Clinical trial NCT04294719: A Study of Cognitive Adaptation Training in Inpatient Forensic Environments
Official title: A Study of Cognitive Adaptation Training in Inpatient Forensic Environments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognitive Adaptation Training
Forensic
Inpatient
Cognition
Environmental Supports
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be recruited through CAMH Complex Care \& Recovery inpatient forensic services.

Brief summary: The proposed project will be a mixed-methods feasibility study of modified Cognitive Adaptation Training for an inpatient forensic mental health population (finCAT). Cognitive Adaptation Training (CAT) is an evidence-based compensatory cognitive intervention that focuses on improving functioning through the provision of environmental supports and cues. CAT is typically applied in outpatient care but has been successfully modified for inpatient service contexts in a Netherlands trial and at CAMH in previous pilots for both forensic and non-forensic inpatient populations.

Detailed description: The proposed project will expand the investigators knowledge of the role of compensatory cognitive interventions for forensic inpatient populations with schizophrenia. Over the course of 6 months, the investigators will conduct a feasibility study of the delivery of a modified forensic inpatient version of Cognitive Adaptation Training. The objective of this single group study with pre-post and follow up assessments is to determine if preliminary outcomes and follow up findings support the feasibility of a modified version CAT within a forensic inpatient setting. Feasibility data will be used to inform (i) any necessary adjustments to the intervention, (ii) any necessary adjustments to the optimal time of study for outcomes to be observed, and (iii) to inform future trials with respect to anticipated recruitment and drop-out rates and optimal powering.

This study would be among the few examinations of CAT as an inpatient intervention to date, as well as the first to examine a modified cognitive adaptation training approach in both a North American and forensic inpatient setting, and would make a substantial contribution to the evidence-based intervention literature. This intervention will be referred to as forensic inpatient CAT or finCAT.

The questions for this project are:

1. Is finCAT feasible for forensic inpatient populations with a schizophrenia spectrum diagnosis? Based on preliminary work the investigators hypothesize that finCAT will prove acceptable to patients and inpatient staff and will demonstrate positive outcomes with respect to functioning and inpatient room organization.
2. What are the attitudes of inpatient forensic occupational therapists and clinical teams towards implementing finCAT on their units?

This study will expand on the preliminary work of the investigators at CAMH. The study will be implemented on four CAMH general security forensic inpatient units. There will be four weeks of CAT Clinician--delivered treatment focusing on two goal areas - room organization and personal hygiene, followed by two months of maintenance by CAT Unit Champions with pre, post, and two-month follow-up, as well as project-end evaluations. In the first four weeks, the investigators will conduct a trial of finCAT for two of the four inpatient general forensic units, followed by two months of finCAT maintenance with Unit CAT Champions supported by the CAT Clinician. This process would then be repeated on the remaining two general units at CAMH. Previous implementation of CAT has demonstrated gains within one-month; however, follow-up assessments were not conducted to determine if gains were maintained over time. While brief, this time period (i) reflects the intent of this study as a pilot test of feasibility and, (ii) aligns with this circumscribed version of CAT (as compared to the more comprehensive community version with broader outcome domains). Data will be collected from both primary participants (inpatients) and the clinical team.

Eligibility criteria: Inclusion Criteria:

1. A chart diagnosis of a schizophrenia spectrum illness.
2. Capacity to consent or availability of a substitute decision-maker to consent with the assent of the participant.
3. Participant residing on a CAMH inpatient forensic unit (general security)

