Clinical trial NCT02430935: A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis
Official title: A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Psychosis
Psychosis NOS
Schizophrenia
Schizoaffective Disorder
Early Intervention
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 67
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied.

Detailed description: The proposed project will expand knowledge of the role of compensatory and restorative cognitive interventions for early intervention population individuals with schizophrenia. The investigators will conduct a two arm randomized trial comparing the impacts of CAT and Action Based Cognitive Remediation (ABCR) for individuals with schizophrenia who are under the age of 30. The model would mirror the investigators' preliminary work at CAMH (Kidd et al., 2014) in which there will be 4 months of specialist-delivered treatment followed by 5 months of maintenance by case managers with pre, 4 month, and 9 month evaluations conducted. This study will be among the most rigorous examinations of such interventions to date, would be among the first to examine integrative approaches, and would make a substantial contribution to the early intervention literature.

The questions for the purposes of this project are:

1. Is CAT effective among individuals with schizophrenia under the age of 30?

   and
2. Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT alone?

Eligibility criteria: Inclusion Criteria:

* Participants must be CAMH clients, have an assigned caseworker, be between the ages of 16-34 and have a psychosis such as schizophrenia or schizoaffective disorder.

Exclusion Criteria:

* not currently experiencing high level of paranoia.

Primary outcomes:
measure: Change in Adaptive Functioning (SOFAS)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Adaptive Functioning (SFS)
timeFrame: Change from baseline to 4 months and 9 months
measure: change in Adaptive Functioning (MCAS)
timeFrame: Change from baseline to 4 months and 9 months
Secondary outcomes:
measure: Medication Adherence
timeFrame: Throughout the 9 months of participation.
measure: Hospitalization
timeFrame: Throughout the 9 months of participation.
measure: Change in Goal Attainment (GAS)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Caregiver Burden (IEQ)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Cognition (WRAT-III)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Cognition (Trail Making test part A)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Cognition (CVLT)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Positive symptoms (BPRS-E)
timeFrame: Change from baseline to 4 months and 9 months
measure: Change in Negative symptoms (NSA)
timeFrame: Change from baseline to 4 months and 9 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Clinician Scientist
name: Sean Kidd
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kidd SA, Kaur J, Virdee G, George TP, McKenzie K, Herman Y. Cognitive remediation for individuals with psychosis in a supported education setting: a randomized controlled trial. Schizophr Res. 2014 Aug;157(1-3):90-8. doi: 10.1016/j.schres.2014.05.007. Epub 2014 Jun 2.
citation: Kidd SA, Herman Y, Barbic S, Ganguli R, George TP, Hassan S, McKenzie K, Maples N, Velligan D. Testing a modification of cognitive adaptation training: streamlining the model for broader implementation. Schizophr Res. 2014 Jun;156(1):46-50. doi: 10.1016/j.schres.2014.03.026. Epub 2014 Apr 29.
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