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Mood DisordersNCT04551027

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

A study testing compensatory cognitive treatment in people with Mood Disorders and Schizophrenia, run by Shalvata Mental Health Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
compensatory cognitive treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIsrael
Study dates
Sep 2020to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Miryam Ben Zaken, B.O.T contact

+972- 546305247

miryambz@gmail.com

Israel1 site

  • Shalvata mental health center

    Hod HaSharon, 4534708

    Miryam ben zaken, B.O.T, +972-546305247, miryambz@gmail.com

Other trials in Israel

About this study

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

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

Read the 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.

Being tested
compensatory cognitive treatment
Keywords
compensatory cognitive treatment, mental illness, cognitive strategies, everyday functioning
Medical subject headings
Mood Disorders, Schizophrenia, Psychotic Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • compensatory cognitive treatmentBehavioural

    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

Study groups in NCT04551027
Study groupRoleWhat they receive
compensatory cognitive treatmentExperimentalcompensatory cognitive treatment intervention, focusing on learning cognitive strategies to overcome cognitive deficits.
Receives: Behavioral: compensatory cognitive treatment
control groupNo interventionstandard ambulatory treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 30 min duration at week 0 ; week 12

Secondary outcomes (7)

  1. 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)

    Measured: 10 min at week 0 ; week 12

  2. 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)

    Measured: week 0 ; week 12

  3. 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)

    Measured: 20 min at week 0 ; week 12

  4. 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).

    Measured: 20 min at week 0 ; week 12

  5. 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.

    Measured: 3 min at week 0 ; week 12

  6. 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.

    Measured: 1 min at week 0 ; week 12

  7. 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.

    Measured: 1 min at week 0 ; week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551027
Sponsor's protocol ID
0003-20-SHA
Status last verified
Sep 2020
First submitted
14 Aug 2020
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21860048

  • 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.

    PubMed 19198664

  • 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.

    PubMed 28823720

  • 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.

    PubMed 22939029

Questions about this trial

What is this clinical trial studying?

A study testing compensatory cognitive treatment in people with Mood Disorders and Schizophrenia, run by Shalvata Mental Health Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Miryam Ben Zaken, B.O.T (+972- 546305247, miryambz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R) (time frame: 30 min duration at week 0 ; week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551027, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.

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