Exclusion Criteria

1. High paranoia
2. Primary issue of hoarding

Primary outcomes:
measure: Clutter Image Rating Scale (CIRS) - Blind-rated
timeFrame: Baseline
measure: Clutter Image Rating Scale (CIRS) - Blind-rated
timeFrame: 4-Weeks Post-Intervention
measure: Clutter Image Rating Scale (CIRS) - Blind-rated
timeFrame: 2-Month Follow-Up
measure: Clutter Image Rating Scale (CIRS) - Patient-rated
timeFrame: Baseline
measure: Clutter Image Rating Scale (CIRS) - Patient-rated
timeFrame: 4-Weeks Post-Intervention
measure: Life Skills Profile (LSP) - Self-Care Subscale
timeFrame: Baseline
measure: Life Skills Profile (LSP) - Self-care Subscale
timeFrame: 4-Weeks Post-Intervention
measure: Life Skills Profile (LSP) - Self-care Subscale
timeFrame: 2-Month Follow-Up
measure: Goal Attainment Scaling (GAS) - Goal 1
timeFrame: Baseline
measure: Goal Attainment Scaling (GAS) - Goal 1
timeFrame: 4-Week Post-Intervention
measure: Goal Attainment Scaling (GAS) - Goal 1
timeFrame: 2-Month Follow-Up
measure: Goal Attainment Scaling (GAS) - Goal 2
timeFrame: Baseline
measure: Goal Attainment Scaling (GAS) - Goal 2
timeFrame: 4-Week Post-Intervention
measure: Goal Attainment Scaling (GAS) - Goal 2
timeFrame: 2-Month Follow-Up
Secondary outcomes:
measure: Evidence-Based Practice Attitude Scale (EBPAS)
timeFrame: Baseline
measure: Evidence-Based Practice Attitude Scale (EBPAS)
timeFrame: 2-Month Follow-Up
measure: Essen Climate Evaluation Schema (Essen CES)
timeFrame: Baseline
measure: Essen Climate Evaluation Schema (Essen CES)
timeFrame: 2-Month Follow-Up
measure: Qualitative Care Provider Attitudes
timeFrame: 2 months after month of service implementation
measure: Qualitative Participant Attitudes
timeFrame: 2 months after month of service implementation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Sean Kidd
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004 Jun;6(2):61-74. doi: 10.1023/b:mhsr.0000024351.12294.65.
citation: Brown S, Inskip H, Barraclough B. Causes of the excess mortality of schizophrenia. Br J Psychiatry. 2000 Sep;177:212-7. doi: 10.1192/bjp.177.3.212.
citation: Chen S, Collins A, Anderson K, McKenzie K, Kidd S. Patient Characteristics, Length of Stay, and Functional Improvement for Schizophrenia Spectrum Disorders: A Population Study of Inpatient Care in Ontario 2005 to 2015. Can J Psychiatry. 2017 Dec;62(12):854-863. doi: 10.1177/0706743716680167. Epub 2016 Dec 14.
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.
citation: Frost, R. O., Steketee, G., Tolin, D. F., & Renaud, S. (2008). Development and validation of the clutter image rating. Journal of Psychopathology and Behavioral Assessment, 30(3), 193-203.
citation: Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.
citation: Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
citation: Harvey, P. D. (Ed.). (2013). Cognitive impairment in schizophrenia: Characteristics, assessment and treatment. Cambridge University Press.
citation: Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
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.
citation: Maples, N. J., & Velligan, D. I. (2008). Cognitive adaptation training: establishing environmental supports to bypass cognitive deficits and improve functional outcomes. American Journal of Psychiatric Rehabilitation, 11(2), 164-180.
citation: Rosen A, Hadzi-Pavlovic D, Parker G. The life skills profile: a measure assessing function and disability in schizophrenia. Schizophr Bull. 1989;15(2):325-37. doi: 10.1093/schbul/15.2.325.
citation: Schalast N, Redies M, Collins M, Stacey J, Howells K. EssenCES, a short questionnaire for assessing the social climate of forensic psychiatric wards. Crim Behav Ment Health. 2008;18(1):49-58. doi: 10.1002/cbm.677.
citation: Stiekema AP, Quee PJ, Dethmers M, van den Heuvel ER, Redmeijer JE, Rietberg K, Stant AD, Swart M, van Weeghel J, Aleman A, Velligan DI, Schoevers RA, Bruggeman R, van der Meer L. Effectiveness and cost-effectiveness of cognitive adaptation training as a nursing intervention in long-term residential patients with severe mental illness: study protocol for a randomized controlled trial. Trials. 2015 Feb 12;16:49. doi: 10.1186/s13063-015-0566-8.
citation: Torrey WC, Drake RE, Dixon L, Burns BJ, Flynn L, Rush AJ, Clark RE, Klatzker D. Implementing evidence-based practices for persons with severe mental illnesses. Psychiatr Serv. 2001 Jan;52(1):45-50. doi: 10.1176/appi.ps.52.1.45.
citation: van Dam, M., Stiekema, A., Islam, A., Swart, M., Redmeyer, J., Dethmers, M., ... & Bruggeman, R. (2017). SU15. Implementation of Cognitive Adaptation Training in a Hospital Setting: Facilitating and Hampering Factors. Schizophrenia bulletin, 43(Suppl 1), S166.
citation: van der Meer, L., Stiekema, A., van Dam, M., Swart, M., Redmeyer, J., Dethmers, M., ... & Pijnenborg, G. M. (2017). SU13. Cognitive Adaptation Training: Is It Effective as a Nursing Intervention in a Hospital Setting?. Schizophrenia bulletin, 43(Suppl 1), S165.
citation: Velligan, D. I., Mahurin, R. K., Eckert, S. L., Miller, A. L., & Bow-Thomas, C. C. (1997). Cognitive adaptation training: The use of compensatory strategies for inpatients and outpatients with schizophrenia. Schizophrenia Research, 1(24), 229.
citation: Velligan DI, Bow-Thomas CC, Huntzinger C, Ritch J, Ledbetter N, Prihoda TJ, Miller AL. Randomized controlled trial of the use of compensatory strategies to enhance adaptive functioning in outpatients with schizophrenia. Am J Psychiatry. 2000 Aug;157(8):1317-23. doi: 10.1176/appi.ajp.157.8.1317.
citation: Velligan DI, Prihoda TJ, Ritch JL, Maples N, Bow-Thomas CC, Dassori A. A randomized single-blind pilot study of compensatory strategies in schizophrenia outpatients. Schizophr Bull. 2002;28(2):283-92. doi: 10.1093/oxfordjournals.schbul.a006938.
citation: Velligan DI, Lam F, Ereshefsky L, Miller AL. Psychopharmacology: Perspectives on medication adherence and atypical antipsychotic medications. Psychiatr Serv. 2003 May;54(5):665-7. doi: 10.1176/appi.ps.54.5.665. No abstract available.
citation: Velligan DI, Diamond PM, Mintz J, Maples N, Li X, Zeber J, Ereshefsky L, Lam YW, Castillo D, Miller AL. The use of individually tailored environmental supports to improve medication adherence and outcomes in schizophrenia. Schizophr Bull. 2008 May;34(3):483-93. doi: 10.1093/schbul/sbm111. Epub 2007 Oct 10.
citation: Velligan DI, Diamond PM, Maples NJ, Mintz J, Li X, Glahn DC, Miller AL. Comparing the efficacy of interventions that use environmental supports to improve outcomes in patients with schizophrenia. Schizophr Res. 2008 Jul;102(1-3):312-9. doi: 10.1016/j.schres.2008.02.005. Epub 2008 Apr 18.
citation: Williams, R.S. (June 2017). Occupational Therapists' Perspectives on Cognitive Adaptation Training. Poster presented at the Canadian Association of Occupational Therapists Conference, Charlottetown, PE, Canada.