SchizophreniaNCT00239122
Recovery Therapy Trial
A study testing Recovery Therapy (Cognitive Behaviour Therapy for psychosis) in people with Schizophrenia and Psychotic Disorders, run by Melbourne Health at 2 sites in Australia.
Trial summary
This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders, Mood Disorders
- What is being tested?
- Recovery Therapy (Cognitive Behaviour Therapy for psychosis)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 94 participants
- Where
- 2 sitesAustralia
- Study dates
- Jun 2000to Feb 2004
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- acceptance by the participating Community Mental Health Services for case management
- a preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder
- a recovery "need" in one of the areas addressed by the therapy
Who cannot join
- a preliminary DSM-IV diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder, PTSD) even where psychotic features are/have been present
- non-English speaking
- comorbid intellectual disability
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Whittlesea Community Mental Health Service
Epping, Victoria, 3076
Darebin Community Mental Health Service
Preston, Victoria, 3072
About this study
Official title: Applicability of CBT to Unselected Mental Health Service Clients With Psychotic Disorders
This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders
- Being tested
- Recovery Therapy (Cognitive Behaviour Therapy for psychosis)
- Keywords
- Cognitive Therapy, Psychotic Disorders, Treatment Outcome
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Therapy (Cognitive Behaviour Therapy for psychosis)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services
Secondary outcomes (3)
To establish rates of uptake of Recovery Therapy amongst clients at a community mental health service
To establish effectiveness of therapy in clients who received a defined length of therapeutic contact (12-24 sessions)
To identify factors predicting uptake and effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startJun 2000
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- William Buckland Foundation
- Investigators
- John Farhall, BA(Hons), MA, Principal investigator, LaTrobe University, NorthWestern Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239122
- Sponsor's protocol ID
- E00013
- Status last verified
- Oct 2005
- First submitted
- 12 Oct 2005
- Last updated
- 14 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of CBT to Unselected Mental Health Service Clients With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT00239122
- Acronym / sponsor ID
- E00013
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders
- Keywords
- Cognitive Therapy, Psychotic Disorders, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- William Buckland Foundation
- Study start
- Jun 2000
- Study completion
- Feb 2004
- First posted
- 14 Oct 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.
This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- acceptance by the participating Community Mental Health Services for case management
- a preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder
- a recovery "need" in one of the areas addressed by the therapy
Key exclusion criteria (3 listed)
- a preliminary DSM-IV diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder, PTSD) even where psychotic features are/have been present
- non-English speaking
- comorbid intellectual disability
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 |
|---|---|---|
| Recovery Therapy (Cognitive Behaviour Therapy for psychosis) | Behavioural | – |
Primary outcome
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services
3 secondary outcomes
To establish rates of uptake of Recovery Therapy amongst clients at a community mental health service
To establish effectiveness of therapy in clients who received a defined length of therapeutic contact (12-24 sessions)
To identify factors predicting uptake and effectiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2005.
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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.
John Farhall, BA(Hons), MA principal investigator
LaTrobe University, NorthWestern Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Therapy (Cognitive Behaviour Therapy for psychosis) in people with Schizophrenia and Psychotic Disorders, run by Melbourne Health at 2 sites in Australia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services. 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 14 Oct 2005.