Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260273
Status:
UNKNOWN
Last Update Posted:
2007-11-08
First Post:
2005-11-28
Brief Title:
Access Detection and Psychological Treatments
Sponsor:
Ontario Mental Health Foundation
Organization:
Ontario Mental Health Foundation
Study Overview
Official Title:
Access Detection and Psychological Treatments
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_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:
Schizophrenia is one of societys most costly medical conditions and the most severe among psychiatric disorders One of the most important and exciting new concepts in psychiatry is that detection and intervention very early in the course of schizophrenia offers what may be the fields best practical hope for realizing substantive improvements in the outcome of schizophrenia or schizophrenia spectrum disorders Thus we propose a five year program that focuses on three interconnected major research streams 1 an evaluation of the effectiveness and cost-effectiveness of a model-driven psychological intervention in preventing or delaying the onset of a psychotic illness 2 a qualitative study of the pathways to mental health at this time of very high risk and 3 an exploration of the burden to the healthcare and informal caregiver systems associated with this high risk population
Detailed Description:
Research Stream 1
Treatment and Cost Effectiveness The primary aim of Stream 1 is to evaluate the effectiveness of a model-driven psychological intervention CBT in preventing or delaying the onset of a psychotic illness and to evaluate the effectiveness of CBT in reducing presenting concerns in a sample of help-seeking individuals who have been operationally defined to be at ultra high risk of developing a psychotic illness CBT will be compared to supportive therapy ST We will also examine the cost-effectiveness of a preventive approach Using a cost-consequence approach we will examine the cost-effectiveness of CBT versus supportive therapy in addressing psychosis in the ultra high risk phase from the perspective of the payer ie the Ministry of Health and Long-Term Care The hypotheses are
i The time of conversion will be significantly longer for those in the CBT group compared to those in the ST condition
ii The mean level of attenuated psychotic symptoms SOPS ratings will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point
iii Levels of risk factors measured by CMRS GHQ2 will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point
iv Levels of depression and anxiety measured by CDSS BAS SPAI2 will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point
v Level of social functioning measured by SFS2 will be significantly higher in the CBT group compared to the ST group at the termination of the trial and at each follow up point
vi CBT will be more cost-effective than ST
Research Stream 2
Pathways to Care The aim of stream 2 is to obtain the in-depth stories of the ways in which those at ultra high risk of developing a psychotic illness come to seek help from mental health services By mental health services we include the formal system specialty mental health general medical care lay system friends family self-help folk system alternative healers and human social service system clergy teachers police These will be sought from both the perspective of youth and from the perspective of their significant others Multiple case studies using qualitative approaches will focus on the following four elements 1 social content 2 social support system 3 the illness career and 4 the treatment system See Appendix A for detailed components within these elements of the model These case studies will be employed to further empirically develop theory relating to pathways to mental health care Theoretical Propositions The following four theoretical propositions related to pathways to mental health care were formulated based on the Network Episode Model described above The focus of this stream will be upon the evaluation refinement and elaboration of these four theoretical propositions Multiple case study methodology will be employed to further empirically develop theory relating to pathways to mental health care i Family content eg beliefs about and experiences with the medical system structure eg size amount of support and function eg advice support or coercion have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosisii The community and school content structure and function have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosisiii Problem recognition and the illness experience as perceived by the individual and significant others have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosisiv The content structure and function eg organizational constraints of the treatment system have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosis
Research Stream 3
Costs of Caring in Psychosis The aim of this third research stream is to explore the burden to the healthcare system and informal caregivers associated with this ultra high risk population We seek to address three primary questions
i What are the key components affecting the costs of caring for the ultra high risk population These costs will be considered with respect to both the formal and informal care providers ie service system and family caregivers respectively
ii What are other psychological costs of caring that informal caregivers face ie modification in parental work schedules to accommodate their childs needs impact on other siblings iii Over time how do the costs of caring change in terms of the economic and psychological costs
Treatment and Cost Effectiveness The primary aim of Stream 1 is to evaluate the effectiveness of a model-driven psychological intervention CBT in preventing or delaying the onset of a psychotic illness and to evaluate the effectiveness of CBT in reducing presenting concerns in a sample of help-seeking individuals who have been operationally defined to be at ultra high risk of developing a psychotic illness CBT will be compared to supportive therapy ST We will also examine the cost-effectiveness of a preventive approach Using a cost-consequence approach we will examine the cost-effectiveness of CBT versus supportive therapy in addressing psychosis in the ultra high risk phase from the perspective of the payer ie the Ministry of Health and Long-Term Care The hypotheses are
i The time of conversion will be significantly longer for those in the CBT group compared to those in the ST condition
ii The mean level of attenuated psychotic symptoms SOPS ratings will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point
iii Levels of risk factors measured by CMRS GHQ2 will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point
iv Levels of depression and anxiety measured by CDSS BAS SPAI2 will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point
v Level of social functioning measured by SFS2 will be significantly higher in the CBT group compared to the ST group at the termination of the trial and at each follow up point
vi CBT will be more cost-effective than ST
Research Stream 2
Pathways to Care The aim of stream 2 is to obtain the in-depth stories of the ways in which those at ultra high risk of developing a psychotic illness come to seek help from mental health services By mental health services we include the formal system specialty mental health general medical care lay system friends family self-help folk system alternative healers and human social service system clergy teachers police These will be sought from both the perspective of youth and from the perspective of their significant others Multiple case studies using qualitative approaches will focus on the following four elements 1 social content 2 social support system 3 the illness career and 4 the treatment system See Appendix A for detailed components within these elements of the model These case studies will be employed to further empirically develop theory relating to pathways to mental health care Theoretical Propositions The following four theoretical propositions related to pathways to mental health care were formulated based on the Network Episode Model described above The focus of this stream will be upon the evaluation refinement and elaboration of these four theoretical propositions Multiple case study methodology will be employed to further empirically develop theory relating to pathways to mental health care i Family content eg beliefs about and experiences with the medical system structure eg size amount of support and function eg advice support or coercion have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosisii The community and school content structure and function have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosisiii Problem recognition and the illness experience as perceived by the individual and significant others have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosisiv The content structure and function eg organizational constraints of the treatment system have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosis
Research Stream 3
Costs of Caring in Psychosis The aim of this third research stream is to explore the burden to the healthcare system and informal caregivers associated with this ultra high risk population We seek to address three primary questions
i What are the key components affecting the costs of caring for the ultra high risk population These costs will be considered with respect to both the formal and informal care providers ie service system and family caregivers respectively
ii What are other psychological costs of caring that informal caregivers face ie modification in parental work schedules to accommodate their childs needs impact on other siblings iii Over time how do the costs of caring change in terms of the economic and psychological costs
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