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

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Adaptation Training
Action Based Cognitive Remediation
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Early Intervention

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Adaptation Training

Action Based Cognitive Remediation

Arm Description

Cognitive Adaptation Training (CAT) is a standardized approach to the use of environmental supports for improving multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia.

ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.

Outcomes

Primary Outcome Measures

Change in Adaptive Functioning (SOFAS)
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)
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)
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 Outcome Measures

Medication Adherence
Medication adherence will be determined through regular pill counts of currently prescribed psychiatric medications and pharmacy records.
Hospitalization
Hospitalization will be tracked by (i) monitoring of electronic records through the central CAMH database and (ii) the reports of the primary Case Manager. Both frequency and duration of inpatient stays will be documented as will the frequency of emergency room visits.
Change in Goal Attainment (GAS)
Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals that has demonstrated good reliability and validity with severe mental illness populations (Hurn et al., 2006). Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Goals are individualized to the client and assessment of progress are determined through consensus of the clinician and case manager.
Change in Caregiver Burden (IEQ)
Caregiver burden will be measured for the family member involved in implementing CAT using the 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000). This questionnaire, which has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks.
Change in Cognition (WRAT-III)
The Wide Range Achievement Test (WRAT-III) reading subtest (Wilkinson, 1993) will be used to evaluate pre-morbid educational attainment.
Change in Cognition (Trail Making test part A)
The Trail Making test part A (Radford et al., 1978), a test involving using lines to connect numbers, will be used to assess scanning ability and psychomotor speed.
Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )
Short term memory will be evaluated with the digit span subtest of the Weschler Adult Intelligence Scale - III (The Psychological Corporation, 1997).
Change in Cognition (CVLT)
Verbal learning and memory will be assessed with the California Verbal Learning Test (CVLT -Delis et al., 1987). The CVLT involves the repeated presentation of a word list that determines acquisition ability and retention.
Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)
Executive functioning will be assessed with the Trail Making Test, Part B, and the Wisconsin Card Sorting Test (WCST - Berg, 1948).
Change in Positive symptoms (BPRS-E)
Positive symptoms will be assessed using the expanded version of the Brief Psychiatric Rating Scale (BPRS-E; Ventura et al., 1993). The BPRS-E is a 24-item scale assessing multiple domains of psychopathology on a series of 7-point scales (1-7). A positive symptom factor score is composed of items assessing hallucinations, unusual thought content, conceptual disorganization and suspiciousness.
Change in Negative symptoms (NSA)
Negative symptoms will be assessed using the Negative Symptom Assessment (NSA; Alphs et al., 1989). The NSA is a 26-item instrument examining negative symptomatology on a series of 7-point scales (0-6). A total negative symptom score is calculated by adding together the scores from the NSA subscales, communication, emotion, motivation, social functioning, and cognition.

