Schizophrenia DisorderNCT07488156
Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder
A study testing Educational sessions in people with Schizophrenia Disorder and Schizoaffective Disorder, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder This interventional study is aimed at: assessing and improving the health literacy and assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Disorder, Schizoaffective Disorder, Psychosis
- What is being tested?
- Educational sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Jan 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient behavioral health unit ages 18 and older with a new or previous diagnosis of schizophrenia spectrum disorder outside of substance use disorders
- Patients must be proficient in English.
- Patients must have a government issued social security number (required for reimbursement through the university).
Who cannot join
- Patients at UMCNO that are ages 17 or younger
- Patients with SSD and concomitant intellectual disability, as evidenced by prior documented history on chart review or patients suspected to have intellectual disability or impairment based on clinical interactions
- Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications
- Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization
- Patients that are not proficient in English
- Patients that do not have a government issued social security number
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 Medical Center
New Orleans, Louisiana, 70112
Jaudé Petrie, MD, 504-702-3000, jpetri@lsuhsc.edu
Jaudé Petrie, MD
About this study
Official title: The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder
The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder
This interventional study is aimed at:
- assessing and improving the health literacy and
- assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.
Read the detailed description
The study will take place at University Medical Center in New Orleans, LA and will include 34 patients with a schizophrenia spectrum disorder diagnosis who are admitted to the psychiatric unit. Participants will take tests to assess their knowledge of SSD before and after receiving educational materials during their hospitalization. They will also receive questionnaires assessing their attitudes toward treatment before and after the educational interventions. After each patient is provided with educational material, they will be allowed to ask the healthcare provider questions pertaining to schizophrenia. Following discharge, patients will be followed for a total of 12 months, where they will be called to answer questions about medication adherence.
- Conditions
- Schizophrenia Disorder, Schizoaffective Disorder, Psychosis
- Being tested
- Educational sessions
- Keywords
- Educational interventions, Schizophrenia, Schizophrenia spectrum disorders, Health literacy
- 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.
Educational sessionsBehavioural
Patients will be given an educational pamphlet with information about schizophrenia spectrum disorders, including prognosis and management options. Following this, they will be allowed to ask the doctor any questions they have pertaining to schizophrenia spectrum disorder. In the second educational session, patients will watch a video containing information about schizophrenia spectrum disorders. Following this, they will be allowed to ask the doctor any questions they have pertaining to this topic.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosis | Experimental | Patients will be exposed to educational materials in the form of a pamphlet and a video Receives: Behavioral: Educational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention KAST (Knowledge About Schizophrenia Test) scores
This includes an 18-item multiple choice test, with only one correct answer for each item. Scores range from 0 to 100%. Higher scores indicate a higher level of knowledge.
Measured: This will be collected on Day 5 of the study, after the participant has completed both educational sessions.
Post-intervention ATT (Attitudes Toward Treatment) scores
This test includes a total of 20 questions, each ranging from 0 to 10 points. Total score ranges from 0 to 200 points. Higher scores indicate a more favorable attitude towards medications.
Measured: This will be collected on Day 5 of the study, after the participant has completed both educational sessions.
Secondary outcomes (1)
MARS (Medication Adherence Rating Scale) scores
This is a 10-item questionnaire with only yes and no answer choices. Participants will be given 0 points for answers that represent poor adherence and they will be given 10 points for answers that represent good adherence. Scores will range from 0 to 100 points, with higher scores indicating more adherence.
Measured: This questionnaire will be given on a monthly basis in the follow up period, for a total of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488156
- Sponsor's protocol ID
- 8277
- Other IDs
- R076477SCH4075
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.
PubMed 31823381Kampman O, Lehtinen K, Lassila V, Leinonen E, Poutanen O, Koivisto A. Attitudes towards neuroleptic treatment: reliability and validity of the attitudes towards neuroleptic treatment (ANT) questionnaire. Schizophr Res. 2000 Oct 27;45(3):223-34. doi: 10.1016/s0920-9964(99)00204-2.
PubMed 11042440Chan KW, Hui LM, Wong HY, Lee HM, Chang WC, Chen YH. Medication adherence, knowledge about psychosis, and insight among patients with a schizophrenia-spectrum disorder. J Nerv Ment Dis. 2014 Jan;202(1):25-9. doi: 10.1097/NMD.0000000000000068.
PubMed 24375208von dem Knesebeck O, Mnich E, Daubmann A, Wegscheider K, Angermeyer MC, Lambert M, Karow A, Harter M, Kofahl C. Socioeconomic status and beliefs about depression, schizophrenia and eating disorders. Soc Psychiatry Psychiatr Epidemiol. 2013 May;48(5):775-82. doi: 10.1007/s00127-012-0599-1. Epub 2012 Oct 10.
