Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
Primary Purpose
Mood Disorders, Schizophrenia, Schizoaffective Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
compensatory cognitive treatment
Sponsored by
About this trial
This is an interventional treatment trial for Mood Disorders focused on measuring compensatory cognitive treatment, mental illness, cognitive strategies, everyday functioning
Eligibility Criteria
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
Sites / Locations
- Shalvata mental health center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
compensatory cognitive treatment
control group
Arm Description
compensatory cognitive treatment intervention, focusing on learning cognitive strategies to overcome cognitive deficits.
standard ambulatory treatment
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
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)
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)
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).
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.
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.
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.
Full Information
NCT ID
NCT04551027
First Posted
August 14, 2020
Last Updated
September 16, 2020
Sponsor
Shalvata Mental Health Center
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT04551027
Brief Title
Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
Official Title
Assessing the Effect of Compensatory Cognitive Intervention for Functional Capacity, Cognitive Functions and Severity of Symptoms Among People With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shalvata Mental Health Center
Collaborators
Tel Aviv University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Schizophrenia, Schizoaffective Disorder
Keywords
compensatory cognitive treatment, mental illness, cognitive strategies, everyday functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
compensatory cognitive treatment
Arm Type
Experimental
Arm Description
compensatory cognitive treatment intervention, focusing on learning cognitive strategies to overcome cognitive deficits.
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard ambulatory treatment
Intervention Type
Behavioral
Intervention Name(s)
compensatory cognitive treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R)
Description
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).
Time Frame
30 min duration at week 0 ; week 12
Secondary Outcome Measure Information:
Title
Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA)
Description
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)
Time Frame
10 min at week 0 ; week 12
Title
Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI)
Description
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)
Time Frame
week 0 ; week 12
Title
Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT)
Description
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)
Time Frame
20 min at week 0 ; week 12
Title
Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure
Description
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).
Time Frame
20 min at week 0 ; week 12
Title
Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT)
Description
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.
Time Frame
3 min at week 0 ; week 12
Title
Change from baseline cognitive functions at 12 weeks: Behavioral Assessment of the Dysexecutive Syndrome (BADS): key searching test
Description
a cognitive performance test evaluating problem solving, regulating and monitoring behavior. The final score ranges from 0-4, Higher score is a better result.
Time Frame
1 min at week 0 ; week 12
Title
Change from baseline cognitive functions at 12 weeks: Category Fluency Test (CFT)
Description
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.
Time Frame
1 min at week 0 ; week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miryam Ben Zaken, B.O.T
Phone
+972- 546305247
Email
miryambz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ido Lurie, M.D
Organizational Affiliation
Director of Adult clinic, Shalvata Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lena Lipskaya, P.H.D
Organizational Affiliation
The Department of Occupational Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine,Tel Aviv University
Official's Role
Study Director
Facility Information:
Facility Name
Shalvata mental health center
City
Hod HaSharon
ZIP/Postal Code
4534708
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miryam ben zaken, B.O.T
Phone
+972-546305247
Email
miryambz@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21860048
Citation
Twamley EW, Burton CZ, Vella L. Compensatory cognitive training for psychosis: who benefits? Who stays in treatment? Schizophr Bull. 2011 Sep;37 Suppl 2(Suppl 2):S55-62. doi: 10.1093/schbul/sbr059.
Results Reference
background
PubMed Identifier
19198664
Citation
Twamley EW, Savla GN, Zurhellen CH, Heaton RK, Jeste DV. Development and Pilot Testing of a Novel Compensatory Cognitive Training Intervention for People with Psychosis. Am J Psychiatr Rehabil. 2008 Apr;11(2):144-163. doi: 10.1080/15487760801963678.
Results Reference
background
PubMed Identifier
28823720
Citation
Twamley EW, Thomas KR, Burton CZ, Vella L, Jeste DV, Heaton RK, McGurk SR. Compensatory cognitive training for people with severe mental illnesses in supported employment: A randomized controlled trial. Schizophr Res. 2019 Jan;203:41-48. doi: 10.1016/j.schres.2017.08.005. Epub 2017 Aug 18.
Results Reference
background
PubMed Identifier
22939029
Citation
Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7.
Results Reference
background
Links:
URL
http://www.cogsmart.com/
Description
A website which gives free access to the manuals of the CCT intervention
Learn more about this trial
Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
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