NCT04294719

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

December 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

February 11, 2020

Results QC Date

April 21, 2022

Last Update Submit

April 21, 2022

Conditions

Keywords

SchizophreniaCognitive Adaptation TrainingForensicInpatientCognitionEnvironmental Supports

Outcome Measures

Primary Outcomes (14)

  • Clutter Image Rating Scale (CIRS) - Blind-rated

    Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.

    Baseline

  • Clutter Image Rating Scale (CIRS) - Blind-rated

    Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.

    4-Weeks Post-Intervention

  • Clutter Image Rating Scale (CIRS) - Blind-rated

    Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.

    2-Month Follow-Up

  • Clutter Image Rating Scale (CIRS) - Patient-rated

    Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.

    Baseline

  • Clutter Image Rating Scale (CIRS) - Patient-rated

    Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.

    4-Weeks Post-Intervention

  • Life Skills Profile (LSP) - Self-Care Subscale

    Personal hygiene will be measured by scores on the Life Skills Profile (LSP; Rosen, Hadzi-Pavlovic, \& Parker, 1989). The LSP consists of 39 clinician-rated questions on a four-point scale and measures various aspects related to daily life activities: self-care; non-turbulence; social contact; communication; responsibility. For this project, only the self-care ratings from the full LSP-39 will be completed by service providers (items 10, 12, 13, 14, 15, 16, 23, 24, 26, and 30). While each item consists of 4 responses, the content of each response is different for each item. Overall, higher scores indicate better functioning. Max total score is 40. Min total score is 10. Current inpatient research on the use of CAT also uses this scale as a primary measure of the effectiveness of CAT. Scores will be obtained from the nursing staff not directly involved in the delivery of the finCAT intervention.

    Baseline

  • Life Skills Profile (LSP) - Self-care Subscale

    Personal hygiene will be measured by scores on the Life Skills Profile (LSP; Rosen, Hadzi-Pavlovic, \& Parker, 1989). The LSP consists of 39 clinician-rated questions on a four-point scale and measures various aspects related to daily life activities: self-care; non-turbulence; social contact; communication; responsibility. For this project, only the self-care ratings from the full LSP-39 will be completed by service providers (items 10, 12, 13, 14, 15, 16, 23, 24, 26, and 30). While each item consists of 4 responses, the content of each response is different for each item. Overall, higher scores indicate better functioning. Max total score is 40. Min total score is 10. Current inpatient research on the use of CAT also uses this scale as a primary measure of the effectiveness of CAT. Scores will be obtained from the nursing staff not directly involved in the delivery of the finCAT intervention.

    4-Weeks Post-Intervention

  • Life Skills Profile (LSP) - Self-care Subscale

    Personal hygiene will be measured by scores on the Life Skills Profile (LSP; Rosen, Hadzi-Pavlovic, \& Parker, 1989). The LSP consists of 39 clinician-rated questions on a four-point scale and measures various aspects related to daily life activities: self-care; non-turbulence; social contact; communication; responsibility. For this project, only the self-care ratings from the full LSP-39 will be completed by service providers (items 10, 12, 13, 14, 15, 16, 23, 24, 26, and 30). While each item consists of 4 responses, the content of each response is different for each item. Overall, higher scores indicate better functioning. Max total score is 40. Min total score is 10. Current inpatient research on the use of CAT also uses this scale as a primary measure of the effectiveness of CAT. Scores will be obtained from the nursing staff not directly involved in the delivery of the finCAT intervention.

    2-Month Follow-Up

  • Goal Attainment Scaling (GAS) - Goal 1

    Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

    Baseline

  • Goal Attainment Scaling (GAS) - Goal 1

    Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

    4-Week Post-Intervention

  • Goal Attainment Scaling (GAS) - Goal 1

    Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

    2-Month Follow-Up

  • Goal Attainment Scaling (GAS) - Goal 2

    Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

    Baseline

  • Goal Attainment Scaling (GAS) - Goal 2

    Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

    4-Week Post-Intervention

  • Goal Attainment Scaling (GAS) - Goal 2

    Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

    2-Month Follow-Up

Secondary Outcomes (6)

  • Evidence-Based Practice Attitude Scale (EBPAS)

    Baseline

  • Evidence-Based Practice Attitude Scale (EBPAS)

    2-Month Follow-Up

  • Essen Climate Evaluation Schema (Essen CES)

    Baseline

  • Essen Climate Evaluation Schema (Essen CES)

    2-Month Follow-Up

  • Qualitative Care Provider Attitudes

    2 months after month of service implementation

  • +1 more secondary outcomes

Study Arms (1)

Inpatient Clients

Have a chart diagnosis of a schizophrenia spectrum illness, capacity to consent or availability of a substitute decision-maker to consent with the assent of the participant and is residing on a CAMH inpatient forensic unit (general security)

Other: Cognitive Adaptation Training (CAT)

Interventions

Cognitive Adaptation Training (CAT) is a standardized implementation of environmental supports for improving adaptive functioning including medication adherence, grooming, and daily activities in patients with schizophrenia. Environmental supports (signs, checklists) are manual-driven and grounded upon an assessment of neurocognitive function and behaviour. Assessment results yield one of six CAT classifications (Apathy/Poor Executive Functioning, Disinhibited/Poor EF, Mixed/Poor EF, Apathy/Fair EF, Disinhibited/Fair EF, Mixed/Fair EF).The goal will be to improve organization and self-care, modifying the intervention to be more relevant for an inpatient setting. Once an individual's CAT classification has been determined, strategies for specific functional problems are chosen from a series of tables. CAT interventions are maintained in the client's living space during weekly visits. CAT clinicians will encourage team members to assist with the reinforcement of CAT tools and strategies.

Inpatient Clients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants will be recruited through CAMH Complex Care \& Recovery inpatient forensic services.

You may qualify if:

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

You may not qualify if:

  • High paranoia
  • Primary issue of hoarding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (25)

  • 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
  • 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.

    PMID: 15224451BACKGROUND
  • 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.

    PMID: 11040880BACKGROUND
  • 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.

    PMID: 29194005BACKGROUND
  • 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
  • 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.

    BACKGROUND
  • 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.

    PMID: 16368053BACKGROUND
  • 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.

    PMID: 8610818BACKGROUND
  • Harvey, P. D. (Ed.). (2013). Cognitive impairment in schizophrenia: Characteristics, assessment and treatment. Cambridge University Press.

    BACKGROUND
  • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

    PMID: 16204405BACKGROUND
  • 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
  • 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.

    BACKGROUND
  • 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.

    PMID: 2749191BACKGROUND
  • 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.

    PMID: 18229876BACKGROUND
  • 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.

    PMID: 25887511BACKGROUND
  • 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.

    PMID: 11141527BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 10910797BACKGROUND
  • 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.

    PMID: 12693434BACKGROUND
  • 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.

    PMID: 12719495BACKGROUND
  • 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.

    PMID: 17932089BACKGROUND
  • 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.

    PMID: 18374542BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

Sample size is lower than what would be ideal for feasibility trials and leave analyses under-powered to a degree. Lack of a control group limiting generalizability. Due to the COVID-19 pandemic, adaptations were made to the study design to accommodate procedural changes and patient safety.

Results Point of Contact

Title
Courtney Brennan
Organization
Centre for Addiction and Mental Health

Study Officials

  • Sean Kidd

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Psychology Division, Senior Scientist

Study Record Dates

First Submitted

February 11, 2020

First Posted

March 4, 2020

Study Start

December 12, 2019

Primary Completion

June 20, 2020

Study Completion

June 30, 2020

Last Updated

January 26, 2023

Results First Posted

January 26, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Client-specific research data gathered as part of this study may be shared and provided to the paticipant's unit treatment team for client care. All client data gathered will be kept confidential within the participant's treatment team and the research project team. All other gathered data (i.e. staff data) will be kept de-identified, confidential, and anonymous.

Locations