finCAT: A Study of Cognitive Adaptation Training in Inpatient Forensic Environments

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Suspended
CT.gov ID
NCT04294719
Collaborator
(none)
24
1
30.6
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Adaptation Training (CAT)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Study of Cognitive Adaptation Training in Inpatient Forensic Environments
Actual Study Start Date :
Dec 12, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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)
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.

Outcome Measures

Primary Outcome Measures

  1. Clutter Image Rating Scale (CIRS) [Baseline (2 weeks before service implementation)]

    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). 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. Clutter Image Rating Scale (CIRS) [1 week before month of service implementation]

    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). 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.

  3. Clutter Image Rating Scale (CIRS) [1 week after month of service implementation]

    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). 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. Clutter Image Rating Scale (CIRS) [2 months after month of service implementation]

    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). 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.

  5. Goal Attainment Scaling (GAS) [1 week before month of service implementation]

    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 3-point scale. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

  6. Goal Attainment Scaling (GAS) [1 week after month of service implementation]

    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 3-point scale. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

  7. Goal Attainment Scaling (GAS) [2 months after month of service implementation]

    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 3-point scale. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.

  8. Life Skills Profile (LSP) [Baseline (2 weeks before service implementation)]

    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. 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.

  9. Life Skills Profile (LSP) [1 week before month of service implementation]

    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. 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.

  10. Life Skills Profile (LSP) [1 week after month of service implementation]

    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. 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.

  11. Life Skills Profile (LSP) [2 months after month of service implementation]

    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. 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.

Secondary Outcome Measures

  1. Evidence-Based Practice Attitude Scale (EBPAS) [Baseline (2 weeks before service implementation)]

    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 15 items measured on a 5-point Likert scale ranging from 0 ('Not at all') to 4 ('To a very great extent') and consists of four subscales: (1) appeal, (2) requirements, (3) openness and (4) divergence.

  2. Evidence-Based Practice Attitude Scale (EBPAS) [2 months after month of service implementation]

    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 15 items measured on a 5-point Likert scale ranging from 0 ('Not at all') to 4 ('To a very great extent') and consists of four subscales: (1) appeal, (2) requirements, (3) openness and (4) divergence.

  3. Essen Climate Evaluation Schema (Essen CES) [Baseline (2 weeks before service implementation)]

    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 subscale will be collected.

  4. Essen Climate Evaluation Schema (Essen CES) [2 months after month of service implementation]

    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 subscale will be collected.

  5. Qualitative Care Provider Attitudes [2 months after month of service implementation]

    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.

  6. Qualitative Participant Attitudes [2 months after month of service implementation]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Addiction and Mental Health Toronto Ontario Canada M6J 1H4

Sponsors and Collaborators

  • Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Sean Kidd, Centre for Addiction and Mental Health

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Sean Kidd, Chief of Psychology Division, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT04294719
Other Study ID Numbers:
  • 115-2019
First Posted:
Mar 4, 2020
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sean Kidd, Chief of Psychology Division, Senior Scientist, Centre for Addiction and Mental Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2021