Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00169884 |
| Other study ID # |
2100.0068 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
September 13, 2005 |
| Last updated |
January 31, 2006 |
| Start date |
March 2002 |
| Est. completion date |
March 2007 |
Study information
| Verified date |
January 2005 |
| Source |
Leiden University Medical Center |
| Contact |
Nadja Slee |
| Email |
nadja.slee[@]fsw.leidenuniv.nl |
| Is FDA regulated |
No |
| Health authority |
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate whether the proposed cognitive-behavioural
intervention is effective for DSH patients in the age group 15-35 years. In addition, we
will examine which elements derived from the theoretical model can explain the efficacy of
the intervention.
Description:
1. The development of treatment interventions for non-fatal deliberate self-harm (DSH)
among young people has received little attention in scientific literature and in mental
health care. This is surprising, considering the relatively high rates of
hospital-referred DSH among adolescents reported in epidemiological studies (Arensman
et al., 1995; Hawton et al., 1997; Hawton et al., 1998; Schmidtke et al., 1996). On the
basis of a four-year monitoring study (1989-1992) in the area of Leiden, the average
rate of DSH among females aged 15-24 was 179 per 100,000 and for males in this age
group the average rate was 91 per 100,000 (Arensman et al., 1995). General population
surveys among adolescents show a self-reported life-time prevalence of 2 to 5 percent
(Kienhorst et al., 1990; De Wilde et al., 2000). Reports from other European countries
indicate an increase of DSH in adolescents and young adults (15-30 years), in
particular in young males (Hawton et al., 1997; Schmidtke et al., 1996).
DSH is operationalized as dysfunctional behaviour associated with a heterogeneity of
psychological or psychiatric disorders e.g., affective disorders, anxiety disorders,
substance abuse, and eating disorders (Arensman & Kerkhof, 1996; Arensman, 1997; Ellis
et al., 1996; Engstroem et al., 1996; Kienhorst et al., 1993). However, a common
finding is that depressive symptoms (observer- or self-rated) and major depression
appear to be highly prevalent among young DSH patients (Burgess et al., 1998; Goldston
et al., 1998; Harrington et al., 1994). In these studies, co-morbidity with other types
of psychopathology also appeared to be relatively high.
The risk of repeated DSH is highest in the first year following an episode of DSH. The
repetition rates among young DSH patients vary from 10% (Goldacre & Hawton, 1985) to
27% (Arensman, 1997) in hospital referred DSH patients. Among DSH patients, prevention
of the first subsequent repeated episode of DSH is important in order to prevent a
pattern of chronic repetition.
Research findings with regard to risk factors associated with repeated DSH are fairly
consistent. Among young DSH patients, those with an increased risk for repeated DSH are
characterised by suicidal ideation, depression (Harrington et al., 2000; Hawton et al.,
1999), hopelessness (Brent, 1987; Hawton et al., 1999), impulsivity (Kashden et al.,
1993), disturbance of autobiographical memory (Evans et al., 1992), problems with peers
or other relationships, frequent or chronic stress and problem-solving deficits (De
Wilde et al., 2000; Hawton et al., in press; Rudd et al., 1998).
Despite the fact that many studies report these correlates, the available treatment
studies, which merely comprise evaluations of general treatment interventions, often
without a randomised controlled design, have not incorporated knowledge about risk
factors (Hawton et al., 1998). In addition, existing explanatory and treatment models
do not address the heterogeneity of the group of DSH patients. This is surprising,
considering the variety of characteristics and problems of DSH patients. So far, most
models focus on single psychiatric problems, such as depression or anxiety disorders.
The aim of this study is to present and test a therapeutic approach for DSH that goes
beyond single psychiatric diagnoses and that addresses the heterogeneity of DSH
patients. It will combine elements from cognitive-behavioural therapy, problem-solving
interventions and Dialectical Behaviour Therapy (DBT), since these approaches fit in
with the needs of different DSH patients. Patients in which depressive thoughts and
beliefs predominate may especially profit from the elements from cognitive therapy,
while patients who primarily experience problems in regulating their emotions may
especially profit from the elements from DBT. Patients in whom skills deficits
predominate may especially profit from the elements from problem solving interventions.
In addition to this combined treatment approach, attention will be given to specific
developmental issues that play a role among adolescent DSH patients. Furthermore,
knowledge of risk factors for (repetition of) DSH will be incorporated in the
treatment.
The model of the aetiology and maintenance of DSH on which the treatment protocol is
based addresses interactions between cognitive, affective, behavioural and
interpersonal aspects of DSH. As in other stress-process models, the relationship
between vulnerability factors (negative family experiences and biological
characteristics), triggering factors, and DSH is mediated by moderating variables
(interpersonal problems/lack of social support and individual characteristics:
cognitive distortions, affective dysregulation and skills deficits) and mediating
variables (negative appraisal, inadequate coping and psychological reactions such as
impulsivity). In accordance with Van Praag (1996), we assume that if a person with a
marginally functioning serotonergic-system experiences a stressful event he or she is
not able to cope with, the production of the stress-hormone cortisol increases, which
decreases the level of serotonin. Reduced serotonin activity in the prefrontal cortex
as examined by neuroimaging techniques, may be involved in the destabilisation of the
regulation of fear, aggression (Van Praag, 1996) and impulsivity (Mann, 1999), since
this area of the brain mediates behavioural inhibition. Increased impulsivity may
therefore increase the risk of DSH (Van Heeringen, 2001). We assume that in some
patients impulsivity and carelessness will be the primary features associated with DSH.
