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

NCT00694668 | Unknown Phase 2

• 1 other identifier: 120610008
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Deliberate Self-Harm; Self-Injurious Behaviour; Suicidal Behaviour; Cognitive behavioural therapy; Mindfulness Based cognitive therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• depression, as measured by the Beck depression Inventory II

  M0, M6, M12, M18

• Anxiety, as measured by the symptom checklist '90

  M0, M6, M12, M18

• Hostility, as measured by the symptom checklist '90

  M0, M6, M12, M18

• Self-concept, as measured by the Robson self-concept questionnaire

  M0, M6, M12, M18

• Suicidal cognitions, as measured by the suicidal cognitions scale

  M0, M6, M12, M18

Study Arms (2)

1

EXPERIMENTAL

Cognitive Behavioural Treatment

Behavioral: Cognitive Behavioral treatment

2

EXPERIMENTAL

Mindfulness Based Cognitive Therapy-training

Behavioral: Mindfulness based cognitive therapy

Interventions

Cognitive Behavioral treatment BEHAVIORAL

Brief cognitive behavioral therapy (12 sessions)

1

Mindfulness based cognitive therapy BEHAVIORAL

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

2

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Severe psychiatric disorder or substance abuse requiring intensive inpatient treatment
• Serious cognitive impairments
• Not be able to converse in Dutch

Sponsors & Collaborators

• Leiden University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• University Medical Centre Nijmegen(departement of psychiatry): collaborator

Study Sites (3)

University Medical Centre St. Radboud

Nijmegen, Gelderland, Netherlands

RECRUITING

Leiden University Medical Centre

Leiden, South Holland, Netherlands

RECRUITING

Rivierduinen Mental Health Centre

Leiden, South Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Philip Spinhoven, Prof. dr.

  Leiden University, Institute for Psychological Research

  STUDY CHAIR

• 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 DIRECTOR

• Anne E.M. Speckens, Prof. dr.

  Radboud University Medical Center

  STUDY CHAIR

• Suzanne de Klerk, MSc.

  Leiden University, Institute for Psychological Research, Clinical Psychology Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne de Klerk, MSc.

CONTACT

31-71-527-3995; SKlerk@fsw.leidenuniv.nl

Anne van Giezen, Dr.

CONTACT

31-71-527-3729; Giezen@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 10, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: October 1, 2012
• Last Updated: November 6, 2009

Record last verified: 2009-11

Locations

NL (3)