Schizophrenia / Schizoaffective DisorderPhase 1/2NCT07674914
A Cognitive Mobile Intervention for Motivation in Psychotic Disorders
A Phase 1/2 study testing Cognitive Training and Mobile cognitive training in people with Schizophrenia / Schizoaffective Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this study is to develop and test the impact of a smartphone-based working memory cognitive training digital therapeutic for individuals with schizophrenia or a related disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia / Schizoaffective Disorder
- What is being tested?
- Cognitive Training and Mobile cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- diagnosis of schizophrenia, schizoaffective disorder, or a related psychotic disorder
- own a smartphone
- English speaking
- experiencing challenges with cognitive functioning
- no changes to antipsychotic medication in past month
Who cannot join
- history of neurological disorder
- traumatic brain injury with loss of consciousness > 10 minutes or behavioral sequelae.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Lauren Luther, Ph.D., 205-530-1117, CAS-treatlab@uab.edu
Lauren Luther, PhD
About this study
Official title: A User-Informed Digital Therapeutic for Specific Cognitive Disabilities to Improve Mental Health in Schizophrenia and Related Mental Illnesses
The goal of this study is to develop and test the impact of a smartphone-based working memory cognitive training digital therapeutic for individuals with schizophrenia or a related disorder.
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Being tested
- Cognitive Training, Mobile cognitive training
- Keywords
- schizophrenia, psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
This will be a digital cognitive training program.
Mobile cognitive trainingBehavioural
This will be a remotely delivered mobile cognitive intervention via a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| cognitive intervention | Experimental | Not described Receives: Behavioral: Cognitive Training; Behavioral: Mobile cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number correct in letter number span working memory test
Full scale of 24 items
Measured: Day 1 and Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia / Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- UAB CEDHARS
- Responsible party
- Principal investigator, Lauren Luther, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674914
- Sponsor's protocol ID
- IRB-300016943
- Other IDs
- UAB's CEDHARS
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A User-Informed Digital Therapeutic for Specific Cognitive Disabilities to Improve Mental Health in Schizophrenia and Related Mental Illnesses
- ClinicalTrials.gov ID
- NCT07674914
- Acronym / sponsor ID
- IRB-300016943
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Keywords
- schizophrenia, psychosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- UAB CEDHARS
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Jun 2026 (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 goal of this study is to develop and test the impact of a smartphone-based working memory cognitive training digital therapeutic for individuals with schizophrenia or a related disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive intervention | Experimental | Behavioral: Cognitive Training, Behavioral: Mobile cognitive training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia, schizoaffective disorder, or a related psychotic disorder
- own a smartphone
- English speaking
- experiencing challenges with cognitive functioning
- no changes to antipsychotic medication in past month
Key exclusion criteria (2 listed)
- history of neurological disorder
- traumatic brain injury with loss of consciousness > 10 minutes or behavioral sequelae.
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 TrainingThis will be a digital cognitive training program. | Behavioural | cognitive intervention |
| Mobile cognitive trainingThis will be a remotely delivered mobile cognitive intervention via a smartphone application. | Behavioural | cognitive intervention |
Primary outcome
Change in number correct in letter number span working memory test
Time frame: Day 1 and Day 16
Full scale of 24 items
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Training and Mobile cognitive training in people with Schizophrenia / Schizoaffective Disorder, run by University of Alabama at Birmingham 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Jun 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Luther, PhD (205-530-1117, CAS-treatlab@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number correct in letter number span working memory test (time frame: Day 1 and Day 16). 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 30 Jun 2026.