Access, Detection and Psychological Treatments
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|ClinicalTrials.gov Identifier: NCT00260273|
Recruitment Status : Unknown
Verified October 2007 by Ontario Mental Health Foundation.
Recruitment status was: Active, not recruiting
First Posted : December 1, 2005
Last Update Posted : November 8, 2007
|First Submitted Date ICMJE||November 28, 2005|
|First Posted Date ICMJE||December 1, 2005|
|Last Update Posted Date||November 8, 2007|
|Study Start Date ICMJE||August 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00260273 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Access, Detection and Psychological Treatments|
|Official Title ICMJE||Access, Detection and Psychological Treatments|
|Brief Summary||Schizophrenia is one of society's 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 field's 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.|
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 (i.e., 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 (e.g., beliefs about and experiences with the medical system), structure (e.g., size, amount of support) and function (e.g., advice, support or coercion) have a critical influence on the pathways to mental health care for youth at ultra high risk for psychosis.(ii) 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 psychosis.(iii) 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 psychosis.(iv) The content, structure and function (e.g. 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 (i.e., service system and family caregivers, respectively).
(ii) What are other psychological costs of caring that informal caregivers face? (i.e. modification in parental work schedules to accommodate their child's needs, impact on other siblings) (iii) Over time, how do the costs of caring change in terms of the economic and psychological costs?
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Intervention ICMJE||Behavioral: Cognitive Behaviour Therapy
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Estimated Study Completion Date||August 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||12 Years to 30 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00260273|
|Other Study ID Numbers ICMJE||107/2004|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Ontario Mental Health Foundation|
|Collaborators ICMJE||Not Provided|
|PRS Account||Ontario Mental Health Foundation|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP