NCT02430935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

April 8, 2015

Last Update Submit

July 19, 2018

Conditions

Psychosis

Keywords

PsychosisPsychosis NOSSchizophreniaSchizoaffective DisorderEarly Intervention

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Cognitive Adaptation Training

EXPERIMENTAL

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.

Behavioral: Cognitive Adaptation Training

Action Based Cognitive Remediation

ACTIVE COMPARATOR

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.

Behavioral: Action Based Cognitive Remediation

Interventions

Cognitive Adaptation TrainingBEHAVIORAL

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).

Cognitive Adaptation Training
Action Based Cognitive RemediationBEHAVIORAL

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.

Action Based Cognitive Remediation

Eligibility Criteria

Age16 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • not currently experiencing high level of paranoia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

Related 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. No abstract available.

    PMID: 2602512BACKGROUND

  • 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.

    PMID: 18889466BACKGROUND

  • 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.

    PMID: 2289094BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 19521972BACKGROUND

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

    PMID: 14588938BACKGROUND

  • 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.

    PMID: 24893903BACKGROUND

  • 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.

    PMID: 24794880BACKGROUND

  • 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.

    PMID: 690089BACKGROUND

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

    BACKGROUND

  • 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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 7956112BACKGROUND

Related Links

MeSH Terms

Conditions

Psychotic DisordersMental DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Sean Kidd

    Clinician Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 30, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

CA(1)