A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

Psychosis Clinical Trial

— PSTEP  

Official title:

A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00722163
• Other study ID #: 195/2006
• Status: Recruiting
• Phase: Phase 0
• First received: July 23, 2008
• Last updated: July 23, 2008
• Start date: September 2007
• Est. completion date: March 2013

Study information

• Verified date: July 2008
• Source: Ontario Mental Health Foundation
• Contact: Diane Kirsopp, BA
• Phone: 416-535-8501
• Email: diane_kirsopp[@]camh.net
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

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.

Other known NCT identifiers

• NCT00495911

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2013
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• Cognitive Behavioural Therapy

• befriending

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Mental Health Foundation	Schizophrenia Society of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Functioning		18 months	No
Primary	Positive & negative symptoms		18 months	No
Primary	Individual dimensions of psychotic symptoms		18 months	No
Primary	Depression		18 months	No
Primary	Substance use		18 months	No
Primary	Alcohol and Drug Use		18 months	No
Primary	Medication adherenceAdaptation to illness		18 months	No
Primary	Self Esteem		18 months	No
Primary	Coping Skills (MACS)		18 months	No