Recruiting
Early Phase 1

Individual Therapy

Sponsor:

Ontario Mental Health Foundation

Code:

NCT00722163

Conditions

Psychosis

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioural Therapy

befriending

Study Details

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.

Conditions

Psychosis

Study ID

NCT00722163

Start date

Sep, 2007

Status verified date

Jul, 2008

Completion date

Mar, 2013

Anticipated

Primary completion date

May, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

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

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Arms

experimental: 1

behavioural

active comparator: 2

befriending

no intervention: 3

TAU

Interventions

Cognitive Behavioural Therapy

befriending

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M5T 1R8

Principal Investigator:

Jean Addington, PHD

More Information

Sponsor

Ontario Mental Health Foundation

Last update posted

Jul 25, 2008

Last verified

Jul, 2008

Keywords

  • Cognitive Behavioural therapy
  • Psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Mental Health Foundation on 2008-07-25.