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A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00722163
Acronym
PSTEP
Enrollment
330
Registered
2008-07-25
Start date
2007-09-30
Completion date
2013-03-31
Last updated
2008-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis

Keywords

Cognitive Behavioural therapy, Psychosis

Brief 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. 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.

Interventions

OTHERCognitive Behavioural Therapy

Sponsors

Schizophrenia Society of Ontario
CollaboratorOTHER
Ontario Mental Health Foundation
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

1. stabilized outpatients, 2. ages 16 to 35 3. 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. 4. are competent and willing to give consent 5. are within 12 months of admission to the FEPP for a FE. Exclusion: 1. serious risk of suicide or violence to others 2. a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition.

Design outcomes

Primary

MeasureTime frame
Social Functioning18 months
Positive & negative symptoms18 months
Individual dimensions of psychotic symptoms18 months
Depression18 months
Substance use18 months
Alcohol and Drug Use18 months
Medication adherenceAdaptation to illness18 months
Self Esteem18 months
Coping Skills (MACS)18 months

Countries

Canada

Contacts

Primary ContactDiane Kirsopp, BA
diane_kirsopp@camh.net416-535-8501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026