The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm

Summary

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.

Conditions

• Self-Injurious Behavior

Interventions

BEHAVIORAL

Cognitive Behavioral treatment

Brief cognitive behavioral therapy (12 sessions)

BEHAVIORAL

Mindfulness based cognitive therapy

9 sessions MBCT in a group-format (up to 8 persons)

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• University Medical Centre Nijmegen(departement of psychiatry)

  collaborator UNKNOWN

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Philip Spinhoven, Prof. dr. · Leiden University, Institute for Psychological Research

• Arnold A.P. van Emmerik, Dr. · Leiden University, Clinical Psychology Unit

• Anne E. van Giezen, Dr. · Leiden University, Institute for Psychological Research, Clinical Psychology Unit

• Anne E.M. Speckens, Prof. dr. · Radboud University Medical Center

• Suzanne de Klerk, MSc. · Leiden University, Institute for Psychological Research, Clinical Psychology Unit

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2010-11-30

Completion

2012-10-31

Countries

• Netherlands

Study Locations