PsychosesNCT00260273
Access, Detection and Psychological Treatments
A study testing Cognitive Behaviour Therapy in people with Psychoses, run by Ontario Mental Health Foundation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Psychoses
- What is being tested?
- Cognitive Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12-30 years·
- Meeting criteria for an "at risk mental state" based on one or more of the 3 Criteria of Prodromal Symptoms (COPS criteria) with severity as determined by ratings on the Scale of Prodromal Symptoms (SOPS) or the criteria for attenuated symptoms of the early prodromal state defined by the presence of at least two of 9 symptoms on the Bonn Scale for the Assessment of Basic Symptoms that have been demonstrated to have the best positive predictive value of developing schizophrenia (Klosterkötter et al., 2001). These criteria for the early prodromal state course are currently used in the multi-site European Prediction of Psychosis Study (EPOS) (Birchwood et al., 2002).
Who cannot join
- Meets criteria for current or lifetime axis I psychotic disorder.·
- Meets DSM-IV criteria for an Axis 1 disorder where in the judgment of the evaluating clinician the diagnostic prodromal symptoms are clearly caused by the Axis 1 disorder. Note that, except for bipolar and psychotic disorders and a current major depression other DSM-IV disorders will not be exclusionary (e.g. substance abuse or dependence disorder, major depression, anxiety disorders, Axis II Disorders) as long as the disorder does not account for the diagnosis of prodromal symptoms.·
- Use of substances where in the judgment of the evaluating clinician, the diagnostic prodromal symptoms are substance-induced.
- Prior history of treatment with an antipsychotic for the current presenting symptoms or for any previous episode of psychotic symptoms.
- Impaired intellectual functioning (IQ< than 70).
- Past or current history of a clinically significant central nervous system disorder which may confound or contribute to prodromal symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 (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?
- Conditions
- Psychoses
- Being tested
- Cognitive Behaviour Therapy
- Keywords
- Preventive Therapy, Psychoses, Cognitive Behaviour Therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TherapyBehavioural
therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cognitive Behavioural Therapy Receives: Behavioral: Cognitive Behaviour Therapy |
| 2 | No intervention | supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion.
Measured: 18 months
Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview
Measured: 18 months
Research Stream 3: Costs of Caring in Psychosis Primary outcome measure: (i) Time to conversion, (ii) costs of formal and informal care giving.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startAug 2004
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Mental Health Foundation
- Sponsor type
- Other government
- Investigators
- Jean Addington, PhD, Principal investigator, Centre for Addiction and Mental Health/ University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260273
- Sponsor's protocol ID
- 107/2004
- Status last verified
- Oct 2007
- First submitted
- 28 Nov 2005
- Last updated
- 8 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access, Detection and Psychological Treatments
- ClinicalTrials.gov ID
- NCT00260273
- Acronym / sponsor ID
- 107/2004
- Conditions
- Psychoses
- Keywords
- Preventive Therapy, Psychoses, Cognitive Behaviour Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ontario Mental Health FoundationOther government
- Study start
- Aug 2004
- Study completion
- Aug 2008 (estimated)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Cognitive Behaviour Therapycognitive Behavioural Therapy |
| 2 | No intervention | –supportive therapy |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 12-30 years·
- Meeting criteria for an "at risk mental state" based on one or more of the 3 Criteria of Prodromal Symptoms (COPS criteria) with severity as determined by ratings on the Scale of Prodromal Symptoms (SOPS) or the criteria for attenuated symptoms of the early prodromal state defined by the presence of at least two of 9 symptoms on the Bonn Scale for the Assessment of Basic Symptoms that have been demonstrated to have the best positive predictive value of developing schizophrenia (Klosterkötter et al., 2001). These criteria for the early prodromal state course are currently used in the multi-site European Prediction of Psychosis Study (EPOS) (Birchwood et al., 2002).
Key exclusion criteria (6 listed)
- Meets criteria for current or lifetime axis I psychotic disorder.·
- Meets DSM-IV criteria for an Axis 1 disorder where in the judgment of the evaluating clinician the diagnostic prodromal symptoms are clearly caused by the Axis 1 disorder. Note that, except for bipolar and psychotic disorders and a current major depression other DSM-IV disorders will not be exclusionary (e.g. substance abuse or dependence disorder, major depression, anxiety disorders, Axis II Disorders) as long as the disorder does not account for the diagnosis of prodromal symptoms.·
- Use of substances where in the judgment of the evaluating clinician, the diagnostic prodromal symptoms are substance-induced.
- Prior history of treatment with an antipsychotic for the current presenting symptoms or for any previous episode of psychotic symptoms.
- Impaired intellectual functioning (IQ< than 70).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behaviour Therapytherapy | Behavioural | 1 |
Primary outcome
Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion.
Time frame: 18 months
Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview
Time frame: 18 months
Research Stream 3: Costs of Caring in Psychosis Primary outcome measure: (i) Time to conversion, (ii) costs of formal and informal care giving.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Addington, PhD principal investigator
Centre for Addiction and Mental Health/ University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy in people with Psychoses, run by Ontario Mental Health Foundation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion. (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2007.