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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04551027
• Other study ID #: 0003-20-SHA
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2020
• Source: Shalvata Mental Health Center
• Contact: Miryam Ben Zaken, B.O.T
• Phone: +972- 546305247
• Email: miryambz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• compensatory 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

Locations

Country	Name	City	State
Israel	Shalvata mental health center	Hod HaSharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Twamley EW, Burton CZ, Vella L. Compensatory cognitive training for psychosis: who benefits? Who stays in treatment? Schizophr Bull. 2011 Sep;37 Suppl 2:S55-62. doi: 10.1093/schbul/sbr059. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   A website which gives free access to the manuals of the CCT intervention