Affective DisorderNCT04288609
Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder
A study testing Intendu and Paper and Pencil cognitive remediation training in people with Affective Disorder, run by Geha Mental Health Center.
Trial summary
The purpose of this study is to test the efficacy of remedial cognitive intervention using The Functional Brain Trainer VR (FBT, Intendo ©) to improve cognitive functioning, participation in daily life occupations, and functional capacity in the field of IADL among people with affective disorders receiving inpatient… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Affective Disorder
- What is being tested?
- Intendu and Paper and Pencil cognitive remediation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to 1 Dec 2020
- 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
- Age 18-60,
- Diagnosis of Major Depression or Bipolar disorder based on DSM-5;
- Mood stabilizing medication for at least 2 weeks,
Who cannot join
- Neurological disorders and neuro-developmental conditions in addition to mental health diagnosis;
- Physical disability in addition to mental health conditions;
- Psychotic state;
- active substance abuse;
- custodian
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to test the efficacy of remedial cognitive intervention using The Functional Brain Trainer VR (FBT, Intendo ©) to improve cognitive functioning, participation in daily life occupations, and functional capacity in the field of IADL among people with affective disorders receiving inpatient and daycare mental-health services.
Read the detailed description
This study is an experimental study, in a pre-post design with a control group, the sampling is convenience. The study will include 40 people aged 18-60 with a diagnosis of Affective disorder based on DSM-5.
Inclusion criteria: age 18-60, Diagnosis of Major Depression or Bipolar disorder based on DSM-5; Mood stabilizing medication for at least 2 weeks, Exclusion criteria: Neurological disorders and neurodevelopmental conditions in addition to mental health diagnosis; Physical disability in addition to mental health conditions; Psychotic state; active substance abuse; custodian.
They will be recruited from active inpatient and daycare wards of the "Geha Mental Health Center", Israel and will be randomly allocated into two groups: experimental and control. An experimental group will attend 6 VR based cognitive remediation sessions of 30 minutes for training response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence. The control group will complete 6 sessions of 30 minutes of low-tech (paper and pencil tasks) remedial training of the same cognitive components. These in addition to routine care. The evaluation for symptoms severity, cognition, functional capacity and participation in daily life activities will be conducted at the beginning of the study and after about 4 weeks.
- Conditions
- Affective Disorder
- Being tested
- Intendu, Paper and Pencil cognitive remediation training
- Keywords
- affective disorder
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntenduOther
Also called Motion Based Cognitive Video Games Software
Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Paper and Pencil cognitive remediation trainingOther
Also called Low-Tech remedial training
Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
| Study group | Role | What they receive |
|---|---|---|
| Intendu FBT inpatient | Experimental | Motion Based Cognitive Video Games Software Receives: Other: Intendu |
| paper and pencil tasks | Active comparator | paper and pencil tasks Receives: Other: Paper and Pencil cognitive remediation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Observed Tasks of Daily Living - Revised
Assessment of Functional capacity, score range 1 (dependent in the performance of daily life activities) up to 26 (fully independent in the performance of the daily life activities)
Measured: 3 weeks
Adults Subjective Assessment of Participation
Questionnaire for assessment of participation in daily life activities: number of participated activities (from 1 to 52, the higher number indicates higher number of participated activities) and frequency of the participation (range from 1 indicates low frequency of participation up to 7 - higher frequency of the participation)
Measured: 3 weeks
Secondary outcomes (4)
The Neurobehavioral Cognitive Status Examination
Examination cognitive components of attention language, spatial skills, memory, calculations and reasoning. The score range for different sub-tests from 1 up to 4, 6, 8 or 12, with higher score indicates better cognitive functioning
Measured: 3 weeks
Trail Making Test A & B
Measure of cognitive flexibility and psycho-motor processing speed, the score is a time needed for the test completion, less time that needed indicates better cognitive functioning
Measured: 3 weeks
Category Fluency Test
Assessment of language fluency, the score is a number of produced words, the higher the number, the better cognitive fluency
Measured: 3 weeks
Hamilton Depression Rating Scale Questionnaire
Assessment of the depressive symptoms, the higher score indicates more severe depressive symptoms.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startMar 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geha Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288609
- Sponsor's protocol ID
- Geha Mental Health Center
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder
- ClinicalTrials.gov ID
- NCT04288609
- Acronym / sponsor ID
- Geha Mental Health Center
- Conditions
- Affective Disorder
- Keywords
- affective disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Geha Mental Health CenterUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Mar 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the efficacy of remedial cognitive intervention using The Functional Brain Trainer VR (FBT, Intendo ©) to improve cognitive functioning, participation in daily life occupations, and functional capacity in the field of IADL among people with affective disorders receiving inpatient and daycare mental-health services.
Detailed description
This study is an experimental study, in a pre-post design with a control group, the sampling is convenience. The study will include 40 people aged 18-60 with a diagnosis of Affective disorder based on DSM-5.
Inclusion criteria: age 18-60, Diagnosis of Major Depression or Bipolar disorder based on DSM-5; Mood stabilizing medication for at least 2 weeks, Exclusion criteria: Neurological disorders and neurodevelopmental conditions in addition to mental health diagnosis; Physical disability in addition to mental health conditions; Psychotic state; active substance abuse; custodian.
They will be recruited from active inpatient and daycare wards of the "Geha Mental Health Center", Israel and will be randomly allocated into two groups: experimental and control. An experimental group will attend 6 VR based cognitive remediation sessions of 30 minutes for training response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence. The control group will complete 6 sessions of 30 minutes of low-tech (paper and pencil tasks) remedial training of the same cognitive components. These in addition to routine care. The evaluation for symptoms severity, cognition, functional capacity and participation in daily life activities will be conducted at the beginning of the study and after about 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intendu FBT inpatient | Experimental | Other: IntenduMotion Based Cognitive Video Games Software |
| paper and pencil tasks | Active comparator | Other: Paper and Pencil cognitive remediation trainingpaper and pencil tasks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60,
- Diagnosis of Major Depression or Bipolar disorder based on DSM-5;
- Mood stabilizing medication for at least 2 weeks,
Key exclusion criteria (5 listed)
- Neurological disorders and neuro-developmental conditions in addition to mental health diagnosis;
- Physical disability in addition to mental health conditions;
- Psychotic state;
- active substance abuse;
- custodian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntenduAlso: Motion Based Cognitive Video Games SoftwareCognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence. | Other | Intendu FBT inpatient |
| Paper and Pencil cognitive remediation trainingAlso: Low-Tech remedial trainingCognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence. | Other | paper and pencil tasks |
Primary outcome
The Observed Tasks of Daily Living - Revised
Time frame: 3 weeks
Assessment of Functional capacity, score range 1 (dependent in the performance of daily life activities) up to 26 (fully independent in the performance of the daily life activities)
Adults Subjective Assessment of Participation
Time frame: 3 weeks
Questionnaire for assessment of participation in daily life activities: number of participated activities (from 1 to 52, the higher number indicates higher number of participated activities) and frequency of the participation (range from 1 indicates low frequency of participation up to 7 - higher frequency of the participation)
4 secondary outcomes
The Neurobehavioral Cognitive Status Examination
Time frame: 3 weeks
Trail Making Test A & B
Time frame: 3 weeks
Category Fluency Test
Time frame: 3 weeks
Hamilton Depression Rating Scale Questionnaire
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Intendu and Paper and Pencil cognitive remediation training in people with Affective Disorder, run by Geha Mental Health Center.
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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Gilad Eger, PhD (+972523520180, giladeg1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Observed Tasks of Daily Living - Revised (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2020.