SchizophreniaNCT05352568
Is Cognitive Training an Option?
A study testing Cognitive Training in people with Schizophrenia and Schizoaffective, run by Alliant International University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the feasibility of implementing cognitive training with 40 patients living with schizophrenia and schizoaffective disorder. The study aims to explore if cognitive training as an intervention can improve cognition, symptomology, social cognition, and psychosocial function which… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective, Cognition
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 30 Jun 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- A diagnosis of schizophrenia or schizoaffective disorder
- All genders
- All sexual orientations
- All class/ social-economic status
- All ethnicities
Who cannot join
- An inability to understand the consent process and/or provide assent
- Inability to understand the assent form/process
- Not being a fluent English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
View Heights Convalescent Hospital
Los Angeles, California, 90061
About this study
Official title: Is Cognitive Training an Option? Understanding the Feasibility of Cognitive Training With Individuals Living With Schizophrenia
The purpose of the study is to evaluate the feasibility of implementing cognitive training with 40 patients living with schizophrenia and schizoaffective disorder. The study aims to explore if cognitive training as an intervention can improve cognition, symptomology, social cognition, and psychosocial function which has been determined through literature to be impacted within this population. The results of this study will help shed light on utilizing additional resources to aid in decreasing relapse and continued hospitalizations.
Read the detailed description
After being selected for this study based on a screening survey, participants will be asked to fill out a demographic questionnaire, the Multidimensional Schizotypy Scale - Brief Version (MSS-B), the Montreal Cognitive Assessment (MoCA), the Davos Assessment of Cognitive Biases Scale (DACOBS), and the Illness Management and Recovery Scale - Consumer Self-Rating, IMRS. The measurements evaluate different aspects of severe mental illness which are often challenges. This will take approximately: the screener questionnaire (2-3 minutes), demographic questionnaire (3-5 minutes), MSS-B (38 questions: 10-15 minutes), MoCA (10-15 minutes), DACOBS (42 questions: 15-20 minutes), and IMS (15 questions: 5 to 15 minutes)- Total Maximum Time is 63 minutes. After all, measurements are completed, the participants will be introduced to the BrainHQ program the following week. The participants will begin the selected cognitive training module 3 times a week (Mon, Wed, and Fri), 60 minutes per session for a total of 180 minutes per week. The participants will have a total of 24 sessions over the course of 8 weeks, for a total of 1,440 minutes of cognitive training over the course of this feasibility study. A process questionnaire on the acceptability/ feasibility of the cognitive training program will be administered after the first session, then the middle progress point (4th week), and at the end of the program (8th week) (2-3 minutes). Upon completion of the cognitive training, the participants will retake each measurement (MSS-B, MoCA, DACOBS, and IMRS)-Total Maximum Time is 55 minutes. There is minimal to no risk in this study. Participants will continue their prescribed treatment plan with the addition of the cognitive training which is computerized and takes the form of simulated games with an attended purpose. Participants will continue to be monitored by their providers and staff will continue to evaluate participants for changes in baseline behavior on a daily basis during the course of the study. The plan analysis for this study will be a MANOVA and Correlations. Confidentiality of research records and data will be protected in accordance with the Alliant International University Institutional Review Boards policies, and procedures.
- Conditions
- Schizophrenia, Schizoaffective, Cognition
- Being tested
- Cognitive Training
- Keywords
- Schizophrenia, Schizoaffective, Cognition, Social Cognition, Psychosocial Function
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Computer-Based Cognitive Training from BrainHQ (Posit Science)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Group | Experimental | Computer Cognitive-Based Training Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
A quick screening tool for mild cognitive impairments (MCI) and early Alzheimer's dementia.
Measured: 10-15 minutes
Secondary outcomes (3)
Davos Assessment of Cognitive Biases Scale (DACOBS)
A self-report measure of cognitive biases and cognitive limitations that contributes to psychosis.
Measured: 15-20 minutes
Illness Management and Recovery Scale - Consumer Self-Rating, IMRS
A psychosocial functioning assessment for individuals with schizophrenia.
