Clinical trial NCT04551027: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mood Disorders
Schizophrenia
Schizoaffective Disorder
Keywords: compensatory cognitive treatment
mental illness
cognitive strategies
everyday functioning
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2020-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R)
timeFrame: 30 min duration at week 0 ; week 12
Secondary outcomes:
measure: Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA)
timeFrame: 10 min at week 0 ; week 12
measure: Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI)
timeFrame: week 0 ; week 12
measure: Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT)
timeFrame: 20 min at week 0 ; week 12
measure: Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure
timeFrame: 20 min at week 0 ; week 12
measure: Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT)
timeFrame: 3 min at week 0 ; week 12
measure: Change from baseline cognitive functions at 12 weeks: Behavioral Assessment of the Dysexecutive Syndrome (BADS): key searching test
timeFrame: 1 min at week 0 ; week 12
measure: Change from baseline cognitive functions at 12 weeks: Category Fluency Test (CFT)
timeFrame: 1 min at week 0 ; week 12
Other outcomes:
Locations:
city: Hod HaSharon
country: Israel
facility: Shalvata mental health center
Study officials:
affiliation: Director of Adult clinic, Shalvata Mental Health Center
name: Ido Lurie, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Department of Occupational Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine,Tel Aviv University
name: Lena Lipskaya, P.H.D
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.