Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 17, 2020
September 1, 2020
1 year
August 14, 2020
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA)
10 min at week 0 ; week 12
Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI)
week 0 ; week 12
Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT)
20 min at week 0 ; week 12
Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure
20 min at week 0 ; week 12
Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT)
3 min at week 0 ; week 12
- +2 more secondary outcomes
Study Arms (2)
compensatory cognitive treatment
EXPERIMENTALcompensatory cognitive treatment intervention, focusing on learning cognitive strategies to overcome cognitive deficits.
control group
NO INTERVENTIONstandard ambulatory treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shalvata Mental Health Centerlead
- Tel Aviv Universitycollaborator
Study Sites (1)
Shalvata mental health center
Hod HaSharon, 4534708, Israel
Related 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(Suppl 2):S55-62. doi: 10.1093/schbul/sbr059.
PMID: 21860048BACKGROUNDTwamley 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.
PMID: 19198664BACKGROUNDTwamley 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.
PMID: 28823720BACKGROUNDTwamley 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.
PMID: 22939029BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ido Lurie, M.D
Director of Adult clinic, Shalvata Mental Health Center
- STUDY DIRECTOR
Lena Lipskaya, P.H.D
The Department of Occupational Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine,Tel Aviv University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of adult clinic
Study Record Dates
First Submitted
August 14, 2020
First Posted
September 16, 2020
Study Start
September 1, 2020
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
September 17, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share