Full Information

First Posted
April 8, 2015
Last Updated
July 19, 2018
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02430935
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Is CAT effective among individuals with schizophrenia under the age of 30? and Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT alone?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Early Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Adaptation Training
Arm Type
Experimental
Arm Description
Cognitive Adaptation Training (CAT) is a standardized approach to the use of environmental supports for improving multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia.
Arm Title
Action Based Cognitive Remediation
Arm Type
Active Comparator
Arm Description
ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Adaptation Training
Intervention Description
Cognitive Adaptation Training (CAT) is a manual-driven standardized approach that uses environmental supports to improve multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. Interventions for each functional deficit are based on two dimensions 1) level of impairment in executive functions (determined by neurocognitive tests) and 2) whether the overt behavior of the individual is characterized more by apathy (poverty of speech/movement/inability to initiate and follow through on behavioral sequences), disinhibition (distractibility/behavior which is highly cue-driven) or a combination of these styles (based on the Frontal Lobe Personality Scale (FLOPS).
Intervention Type
Behavioral
Intervention Name(s)
Action Based Cognitive Remediation
Intervention Description
ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.
Primary Outcome Measure Information:
Title
Change in Adaptive Functioning (SOFAS)
Description
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.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Adaptive Functioning (SFS)
Description
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.
Time Frame
Change from baseline to 4 months and 9 months
Title
change in Adaptive Functioning (MCAS)
Description
Both client and clinician versions of 17-item The Multnomah Community Ability Scale (MCAS, Barker et al., 1994) will be used to assess functionality.
Time Frame
Change from baseline to 4 months and 9 months
Secondary Outcome Measure Information:
Title
Medication Adherence
Description
Medication adherence will be determined through regular pill counts of currently prescribed psychiatric medications and pharmacy records.
Time Frame
Throughout the 9 months of participation.
Title
Hospitalization
Description
Hospitalization will be tracked by (i) monitoring of electronic records through the central CAMH database and (ii) the reports of the primary Case Manager. Both frequency and duration of inpatient stays will be documented as will the frequency of emergency room visits.
Time Frame
Throughout the 9 months of participation.
Title
Change in Goal Attainment (GAS)
Description
Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals that has demonstrated good reliability and validity with severe mental illness populations (Hurn et al., 2006). Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Goals are individualized to the client and assessment of progress are determined through consensus of the clinician and case manager.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Caregiver Burden (IEQ)
Description
Caregiver burden will be measured for the family member involved in implementing CAT using the 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000). This questionnaire, which has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Cognition (WRAT-III)
Description
The Wide Range Achievement Test (WRAT-III) reading subtest (Wilkinson, 1993) will be used to evaluate pre-morbid educational attainment.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Cognition (Trail Making test part A)
Description
The Trail Making test part A (Radford et al., 1978), a test involving using lines to connect numbers, will be used to assess scanning ability and psychomotor speed.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )
Description
Short term memory will be evaluated with the digit span subtest of the Weschler Adult Intelligence Scale - III (The Psychological Corporation, 1997).
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Cognition (CVLT)
Description
Verbal learning and memory will be assessed with the California Verbal Learning Test (CVLT -Delis et al., 1987). The CVLT involves the repeated presentation of a word list that determines acquisition ability and retention.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)
Description
Executive functioning will be assessed with the Trail Making Test, Part B, and the Wisconsin Card Sorting Test (WCST - Berg, 1948).
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Positive symptoms (BPRS-E)
Description
Positive symptoms will be assessed using the expanded version of the Brief Psychiatric Rating Scale (BPRS-E; Ventura et al., 1993). The BPRS-E is a 24-item scale assessing multiple domains of psychopathology on a series of 7-point scales (1-7). A positive symptom factor score is composed of items assessing hallucinations, unusual thought content, conceptual disorganization and suspiciousness.
Time Frame
Change from baseline to 4 months and 9 months
Title
Change in Negative symptoms (NSA)
Description
Negative symptoms will be assessed using the Negative Symptom Assessment (NSA; Alphs et al., 1989). The NSA is a 26-item instrument examining negative symptomatology on a series of 7-point scales (0-6). A total negative symptom score is calculated by adding together the scores from the NSA subscales, communication, emotion, motivation, social functioning, and cognition.
Time Frame
Change from baseline to 4 months and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Kidd
Organizational Affiliation
Clinician Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
2602512
Citation
Alphs LD, Summerfelt A, Lann H, Muller RJ. The negative symptom assessment: a new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull. 1989;25(2):159-63. No abstract available.
Results Reference
background
PubMed Identifier
18889466
Citation
BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. doi: 10.1080/00221309.1948.9918159. No abstract available.
Results Reference
background
PubMed Identifier
2289094
Citation
Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.
Results Reference
background
Citation
Delis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.
Results Reference
background
PubMed Identifier
19521972
Citation
Draper ML, Stutes DS, Maples NJ, Velligan DI. Cognitive adaptation training for outpatients with schizophrenia. J Clin Psychol. 2009 Aug;65(8):842-53. doi: 10.1002/jclp.20612.
Results Reference
background
PubMed Identifier
14588938
Citation
Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44.
Results Reference
background
PubMed Identifier
24893903
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.
Results Reference
background
PubMed Identifier
24794880
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.
Results Reference
background
PubMed Identifier
690089
Citation
Radford LM, Chaney EF, O'Leary MR, O'Leary DE. Screening for cognitive impairment among inpatients. J Clin Psychiatry. 1978 Sep;39(9):712-5.
Results Reference
background
Citation
The Psychological Corporation. (1997). WAIS-III administration and scoring manual. San Antonio, TX: Psychological Corporation.
Results Reference
background
Citation
Ventura J, Green MF, Shaner A, Liberman RP: Training and quality assurance with the brief psychiatric rating scale: The drift busters. International Journal of Methods in Psychiatric Research 1993; 3:221-24
Results Reference
background
Citation
Wilkinson ,G. (1993). Wide Range Achievement Test 3 (Manual). Wilmington, DE: Wide Range Inc.
Results Reference
background
Citation
Diagnostic and statistical manual of mental disorders (4th ed.). American Psychiatric Association, Washington, DC
Results Reference
background
PubMed Identifier
7956112
Citation
Barker S, Barron N, McFarland BH, Bigelow DA. A community ability scale for chronically mentally ill consumers: Part I. Reliability and validity. Community Ment Health J. 1994 Aug;30(4):363-83. doi: 10.1007/BF02207489.
Results Reference
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Links:
URL
http://www.camh.ca/en/research/Pages/research.aspx
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teaching hospital.

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

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