Self-Injurious BehaviorPhase 2/3DSHNCT00694668
The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm
A Phase 2/3 study testing Cognitive Behavioral treatment and Mindfulness based cognitive therapy in people with Self-Injurious Behavior, run by Leiden University Medical Center at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Self-Injurious Behavior
- What is being tested?
- Cognitive Behavioral treatment and Mindfulness based cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesNetherlands
- Study dates
- May 2008to Oct 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Severe psychiatric disorder or substance abuse requiring intensive inpatient treatment
- Serious cognitive impairments
- Not be able to converse in Dutch
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland
Anne van Giezen, PhD, +31-71-527-3729, Giezen@fsw.leidenuniv.nl
- Recruiting
Rivierduinen Mental Health Centre
Leiden, South Holland
Anne van Giezen, PhD, +715273729, Giezen@fsw.leidenuniv.nl
- Recruiting
University Medical Centre St. Radboud
Nijmegen, Gelderland
Speckens, Prof. dr., a.speckens@psy.umcn.nl
de Klerk, MSc, S.deklerk@psy.umcn.nl
About this study
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.
Read more
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
- Being tested
- Cognitive Behavioral treatment, Mindfulness based cognitive therapy
- Keywords
- Deliberate Self-Harm, Self-Injurious Behaviour, Suicidal Behaviour, Cognitive behavioural therapy, Mindfulness Based cognitive therapy
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral treatmentBehavioural
Brief cognitive behavioral therapy (12 sessions)
Mindfulness based cognitive therapyBehavioural
9 sessions MBCT in a group-format (up to 8 persons)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive Behavioural Treatment Receives: Behavioral: Cognitive Behavioral treatment |
| 2 | Experimental | Mindfulness Based Cognitive Therapy-training Receives: Behavioral: Mindfulness based cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: M0, M6, M12, M18
Secondary outcomes (15)
depression, as measured by the Beck depression Inventory II
Measured: M0, M6, M12, M18
Anxiety, as measured by the symptom checklist '90
Measured: M0, M6, M12, M18
Hostility, as measured by the symptom checklist '90
Measured: M0, M6, M12, M18
Self-concept, as measured by the Robson self-concept questionnaire
Measured: M0, M6, M12, M18
Suicidal cognitions, as measured by the suicidal cognitions scale
Measured: M0, M6, M12, M18
QALYs, assessed by the EQ5D
Measured: M0, M6, M12, M18
COSTS, assessed by a 6-monthly diary
Measured: M0 - M6, M6 - M12, M12 - M18
Problem-solving skills, as measured by the Means Ends Problem-Solving Test
Measured: M0, M6
Experimental avoidance, as measured by the Acceptance and Action Questionnaire
Measured: M0, M6
difficulties in emotion-regulation, as measured by the difficulties in emotion regulation scale
Measured: M0, M6
general tendency to ruminate, as measured by the Ruminative Response Scale
Measured: M0, M6
mindfulness skills, as measured by the Five Facet Mindfulness Questionnaire
Measured: M0, M6
pathological dissociation, as measured by the dissociative experiences scale - taxon
Measured: M0, M6
Autobiographical memory, assessed by the autobiographical memory task
Measured: M0, M6
worrying, as measured by the Penn State Worry Questionnaire
Measured: M0 M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2010 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, University Medical Centre Nijmegen(departement of psychiatry)
- Investigators
- Philip Spinhoven, Prof. dr., Study chair, Leiden University, Institute for Psychological ResearchArnold A.P. van Emmerik, Dr., Study director, Leiden University, Clinical Psychology UnitAnne E. van Giezen, Dr., Study director, Leiden University, Institute for Psychological Research, Clinical Psychology UnitAnne E.M. Speckens, Prof. dr., Study chair, Radboud University Medical CenterSuzanne de Klerk, MSc., Principal investigator, Leiden University, Institute for Psychological Research, Clinical Psychology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694668
- Sponsor's protocol ID
- 120610008
- Acronym
- DSH
- Status last verified
- Nov 2009
- First submitted
- 5 Jun 2008
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm
- ClinicalTrials.gov ID
- NCT00694668
- Acronym / sponsor ID
- DSH / 120610008
- Conditions
- Self-Injurious Behavior
- Keywords
- Deliberate Self-Harm, Self-Injurious Behaviour, Suicidal Behaviour, Cognitive behavioural therapy, Mindfulness Based cognitive therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, University Medical Centre Nijmegen(departement of psychiatry)
- Study start
- May 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral treatmentCognitive Behavioural Treatment |
| 2 | Experimental | Behavioral: Mindfulness based cognitive therapyMindfulness Based Cognitive Therapy-training |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Severe psychiatric disorder or substance abuse requiring intensive inpatient treatment
- Serious cognitive impairments
- Not be able to converse in Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral treatmentBrief cognitive behavioral therapy (12 sessions) | Behavioural | 1 |
| Mindfulness based cognitive therapy9 sessions MBCT in a group-format (up to 8 persons) | Behavioural | 2 |
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
15 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Spinhoven, Prof. dr. study chair
Leiden University, Institute for Psychological Research
Arnold A.P. van Emmerik, Dr. study director
Leiden University, Clinical Psychology Unit
Anne E. van Giezen, Dr. study director
Leiden University, Institute for Psychological Research, Clinical Psychology Unit
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Behavioral treatment and Mindfulness based cognitive therapy in people with Self-Injurious Behavior, run by Leiden University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne de Klerk, MSc. (31-71-527-3995, SKlerk@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2009.