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

NCT ID: NCT04551027

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Mood Disorders Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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compensatory cognitive treatment

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

Group Type EXPERIMENTAL

compensatory cognitive treatment

Intervention Type BEHAVIORAL

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

control group

standard ambulatory treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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ido lurie

Director of adult clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ido Lurie, M.D

Role: PRINCIPAL_INVESTIGATOR

Director of Adult clinic, Shalvata Mental Health Center

Lena Lipskaya, P.H.D

Role: STUDY_DIRECTOR

The Department of Occupational Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine,Tel Aviv University

Locations

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Shalvata mental health center

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Central Contacts

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Miryam Ben Zaken, B.O.T

Role: CONTACT

+972- 546305247

Facility Contacts

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Miryam ben zaken, B.O.T

Role: primary

+972-546305247

References

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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.

Reference Type BACKGROUND
PMID: 21860048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19198664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28823720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22939029 (View on PubMed)

Related Links

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http://www.cogsmart.com/

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

Other Identifiers

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0003-20-SHA

Identifier Type: -

Identifier Source: org_study_id

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