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Clinical Trials/NCT02430935
NCT02430935
Completed
Not Applicable

A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis

Centre for Addiction and Mental Health1 site in 1 country67 target enrollmentApril 2015
ConditionsPsychosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychosis
Sponsor
Centre for Addiction and Mental Health
Enrollment
67
Locations
1
Primary Endpoint
Change in Adaptive Functioning (SOFAS)
Status
Completed
Last Updated
7 years ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sean Kidd

Clinician Scientist

Centre for Addiction and Mental Health

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.

Outcomes

Primary Outcomes

Change in Adaptive Functioning (SOFAS)

Time Frame: Change from baseline to 4 months and 9 months

A global level of social and occupational functioning will be obtained using the Social and Occupational Functioning Scale from the DSM-IV (American Psychiatric Association, 2000). The SOFAS rates global functioning on a scale from 0 to 100. The rating does not take into account level of symptomatology.

Change in Adaptive Functioning (SFS)

Time Frame: Change from baseline to 4 months and 9 months

The Social Functioning Scale (SFS; Birchwood et al., 1990) will be administered. This is a self-report measure that details the frequency and intensity with which the person engages in functional activities. A total score and domain scores for social withdrawal, relationships, social activity, recreational activity, independence (competence), independence (performance) and employment are generated.

change in Adaptive Functioning (MCAS)

Time Frame: Change from baseline to 4 months and 9 months

Both client and clinician versions of 17-item The Multnomah Community Ability Scale (MCAS, Barker et al., 1994) will be used to assess functionality.

Secondary Outcomes

  • Medication Adherence(Throughout the 9 months of participation.)
  • Hospitalization(Throughout the 9 months of participation.)
  • Change in Goal Attainment (GAS)(Change from baseline to 4 months and 9 months)
  • Change in Caregiver Burden (IEQ)(Change from baseline to 4 months and 9 months)
  • Change in Cognition (WRAT-III)(Change from baseline to 4 months and 9 months)
  • Change in Cognition (Trail Making test part A)(Change from baseline to 4 months and 9 months)
  • Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )(Change from baseline to 4 months and 9 months)
  • Change in Cognition (CVLT)(Change from baseline to 4 months and 9 months)
  • Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)(Change from baseline to 4 months and 9 months)
  • Change in Positive symptoms (BPRS-E)(Change from baseline to 4 months and 9 months)
  • Change in Negative symptoms (NSA)(Change from baseline to 4 months and 9 months)

Study Sites (1)

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