SchizophreniafinCATNCT04294719
A Study of Cognitive Adaptation Training in Inpatient Forensic Environments
An observational study of Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive Adaptation Training (CAT)
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2019to 30 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants will be recruited through CAMH Complex Care \& Recovery inpatient forensic services.
Who may be able to join
- 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)
Who cannot join
- High paranoia
- Primary issue of hoarding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Schizophrenia
- Being tested
- Cognitive Adaptation Training (CAT)
- Keywords
- Schizophrenia, Cognitive Adaptation Training, Forensic, Inpatient, Cognition, Environmental Supports
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Adaptation Training (CAT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Cognitive Adaptation Training (CAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-Month Follow-Up
Secondary outcomes (6)
Evidence-Based Practice Attitude Scale (EBPAS)
The attitudes of the team members towards finCAT will be measured using the Evidence-Based Practice Attitude Scale (EPBAS; Aarons, 2004) adapted to specifically target attitudes towards CAT. The EPBAS is a self-report questionnaire consisting of 36 items measured on a 5-point Likert scale ranging from 0 ('Not at all') to 4 ('To a very great extent') and consists of 12 subscales. Maximum is 4. Minimum is 0. Higher scores indicate a more open attitude towards new types of therapy, interventions or treatments including manualized therapy.
Measured: Baseline
Evidence-Based Practice Attitude Scale (EBPAS)
The attitudes of the team members towards finCAT will be measured using the Evidence-Based Practice Attitude Scale (EPBAS; Aarons, 2004) adapted to specifically target attitudes towards CAT. The EPBAS is a self-report questionnaire consisting of 36 items measured on a 5-point Likert scale ranging from 0 ('Not at all') to 4 ('To a very great extent') and consists of 12 subscales. Maximum is 4. Minimum is 0. Higher scores indicate a more open attitude towards new types of therapy, interventions or treatments including manualized therapy.
Measured: 2-Month Follow-Up
Essen Climate Evaluation Schema (Essen CES)
The therapeutic alliance on the unit will be measured by clinician and client ratings on the Essen Climate Evaluation Schema (Essen CES; Schalast et al., 2008). The Essen CES is a 15-item questionnaire measured on a 5-point Likert scale ranging from 'Not at all' to 'Very Much' and consists of three subscales: (1) Patient's Cohesion, (2) Experienced Safety, and (3) Therapeutic Hold. For this study, client and clinician ratings on the Therapeutic Hold and Experienced safety subscales will be collected. For each sub-scale, the max is 20 and minimum is 0. Higher scores indicate greater experienced safety and therapeutic hold.
Measured: Baseline
Essen Climate Evaluation Schema (Essen CES)
The therapeutic alliance on the unit will be measured by clinician and client ratings on the Essen Climate Evaluation Schema (Essen CES; Schalast et al., 2008). The Essen CES is a 15-item questionnaire measured on a 5-point Likert scale ranging from 'Not at all' to 'Very Much' and consists of three subscales: (1) Patient's Cohesion, (2) Experienced Safety, and (3) Therapeutic Hold. For this study, client and clinician ratings on the Therapeutic Hold and Experienced safety subscales will be collected. For each sub-scale, the max is 20 and minimum is 0. Higher scores indicate greater experienced safety and therapeutic hold.
Measured: 2-Month Follow-Up
Qualitative Care Provider Attitudes
The attitudes of the team members towards finCAT will also be measured using a qualitative feedback form created for this study. Questions will target attitudes towards finCAT, perceptions of the impact of finCAT, and perceptions of team tension or conflict arising or abating during the implementation of finCAT. Small focus groups with healthcare providers will be facilitated by student investigators. Interviews will be audio-recorded and transcribed verbatim.
Measured: 2 months after month of service implementation
Qualitative Participant Attitudes
The attitudes of the participants towards finCAT will also be measured using a qualitative feedback form created for this study. Questions will target attitudes towards finCAT, perceptions of the impact of finCAT. Individual interviews with interested clients will be facilitated by student investigators. Interviews will be audio-recorded and transcribed verbatim.
Measured: 2 months after month of service implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start12 Dec 2019
- Primary completion20 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
- Investigators
- Sean Kidd, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294719
- Sponsor's protocol ID
- 115-2019
- Acronym
- finCAT
- Status last verified
- Apr 2022
- First submitted
- 11 Feb 2020
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 2602512Aarons 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.
PubMed 15224451Brown 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.
PubMed 11040880Chen 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.
PubMed 29194005Draper 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.
PubMed 19521972Frost, 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.
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.
PubMed 16368053Green 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.
PubMed 8610818Harvey, P. D. (Ed.). (2013). Cognitive impairment in schizophrenia: Characteristics, assessment and treatment. Cambridge University Press.
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Kidd 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.
PubMed 24794880Maples, 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.
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.
PubMed 2749191Schalast 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.
PubMed 18229876Stiekema 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.
PubMed 25887511
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cognitive Adaptation Training in Inpatient Forensic Environments
- ClinicalTrials.gov ID
- NCT04294719
- Acronym / sponsor ID
- finCAT / 115-2019
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cognitive Adaptation Training, Forensic, Inpatient, Cognition, Environmental Supports
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient Clients | – | Other: Cognitive Adaptation Training (CAT)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be recruited through CAMH Complex Care \& Recovery inpatient forensic services.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- High paranoia
- Primary issue of hoarding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Adaptation Training (CAT)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. | Other | Inpatient Clients |
Primary outcome
Clutter Image Rating Scale (CIRS) - Blind-rated
Time frame: Baseline
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.
Clutter Image Rating Scale (CIRS) - Blind-rated
Time frame: 4-Weeks Post-Intervention
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.
Clutter Image Rating Scale (CIRS) - Blind-rated
Time frame: 2-Month Follow-Up
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.
Clutter Image Rating Scale (CIRS) - Patient-rated
Time frame: Baseline
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.
Clutter Image Rating Scale (CIRS) - Patient-rated
Time frame: 4-Weeks Post-Intervention
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.
Life Skills Profile (LSP) - Self-Care Subscale
Time frame: Baseline
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.
Life Skills Profile (LSP) - Self-care Subscale
Time frame: 4-Weeks Post-Intervention
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.
Life Skills Profile (LSP) - Self-care Subscale
Time frame: 2-Month Follow-Up
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.
Goal Attainment Scaling (GAS) - Goal 1
Time frame: Baseline
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.
Goal Attainment Scaling (GAS) - Goal 1
Time frame: 4-Week Post-Intervention
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.
Goal Attainment Scaling (GAS) - Goal 1
Time frame: 2-Month Follow-Up
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.
Goal Attainment Scaling (GAS) - Goal 2
Time frame: Baseline
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.
Goal Attainment Scaling (GAS) - Goal 2
Time frame: 4-Week Post-Intervention
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.
Goal Attainment Scaling (GAS) - Goal 2
Time frame: 2-Month Follow-Up
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.
6 secondary outcomes
Evidence-Based Practice Attitude Scale (EBPAS)
Time frame: Baseline
Evidence-Based Practice Attitude Scale (EBPAS)
Time frame: 2-Month Follow-Up
Essen Climate Evaluation Schema (Essen CES)
Time frame: Baseline
Essen Climate Evaluation Schema (Essen CES)
Time frame: 2-Month Follow-Up
Qualitative Care Provider Attitudes
Time frame: 2 months after month of service implementation
Qualitative Participant Attitudes
Time frame: 2 months after month of service implementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2602512Alphs 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.
- Background: PubMed 15224451Aarons 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.
- Background: PubMed 11040880Brown 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.
- Background: PubMed 29194005Chen 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.
- Background: PubMed 19521972Draper 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.
- BackgroundFrost, 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: PubMed 16368053Goeree 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.
- Background: PubMed 8610818Green 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.
- BackgroundHarvey, P. D. (Ed.). (2013). Cognitive impairment in schizophrenia: Characteristics, assessment and treatment. Cambridge University Press.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Background: PubMed 24794880Kidd 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.
- BackgroundMaples, 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Kidd principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clutter Image Rating Scale (CIRS) - Blind-rated (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294719, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.