In particular, if impulsivity and feelings of hopelessness co-occur, the risk of DSH
appears to be high. The recognition of the association between hopelessness and DSH,
described here, is in line with the cognitive approach of Williams (2002) stating that
over time, among people who perceive they cannot change the stressful situation they
are in, despair gradually gains the upper hand and they will show more marked symptoms
of depression and hopelessness in particular.The approach as outlined by us, will have
advantages compared to approaches based on single psychiatric problems, since it
combines the main biological, cognitive, affective, behavioural and interpersonal
aspects of DSH.
2. The wide range of problems faced by young people who harm themselves calls for a
variety of different treatment strategies, varying from intensive care for those at
very high risk of suicide, to brief interventions for the group of patients in whom DSH
appears to have been a transient response to temporary difficulties and who have few
other problems (Harrington, 2001). One of the most important obstacles to treating DSH
patients that may play a role in almost every treatment is compliance (Heard, 2000 in:
Hawton and Van Heeringen). Another obstacle in treating DSH patients is the limited
availability of research data on effectiveness of therapy for DSH, especially of
randomised controlled trials. In the section that follows the most common treatment
approaches for DSH will be discussed. Attention will be given to what is known about
the effectiveness in terms of reduction of repeated episodes of DSH. Cognitive therapy
for DSH patients generally focuses on their tendency to evaluate events and the
presence and the future in such a way that this results in the feeling of being
entrapped (because of difficulties in coping) and hopelessness (because they have great
difficulty in generating positive future events) (Heard, 2000 in: Hawton and van
Heeringen). Cognitive and cognitive behavioural therapies directed at cognitive
restructuring seem to be promising in successfully treating patients who harm
themselves deliberately (Hawton et al., 1998).Given that problem-solving deficits
appear to be related to increased risk of self-harm (Orbach et al., 1990), the most
commonly used technique for older adolescents is brief problem oriented counselling,
which is a form of cognitive therapy. While problem-solving therapy seems to be
promising to improve depression, hopelessness and problem-solving skills (Towsend et
al., 2001), it is still unclear whether problem-solving therapy can help not only
address current problems but also longstanding deficiencies in problem-solving skills.
Current research focuses almost exclusively on solving real or hypothetical problems in
relationships with other people, yet one of the major issues for suicidal patients is
how they can solve the problem of how to gain control over their feelings. Linehan
(1993a, 1993b) developed an intensive treatment programme for patients with borderline
personality disorder, called Dialectical Behaviour Therapy (DBT). This treatment method
focuses on teaching skills that will help people to regulate their emotions and that
stress the acceptance of pain and crisis. In a review by Heard (2000 in: Hawton and van
Heeringen), in general, a decrease in repeated DSH was found among patients in DBT
treatment. Group therapy seems to be promising as a treatment for adolescents who
repeatedly harm themselves. However, larger studies are required to assess more
accurately the efficacy of this intervention (Wood, Trainor, Rothwell, Moore,
Harrington, 2001). No consensus on how to treat DSH medically has been reached yet. As
for the psychological treatments, most studies on the efficacy on psychopharmacological
treatments are too small to detect significant effects. So far, it appears that the
most promising treatments are high doses of Serotonin Specific Reuptake Inhibitors
(SSRIs), and, in selected cases atypical neuroleptics. SSRIs are probably the first
line medical treatment (Kavoussi et al., 1994). Tricyclics do not seem to be effective
for child and adolescent depressions and are toxic in overdose (Harrington, 2001). In
conclusion, it can be said that there still remains considerable uncertainty about
which type of psychosocial and medical treatments of DSH patients is most effective,
inclusion of insufficient numbers of patients in trials being the main limiting factor.
However, cognitive-behavioural therapies and problem-solving therapies and DBT seem to
be promising. The present study will incorporate elements from cognitive-behavioural
therapy, problem-solving interventions and DBT.
3. Study design. The subjects will be randomly allocated to the cognitive-behavioural
intervention (experimental group) and routine aftercare (control group), stratified
with respect to repetition of DSH and gender.The study subjects are patients aged 15-35
who are referred to the Leiden University Medical Center, to MCH Westeinde (The Hague),
or to local centers mental healthcare in Leiden (Rivierduinen)and The Hague (Parnassia
PMC), following an act of DSH. DSH patients will be included if they recently have been
engaged in an act of DSH including overdoses 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 behaviour, that without intervention
from others will cause self-harm, or deliberately ingests a substance in excess of the
prescribed or generally recognised dosage, and which is aimed at realising changes that
the person desires via the actual or expected physical consequences" (Platt et al.,
1992). DSH patients with severe psychiatric disorders requiring intensive long-term
psychiatric treatment will be excluded.
