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

Not Applicable

• Conditions: Schizoaffective Disorder; Mood Disorders; Schizophrenia
• Interventions: Behavioral: compensatory cognitive treatment

• Registration Number: NCT04551027
• Lead Sponsor: Shalvata Mental Health Center

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.

Study Timeline

• Study First Submitted: 2020-08-14
• Status Verified: 2020-09
• Study Start: 2020-09
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-16
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compensatory cognitive treatment	compensatory cognitive treatment	compensatory cognitive treatment intervention, focusing on learning cognitive strategies to overcome cognitive deficits.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: 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 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: 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: 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.
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.

Trial Locations

Locations (1)

Shalvata mental health center; 🇮🇱 Hod HaSharon, Israel