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临床试验/NCT04294719
NCT04294719已完成不适用

A Study of Cognitive Adaptation Training in Inpatient Forensic Environments

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Life Skills Profile (LSP) - Self-Care Subscale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • Exclusion Criteria
  • High paranoia
  • Primary issue of hoarding

排除标准

  • 未提供

结局指标

主要结局

Life Skills Profile (LSP) - Self-Care Subscale

时间窗: 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.

Clutter Image Rating Scale (CIRS) - Patient-rated

时间窗: 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.

Goal Attainment Scaling (GAS) - Goal 1

时间窗: 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.

Clutter Image Rating Scale (CIRS) - Blind-rated

时间窗: 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.

Goal Attainment Scaling (GAS) - Goal 2

时间窗: 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.

Life Skills Profile (LSP) - Self-care Subscale

时间窗: 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.

次要结局

  • Qualitative Care Provider Attitudes(2 months after month of service implementation)
  • Evidence-Based Practice Attitude Scale (EBPAS)(2-Month Follow-Up)
  • Essen Climate Evaluation Schema (Essen CES)(2-Month Follow-Up)
  • Qualitative Participant Attitudes(2 months after month of service implementation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Kidd

Chief of Psychology Division, Senior Scientist

Centre for Addiction and Mental Health

研究点 (1)

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