Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169884
Status:
UNKNOWN
Last Update Posted:
2006-02-01
First Post:
2005-09-13
Brief Title:
The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients A Randomized Controlled Trial Among Adolescents and Young Adults
Status:
UNKNOWN
Status Verified Date:
2005-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 100000 and for males in this age group the average rate was 91 per 100000 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 eg 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 problemslack 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 particularThe 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 1998Given 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 genderThe 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 Rivierduinenand 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 WHOEuro 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
DSH is operationalized as dysfunctional behaviour associated with a heterogeneity of psychological or psychiatric disorders eg 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 problemslack 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 particularThe 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 1998Given 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 genderThe 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 Rivierduinenand 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 WHOEuro 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None