Measured: 5-15 minutes
Multidimensional Schizotypy Scale - Brief Version (MSS-B)
A symptomology assessment with a subscale consisting of positive, negative, and disorganized dimensions of schizotypy.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start2 May 2022
- Primary completion1 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-test/post-test pre-experimental design with convenience and snowball sampling.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliant International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Pierre Longino, M.A., Alliant International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352568
- Sponsor's protocol ID
- 2105211050
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cognitive Training an Option? Understanding the Feasibility of Cognitive Training With Individuals Living With Schizophrenia
- ClinicalTrials.gov ID
- NCT05352568
- Acronym / sponsor ID
- 2105211050
- Conditions
- Schizophrenia, Schizoaffective, Cognition
- Keywords
- Schizophrenia, Schizoaffective, Cognition, Social Cognition, Psychosocial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alliant International UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Apr 2022 (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 the study is to evaluate the feasibility of implementing cognitive training with 40 patients living with schizophrenia and schizoaffective disorder. The study aims to explore if cognitive training as an intervention can improve cognition, symptomology, social cognition, and psychosocial function which has been determined through literature to be impacted within this population. The results of this study will help shed light on utilizing additional resources to aid in decreasing relapse and continued hospitalizations.
Detailed description
After being selected for this study based on a screening survey, participants will be asked to fill out a demographic questionnaire, the Multidimensional Schizotypy Scale - Brief Version (MSS-B), the Montreal Cognitive Assessment (MoCA), the Davos Assessment of Cognitive Biases Scale (DACOBS), and the Illness Management and Recovery Scale - Consumer Self-Rating, IMRS. The measurements evaluate different aspects of severe mental illness which are often challenges. This will take approximately: the screener questionnaire (2-3 minutes), demographic questionnaire (3-5 minutes), MSS-B (38 questions: 10-15 minutes), MoCA (10-15 minutes), DACOBS (42 questions: 15-20 minutes), and IMS (15 questions: 5 to 15 minutes)- Total Maximum Time is 63 minutes. After all, measurements are completed, the participants will be introduced to the BrainHQ program the following week. The participants will begin the selected cognitive training module 3 times a week (Mon, Wed, and Fri), 60 minutes per session for a total of 180 minutes per week. The participants will have a total of 24 sessions over the course of 8 weeks, for a total of 1,440 minutes of cognitive training over the course of this feasibility study. A process questionnaire on the acceptability/ feasibility of the cognitive training program will be administered after the first session, then the middle progress point (4th week), and at the end of the program (8th week) (2-3 minutes). Upon completion of the cognitive training, the participants will retake each measurement (MSS-B, MoCA, DACOBS, and IMRS)-Total Maximum Time is 55 minutes. There is minimal to no risk in this study. Participants will continue their prescribed treatment plan with the addition of the cognitive training which is computerized and takes the form of simulated games with an attended purpose. Participants will continue to be monitored by their providers and staff will continue to evaluate participants for changes in baseline behavior on a daily basis during the course of the study. The plan analysis for this study will be a MANOVA and Correlations. Confidentiality of research records and data will be protected in accordance with the Alliant International University Institutional Review Boards policies, and procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-test/post-test pre-experimental design with convenience and snowball sampling.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Group | Experimental | Behavioral: Cognitive TrainingComputer Cognitive-Based Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- A diagnosis of schizophrenia or schizoaffective disorder
- All genders
- All sexual orientations
- All class/ social-economic status
Key exclusion criteria (3 listed)
- An inability to understand the consent process and/or provide assent
- Inability to understand the assent form/process
- Not being a fluent English speaker
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 |
|---|---|---|
| Cognitive TrainingComputer-Based Cognitive Training from BrainHQ (Posit Science) | Behavioural | Cognitive Group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 10-15 minutes
A quick screening tool for mild cognitive impairments (MCI) and early Alzheimer's dementia.
3 secondary outcomes
Davos Assessment of Cognitive Biases Scale (DACOBS)
Time frame: 15-20 minutes
Illness Management and Recovery Scale - Consumer Self-Rating, IMRS
Time frame: 5-15 minutes
Multidimensional Schizotypy Scale - Brief Version (MSS-B)
Time frame: 10-15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Schizophrenia and Schizoaffective, run by Alliant International University at 1 site in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 22 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 10-15 minutes). 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 22 Aug 2023.