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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 psychiatr

Detailed Summary:
Sponsor: Leiden University Medical Center

Current Primary Outcome: 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 ]

Original Primary Outcome: Repetition of DSH [ Time Frame: M0, M6, M12, M18 ]

Current Secondary Outcome:

  • depression, as measured by the Beck depression Inventory II [ Time Frame: M0, M6, M12, M18 ]
  • Anxiety, as measured by the symptom checklist '90 [ Time Frame: M0, M6, M12, M18 ]
  • Hostility, as measured by the symptom checklist '90 [ Time Frame: M0, M6, M12, M18 ]
  • Self-concept, as measured by the Robson self-concept questionnaire [ Time Frame: M0, M6, M12, M18 ]
  • Suicidal cognitions, as measured by the suicidal cognitions scale [ Time Frame: M0, M6, M12, M18 ]
  • QALYs, assessed by the EQ5D [ Time Frame: M0, M6, M12, M18 ]
  • COSTS, assessed by a 6-monthly diary [ Time Frame: M0 - M6, M6 - M12, M12 - M18 ]
  • Problem-solving skills, as measured by the Means Ends Problem-Solving Test [ Time Frame: M0, M6 ]
  • Experimental avoidance, as measured by the Acceptance and Action Questionnaire [ Time Frame: M0, M6 ]
  • difficulties in emotion-regulation, as measured by the difficulties in emotion regulation scale [ Time Frame: M0, M6 ]
  • general tendency to ruminate, as measured by the Ruminative Response Scale [ Time Frame: M0, M6 ]
  • mindfulness skills, as measured by the Five Facet Mindfulness Questionnaire [ Time Frame: M0, M6 ]
  • pathological dissociation, as measured by the dissociative experiences scale - taxon [ Time Frame: M0, M6 ]
  • Autobiographical memory, assessed by the autobiographical memory task [ Time Frame: M0, M6 ]
  • worrying, as measured by the Penn State Worry Questionnaire [ Time Frame: M0 M6 ]


Original Secondary Outcome:

  • depression [ Time Frame: M0, M6, M12, M18 ]
  • Anxiety [ Time Frame: M0, M6, M12, M18 ]
  • Hostility [ Time Frame: M0, M6, M12, M18 ]
  • Self-concept [ Time Frame: M0, M6, M12, M18 ]
  • Suicidal cognitions [ Time Frame: M0, M6, M12, M18 ]
  • QALYs [ Time Frame: M0, M6, M12, M18 ]
  • COSTS [ Time Frame: M0, M6, M12, M18 ]
  • Problem-solving skills [ Time Frame: M0, M6 ]
  • experimental avoidance [ Time Frame: M0, M6 ]
  • difficulties in emotion-regulation [ Time Frame: M0, M6 ]
  • general tendency to ruminate [ Time Frame: M0, M6 ]
  • mindfulness skills [ Time Frame: M0, M6 ]
  • pathological dissociation [ Time Frame: M0, M6 ]
  • Autobiographical memory [ Time Frame: M0, M6 ]


Information By: Leiden University Medical Center

Dates:
Date Received: June 5, 2008
Date Started: May 2008
Date Completion: October 2012
Last Updated: November 5, 2009
Last Verified: November 2009