarvan is aangetoond dat ze effectief zijn in het reduceren van zelfbeschadiging bij volwassenen. Met name het verbeteren van inadequate emotieregulatiestrategieën lijkt essentieel bij het voorkomen van toekomstige episodes van zelfbeschadiging. In dit project werd het effect op zelfbeschadiging en emotiehantering van een individuele cognitieve-gedragstherapie voor jongeren tussen 15 en 35 jaar vergeleken met het effect van een groepstraining in mindfulness ofwel aandachttraining. Vanwege een tegenvallende instroom is het project vroegtijdig stopgezet. Het is niet mogelijk om een uitspraak te doen of het effect van mindfulness based cognitive therapy (MBCT) in een groep vergelijkbaar is met de reeds bewezen effectiviteit van individuele cognitieve gedragstherapie (CGT). 

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Samenvatting van de aanvraag

-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 programmes 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 (ZonMw project Program Prevention/Innovation projectnr. 21000068) 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 he 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. -Time schedule: M 1-3 preparations, M 4- 28 screening and treatment, M 10 – 34 posttest, M 16 -40 follow-up 6 months, M 22 -46 follow-up 12 months, M 28 – 48 analyses, interpretation, preparation of publications.

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Kenmerken

Projectnummer:
120610008
Looptijd: 100%
Looptijd: 100 %
2008
2011
Onderdeel van programma:
Projectleider en penvoerder:
Prof. dr. P.H. Spinhoven
Verantwoordelijke organisatie:
Universiteit Leiden