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A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis

NCT ID: NCT00722163

Last Updated: 2008-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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

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Psychosis

Keywords

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Cognitive Behavioural therapy Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

behavioural

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type OTHER

2

befriending

Group Type ACTIVE_COMPARATOR

befriending

Intervention Type OTHER

3

TAU

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioural Therapy

Intervention Type OTHER

befriending

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schizophrenia Society of Ontario

OTHER

Sponsor Role collaborator

Ontario Mental Health Foundation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Centre for Addiction and Mental Health

Principal Investigators

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Jean Addington, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Diane Kirsopp, BA

Role: CONTACT

Phone: 416-535-8501

Email: [email protected]

Other Identifiers

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195/2006

Identifier Type: -

Identifier Source: org_study_id

NCT00495911

Identifier Type: -

Identifier Source: nct_alias