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

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430935
• Other study ID #: 03/24/2015
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Cognitive Adaptation Training
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).
• Action Based Cognitive Remediation
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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View 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. — View Citation

BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. — View 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. — View Citation

Delis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.

Diagnostic and statistical manual of mental disorders (4th ed.). American Psychiatric Association, Washington, DC

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. — View Citation

Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44. — View 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. — View 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. — View 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. — View Citation

The Psychological Corporation. (1997). WAIS-III administration and scoring manual. San Antonio, TX: Psychological Corporation.

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

Wilkinson ,G. (1993). Wide Range Achievement Test 3 (Manual). Wilmington, DE: Wide Range Inc.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from baseline to 4 months and 9 months
Primary	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 from baseline to 4 months and 9 months
Primary	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.	Change from baseline to 4 months and 9 months
Secondary	Medication Adherence	Medication adherence will be determined through regular pill counts of currently prescribed psychiatric medications and pharmacy records.	Throughout the 9 months of participation.
Secondary	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.	Throughout the 9 months of participation.
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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 from baseline to 4 months and 9 months
Secondary	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.	Change from baseline to 4 months and 9 months

External Links

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