PsychosisEarly Phase 1PSTEPNCT00722163
A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
A Early Phase 1 study testing Cognitive Behavioural Therapy and befriending in people with Psychosis, run by Ontario Mental Health Foundation at 1 site in Canada.
Trial summary
In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to medication regimes and more than 60% have intermittent periods of gaps of non-adherence. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive Behavioural Therapy and befriending
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Mar 2013
- Phase
- Early Phase 1
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- stabilized outpatients,
- ages 16 to 35
- meet DSM-IV criteria for: schizophrenia, schizophreniform disorder, brief psychotic disorder, delusional disorder, schizoaffective disorder, substance induced psychotic disorder, or psychotic disorder NOS. Participants who also meet DSM-IV criteria for substance abuse or dependence will not be excluded.
- are competent and willing to give consent
- are within 12 months of admission to the FEPP for a FE.
Who cannot join
- serious risk of suicide or violence to others
- a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
Jean Addington, PHD
About this study
In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to medication regimes and more than 60% have intermittent periods of gaps of non-adherence. Relapse rates are high with 82% of patients relapsing at least once within 5 years. Unfortunately even amongst those who do achieve full remission from psychotic symptoms, functional recovery remains a major challenge for patients. All the evidence suggests that individuals with SCZ do best with a combination of pharmacology and psychosocial intervention. Cognitive-behavior therapy (CBT) is gaining recognition as an effective treatment in SCZ and is in fact the only psychosocial treatment in SCZ with proven durability at short term follow-up. Although it is currently being used, the investigators need to learn more about the impact of CBT on FE SCZ especially as experts are advocating for CBT to be a critical component of FE clinical services.
Read the detailed description
The primary problem to be addressed is the incomplete functional recovery following a FE of SCZ and whether CBT is an effective treatment to aid this recovery. If CBT were to positively impact recovery in the FE we then need to address (i) which mechanisms are responsible for this improvement, and (ii) whether this treatment is effective for all FE patients.
- Conditions
- Psychosis
- Being tested
- Cognitive Behavioural Therapy, befriending
- Keywords
- Cognitive Behavioural therapy, Psychosis
- 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 Behavioural TherapyOther
befriendingOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | behavioural Receives: Other: Cognitive Behavioural Therapy |
| 2 | Active comparator | befriending Receives: Other: befriending |
| 3 | No intervention | TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning
Measured: 18 months
Positive & negative symptoms
Measured: 18 months
Individual dimensions of psychotic symptoms
Measured: 18 months
Depression
Measured: 18 months
Substance use
Measured: 18 months
Alcohol and Drug Use
Measured: 18 months
Medication adherenceAdaptation to illness
Measured: 18 months
Self Esteem
Measured: 18 months
Coping Skills (MACS)
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 posted25 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2009 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Mental Health Foundation
- Sponsor type
- Other government
- Collaborators
- Schizophrenia Society of Ontario
- Investigators
- Jean Addington, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722163
- Sponsor's protocol ID
- 195/2006
- Acronym
- PSTEP
- Status last verified
- Jul 2008
- First submitted
- 23 Jul 2008
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
- ClinicalTrials.gov ID
- NCT00722163
- Acronym / sponsor ID
- PSTEP / 195/2006
- Conditions
- Psychosis
- Keywords
- Cognitive Behavioural therapy, Psychosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Ontario Mental Health FoundationOther government
- Collaborators
- Schizophrenia Society of Ontario
- Study start
- Sep 2007
- Primary completion
- May 2009 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 25 Jul 2008 (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.
In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to medication regimes and more than 60% have intermittent periods of gaps of non-adherence. Relapse rates are high with 82% of patients relapsing at least once within 5 years. Unfortunately even amongst those who do achieve full remission from psychotic symptoms, functional recovery remains a major challenge for patients. All the evidence suggests that individuals with SCZ do best with a combination of pharmacology and psychosocial intervention. Cognitive-behavior therapy (CBT) is gaining recognition as an effective treatment in SCZ and is in fact the only psychosocial treatment in SCZ with proven durability at short term follow-up. Although it is currently being used, the investigators need to learn more about the impact of CBT on FE SCZ especially as experts are advocating for CBT to be a critical component of FE clinical services.
Detailed description
The primary problem to be addressed is the incomplete functional recovery following a FE of SCZ and whether CBT is an effective treatment to aid this recovery. If CBT were to positively impact recovery in the FE we then need to address (i) which mechanisms are responsible for this improvement, and (ii) whether this treatment is effective for all FE patients.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Cognitive Behavioural Therapybehavioural |
| 2 | Active comparator | Other: befriendingbefriending |
| 3 | No intervention | –TAU |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- stabilized outpatients,
- ages 16 to 35
- meet DSM-IV criteria for: schizophrenia, schizophreniform disorder, brief psychotic disorder, delusional disorder, schizoaffective disorder, substance induced psychotic disorder, or psychotic disorder NOS. Participants who also meet DSM-IV criteria for substance abuse or dependence will not be excluded.
- are competent and willing to give consent
- are within 12 months of admission to the FEPP for a FE.
Key exclusion criteria (2 listed)
- serious risk of suicide or violence to others
- a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition.
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 Behavioural Therapy | Other | 1 |
| befriending | Other | 2 |
Primary outcome
Social Functioning
Time frame: 18 months
Positive & negative symptoms
Time frame: 18 months
Individual dimensions of psychotic symptoms
Time frame: 18 months
Depression
Time frame: 18 months
Substance use
Time frame: 18 months
Alcohol and Drug Use
Time frame: 18 months
Medication adherenceAdaptation to illness
Time frame: 18 months
Self Esteem
Time frame: 18 months
Coping Skills (MACS)
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 25 Jul 2008.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Behavioural Therapy and befriending in people with Psychosis, 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 5 inclusion and 2 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 25 Jul 2008. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Diane Kirsopp, BA (416-535-8501 ext. 6288, diane_kirsopp@camh.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning (time frame: 18 months). The study lists 9 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 25 Jul 2008.