Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of a short term compensatory cognitive group intervention - the Compensatory Cognitive Training (CCT) among people with severe mental illnesses, receiving ambulatory treatment

Detailed Description
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This study includes two experimental arms to research cognitive compensatory group treatment in severe mental illness population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve an ambulatory participants. participants are assigned to an intervention or control group according to the order of recruitment. Assessment and post-assessment phases include assessments of functional capacity, cognitive functions and severity of symptoms. Intervention includes 12 group sessions in a small group of five participants, focusing on learning compensatory strategies aimed to improve attention, concentration, learning, memory, organization, and problem-solving in order to improve everyday functioning. Interventions will be performed in addition to standard ambulatory treatment. The control group will receive standard ambulatory treatment only.

Official Title
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Assessing the Effect of Compensatory Cognitive Intervention for Functional Capacity, Cognitive Functions and Severity of Symptoms Among People With Severe Mental Illness

Conditions
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Mood Disorders, Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: compensatory cognitive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: basic knowledge in Hebrew diagnosed according to the ICD -10 with severe mental illness: schizophrenia, bipolar disease, schizoaffective disorder or major depression Patients are treated with neuroleptic medication for at least four weeks. Exclusion Criteria: acquired neurological disorders including dementia and brain injury. Developmental neurological disorders including developmental intellectual disability and autistic spectrum disorders. Regular Electro convulsive therapy treatment with frequency of twice a month or more. People to whom a guardian has been appointed Current addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: compensatory cognitive treatment<br>compensatory cognitive treatment intervention, focusing on learning cognitive strategies to overcome cognitive deficits. | Behavioral: compensatory cognitive treatment<br>* a brief group compensatory cognitive intervention including 12 meetings of 1 hour in a group of five and focuses on these cognitive domains: prospective memory, vigilance and attention, memory and learning and executive functions<br>|
| No Intervention: control group<br>standard ambulatory treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R) | OTDL-R is an objective, performance-based evaluation of the subjects' ability to perform daily life activities in the following areas: Medication management, communication and finances management. The final score ranges from 0 (not independent) to 28 (independent). | 30 min duration at week 0 ; week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA) | CPSA is a self-reported questionnaire on personal experience of cognitive difficulties and usage of cognitive strategies. The final score for each scale ranges from 0 (Rarely/ Never) to 3 (always) | 10 min at week 0 ; week 12 | 
| Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI) | a scale used by the clinician to assess the severity of symptoms according to symptoms, behaviour and function in the last week. The final score ranges from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients) | week 0 ; week 12 | 
| Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT) | COGNISTAT is a cognitive screening test for 3 basic cognitive functions: Orientation, Attention, Memory Registration and 5 major cognitive functions: Language (Comprehension, Repetition, Naming), Constructional Ability, Memory, Calculation Skills, Executive Skills (Reasoning, Judgment). The final scores for the subtests ranges from 0 (severe impairment) to 4, 6, 8 or 12 (average range) | 20 min at week 0 ; week 12 | 
| Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure | a cognitive performance test evaluating instant visual memory and visual organization. The final score for accuracy ranges from 0-36 as higher score indicate better accuracy. The final score for the general performance of the task ranges from 1 (very reasonable) to 7 (not at all reasonable). | 20 min at week 0 ; week 12 | 
| Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT) | Paper and pencil neuropsychological test that evaluating processing speed and shifting. The final score represents the time length in which the subject completed the test. | 3 min at week 0 ; week 12 | 
| Change from baseline cognitive functions at 12 weeks: Behavioral Assessment of the Dysexecutive Syndrome (BADS): key searching test | a cognitive performance test evaluating problem solving, regulating and monitoring behavior. The final score ranges from 0-4, Higher score is a better result. | 1 min at week 0 ; week 12 | 
| Change from baseline cognitive functions at 12 weeks: Category Fluency Test (CFT) | A neuropsychological test evaluating the ability to retrieve information from memory in a limited amount of time. The final score represents the number of words the subject succeeded to retrieve in the limited time. Higher score is a better result. | 1 min at week 0 ; week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compensatory cognitive treatment, mental illness, cognitive strategies, everyday functioning