NCT00722163

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 25, 2008

Status Verified

July 1, 2008

Enrollment Period

1.7 years

First QC Date

July 23, 2008

Last Update Submit

July 23, 2008

Conditions

Psychosis

Keywords

Cognitive Behavioural therapyPsychosis

Outcome Measures

Primary Outcomes (9)

  • Social Functioning

    18 months

  • Positive & negative symptoms

    18 months

  • Individual dimensions of psychotic symptoms

    18 months

  • Depression

    18 months

  • Substance use

    18 months

  • Alcohol and Drug Use

    18 months

  • Medication adherenceAdaptation to illness

    18 months

  • Self Esteem

    18 months

  • Coping Skills (MACS)

    18 months

Study Arms (3)

1

EXPERIMENTAL

behavioural

Other: Cognitive Behavioural Therapy

2

ACTIVE COMPARATOR

befriending

Other: befriending

3

NO INTERVENTION

TAU

Interventions

Cognitive Behavioural TherapyOTHER
1
befriendingOTHER
2

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • serious risk of suicide or violence to others
  • a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jean Addington, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Kirsopp, BA

CONTACT

416-535-8501diane_kirsopp@camh.net

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

September 1, 2007

Primary Completion

May 1, 2009

Study Completion

March 1, 2013

Last Updated

July 25, 2008

Record last verified: 2008-07

Locations

CA(1)