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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Leiden University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
University Medical Centre Nijmegen(departement of psychiatry)
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00694668
First received: June 5, 2008
Last updated: November 5, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Self-Injurious Behavior
Behavioral: Cognitive Behavioral treatment
Behavioral: Mindfulness based cognitive therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: M0, M6, M12, M18 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 84
Study Start Date: May 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive Behavioural Treatment
Behavioral: Cognitive Behavioral treatment
Brief cognitive behavioral therapy (12 sessions)
Experimental: 2
Mindfulness Based Cognitive Therapy-training
Behavioral: Mindfulness based cognitive therapy
9 sessions MBCT in a group-format (up to 8 persons)

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694668

Contacts
Contact: Suzanne de Klerk, MSc. 31-71-527-3995 SKlerk@fsw.leidenuniv.nl
Contact: Anne van Giezen, Dr. 31-71-527-3729 Giezen@fsw.leidenuniv.nl

Locations
Netherlands
University Medical Centre St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Speckens, Prof. dr.       a.speckens@psy.umcn.nl   
Contact: de Klerk, MSc       S.deklerk@psy.umcn.nl   
Leiden University Medical Centre Recruiting
Leiden, Zuid-Holland, Netherlands
Contact: Anne van Giezen, PhD    +31-71-527-3729    Giezen@fsw.leidenuniv.nl   
Rivierduinen Mental Health Centre Recruiting
Leiden, Zuid-Holland, Netherlands
Contact: Anne van Giezen, PhD    +715273729    Giezen@fsw.leidenuniv.nl   
Sponsors and Collaborators
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
University Medical Centre Nijmegen(departement of psychiatry)
Investigators
Study Chair: Philip Spinhoven, Prof. dr. Leiden University, Institute for Psychological Research
Study Director: 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 Chair: Anne E.M. Speckens, Prof. dr. Radboud University
Principal Investigator: Suzanne de Klerk, MSc. Leiden University, Institute for Psychological Research, Clinical Psychology Unit
  More Information

No publications provided

Responsible Party: Anne van Giezen, PhD, Leiden University
ClinicalTrials.gov Identifier: NCT00694668     History of Changes
Other Study ID Numbers: 120610008
Study First Received: June 5, 2008
Last Updated: November 5, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Leiden University Medical Center:
Deliberate Self-Harm
Self-Injurious Behaviour
Suicidal Behaviour
Cognitive behavioural therapy
Mindfulness Based cognitive therapy

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 19, 2014