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.
ID
Source
Brief title
Condition
- Suicidal and self-injurious behaviours NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As in the previous study patients are asked for the exact number of episodes of
DSH during the past 3 months using a semi-structured interview.
Secondary outcome
Also the same secondary outcome measures as in he previous study will be used (
depression (BDI-II), anxiety (SCL-90), self-concept (RSC-Q), and suicide
cognitions (SCS)). 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). Also, problems in emotion regulation will be assessed
before and after treatment (AMT and DERS).
Background summary
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 programmes 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 (ZonMw project Program Prevention/Innovation
projectnr. 21000068) also showed positive effects on repetition of DSH and
associated problems.
Study 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.
Study design
Multi-center randomized controlled clinical trial with repeated measurements at
baseline (M0), and posttreatment (M6)), 12 (M12) and 18 months (M18) after
baseline.
Intervention
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.
Study burden and risks
From a previous study we learned that of the approximately 80 persons with DSH
referred to both participating centres each year about 50% is traceable,
eligible and willing to participate. Following the two additional treatments
(MBCT (20 hours of treatment) or CBT (12 hours of treatment)) involves no
special risks. Study participants will be assessed with self-report
questionnaires and semi-structured interviews at four time points during a
period of 18 months (total testing time 6-8 hours). In a previous study using a
similar assessment strategy, this frequency and intensity of measurements
proved to be feasible.
Suicidal risk and crises of study participants is monitored by the main
therapist. In cases where research assistants discover serious suicidal risk
the research assistant will directly contact the main therapist after
discussing this with the study participant involved. When there is no main
therapist (as can be the case in the TAU condition) study participants will be
directly referred to the emergency department of the medical hospital or mental
health institution for a psychiatric consultation and crisis interventions will
be arranged.
P.O. Box 9555
2300 RB Leiden
NL
P.O. Box 9555
2300 RB Leiden
NL
Listed location countries
Age
Inclusion criteria
Adolescents and young adults aged 15-35 years who recently engaged in self-harming behaviour, regardless of the intent (e.g. trying to hurt or kill oneself), will be included after referral to the Leiden University Medical Center, Rivierduinen or the University Medical Centre St. Radboud following their act of DSH .
Exclusion criteria
Persons (a) reporting severe psychiatric disorders requiring intensive inpatient treatment (such as schizophrenia or problems with alcohol and drugs), (b) unable to converse in Dutch, (c) manifesting serious cognitive impairments, or (d) living outside the region of Leiden or Nijmegen will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18117.058.07 |