Mood Disorders, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
compensatory cognitive treatment, mental illness, cognitive strategies, everyday functioning
Brief summary
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
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.
Interventions
BEHAVIORALcompensatory cognitive treatment
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
Sponsors
Tel Aviv University
Shalvata Mental Health Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R) | 30 min duration at week 0 ; week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI) | week 0 ; week 12 | 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) |
| Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT) | 20 min at week 0 ; week 12 | 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) |
| Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure | 20 min at week 0 ; week 12 | 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). |
| Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA) | 10 min at week 0 ; week 12 | 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) |
| Change from baseline cognitive functions at 12 weeks: Behavioral Assessment of the Dysexecutive Syndrome (BADS): key searching test | 1 min at week 0 ; week 12 | a cognitive performance test evaluating problem solving, regulating and monitoring behavior. The final score ranges from 0-4, Higher score is a better result. |
| Change from baseline cognitive functions at 12 weeks: Category Fluency Test (CFT) | 1 min at week 0 ; week 12 | 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. |
| Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT) | 3 min at week 0 ; week 12 | 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. |
Countries
Israel
Contacts
Primary ContactMiryam Ben Zaken, B.O.T
Outcome results
None listed