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

Self-Injurious Behavior Clinical Trial

— DSH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00694668
• Other study ID #: 120610008
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 5, 2008
• Last updated: November 5, 2009
• Start date: May 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2009
• Source: Leiden University Medical Center
• Contact: Suzanne de Klerk, MSc.
• Phone: 31-71-527-3995
• Email: SKlerk[@]fsw.leidenuniv.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Recently engaged in an act of DSH including overdose of medication, ingestion of chemical substances and self-inflicted injuries according to the definition which is used in the WHO/Euro Multicentre Study on parasuicide:"An act with non-fatal outcome in which an individual deliberately initiates a non-habitual behavior, that without intervention from other will cause self-harm, or deliberately ingests a substance in excess of the prescribed or generally recognized dosage, and which is aimed at realizing changes that the person desires via the actual or expected physical consequences"(Platt et al., 1992).

• Aged between 15 and 35

• Living in the region of Leiden or Nijmegen

Exclusion Criteria:

• Severe psychiatric disorder or substance abuse requiring intensive inpatient treatment

• Serious cognitive impairments

• Not be able to converse in Dutch

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Self-Injurious Behavior

Intervention

Behavioral:
• Cognitive Behavioral treatment
Brief cognitive behavioral therapy (12 sessions)
• Mindfulness based cognitive therapy
9 sessions MBCT in a group-format (up to 8 persons)

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden	Zuid-Holland
Netherlands	Rivierduinen Mental Health Centre	Leiden	Zuid-Holland
Netherlands	University Medical Centre St. Radboud	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	University Medical Centre Nijmegen(departement of psychiatry), ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		M0, M6, M12, M18	No
Secondary	depression, as measured by the Beck depression Inventory II		M0, M6, M12, M18	No
Secondary	Anxiety, as measured by the symptom checklist '90		M0, M6, M12, M18	No
Secondary	Hostility, as measured by the symptom checklist '90		M0, M6, M12, M18	No
Secondary	Self-concept, as measured by the Robson self-concept questionnaire		M0, M6, M12, M18	No
Secondary	Suicidal cognitions, as measured by the suicidal cognitions scale		M0, M6, M12, M18	No
Secondary	QALYs, assessed by the EQ5D		M0, M6, M12, M18	No
Secondary	COSTS, assessed by a 6-monthly diary		M0 - M6, M6 - M12, M12 - M18	No
Secondary	Problem-solving skills, as measured by the Means Ends Problem-Solving Test		M0, M6	No
Secondary	Experimental avoidance, as measured by the Acceptance and Action Questionnaire		M0, M6	No
Secondary	difficulties in emotion-regulation, as measured by the difficulties in emotion regulation scale		M0, M6	No
Secondary	general tendency to ruminate, as measured by the Ruminative Response Scale		M0, M6	No
Secondary	mindfulness skills, as measured by the Five Facet Mindfulness Questionnaire		M0, M6	No
Secondary	pathological dissociation, as measured by the dissociative experiences scale - taxon		M0, M6	No
Secondary	Autobiographical memory, assessed by the autobiographical memory task		M0, M6	No
Secondary	worrying, as measured by the Penn State Worry Questionnaire		M0 M6	No