PubMed 23052428Tsai KY, Chung TC, Lee CC, Chou YM, Su CY, Shen SP, Lin CH, Chou FH. Is low individual socioeconomic status (SES) in high-SES areas the same as low individual SES in low-SES areas: a 10-year follow-up schizophrenia study. Soc Psychiatry Psychiatr Epidemiol. 2014 Jan;49(1):89-96. doi: 10.1007/s00127-013-0716-9. Epub 2013 Jun 2.
PubMed 23728232Sharp HC. Vasectomy as a means of preventing procreation in defectives. J Am Med Assoc. 1909 Dec 4;53(23):1897-902. doi: 10.1001/jama.1909.92550230009002e.
PubMed 12334406Freimuth VS, Quinn SC, Thomas SB, Cole G, Zook E, Duncan T. African Americans' views on research and the Tuskegee Syphilis Study. Soc Sci Med. 2001 Mar;52(5):797-808. doi: 10.1016/s0277-9536(00)00178-7.
PubMed 11218181Hamilton LA, Aliyu MH, Lyons PD, May R, Swanson CL Jr, Savage R, Go RC. African-American community attitudes and perceptions toward schizophrenia and medical research: an exploratory study. J Natl Med Assoc. 2006 Jan;98(1):18-27.
PubMed 16532974Cheng HL, Kwan KL, Sevig T. Racial and ethnic minority college students' stigma associated with seeking psychological help: Examining psychocultural correlates. J Couns Psychol. 2013 Jan;60(1):98-111. doi: 10.1037/a0031169.
PubMed 23356468Gara MA, Minsky S, Silverstein SM, Miskimen T, Strakowski SM. A Naturalistic Study of Racial Disparities in Diagnoses at an Outpatient Behavioral Health Clinic. Psychiatr Serv. 2019 Feb 1;70(2):130-134. doi: 10.1176/appi.ps.201800223. Epub 2018 Dec 10.
PubMed 30526340van Hooijdonk CFM, van der Pluijm M, Bosch I, van Amelsvoort TAMJ, Booij J, de Haan L, Selten JP, Giessen EV. The substantia nigra in the pathology of schizophrenia: A review on post-mortem and molecular imaging findings. Eur Neuropsychopharmacol. 2023 Mar;68:57-77. doi: 10.1016/j.euroneuro.2022.12.008. Epub 2023 Jan 12.
PubMed 36640734Alegria M, Chatterji P, Wells K, Cao Z, Chen CN, Takeuchi D, Jackson J, Meng XL. Disparity in depression treatment among racial and ethnic minority populations in the United States. Psychiatr Serv. 2008 Nov;59(11):1264-72. doi: 10.1176/ps.2008.59.11.1264.
PubMed 18971402Coleman KJ, Stewart C, Waitzfelder BE, Zeber JE, Morales LS, Ahmed AT, Ahmedani BK, Beck A, Copeland LA, Cummings JR, Hunkeler EM, Lindberg NM, Lynch F, Lu CY, Owen-Smith AA, Trinacty CM, Whitebird RR, Simon GE. Racial-Ethnic Differences in Psychiatric Diagnoses and Treatment Across 11 Health Care Systems in the Mental Health Research Network. Psychiatr Serv. 2016 Jul 1;67(7):749-57. doi: 10.1176/appi.ps.201500217. Epub 2016 Apr 15.
PubMed 27079987
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07488156
- Acronym / sponsor ID
- 8277
- Conditions
- Schizophrenia Disorder, Schizoaffective Disorder, Psychosis
- Keywords
- Educational interventions, Schizophrenia, Schizophrenia spectrum disorders, Health literacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Mar 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 Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder
This interventional study is aimed at:
- assessing and improving the health literacy and
- assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.
Detailed description
The study will take place at University Medical Center in New Orleans, LA and will include 34 patients with a schizophrenia spectrum disorder diagnosis who are admitted to the psychiatric unit. Participants will take tests to assess their knowledge of SSD before and after receiving educational materials during their hospitalization. They will also receive questionnaires assessing their attitudes toward treatment before and after the educational interventions. After each patient is provided with educational material, they will be allowed to ask the healthcare provider questions pertaining to schizophrenia. Following discharge, patients will be followed for a total of 12 months, where they will be called to answer questions about medication adherence.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosis | Experimental | Behavioral: Educational sessionsPatients will be exposed to educational materials in the form of a pamphlet and a video |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient behavioral health unit ages 18 and older with a new or previous diagnosis of schizophrenia spectrum disorder outside of substance use disorders
- Patients must be proficient in English.
- Patients must have a government issued social security number (required for reimbursement through the university).
Key exclusion criteria (6 listed)
- Patients at UMCNO that are ages 17 or younger
- Patients with SSD and concomitant intellectual disability, as evidenced by prior documented history on chart review or patients suspected to have intellectual disability or impairment based on clinical interactions
- Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications
- Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization
- Patients that are not proficient in English
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 |
|---|---|---|
| Educational sessionsPatients will be given an educational pamphlet with information about schizophrenia spectrum disorders, including prognosis and management options. Following this, they will be allowed to ask the doctor any questions they have pertaining to schizophrenia spectrum disorder. In the second educational session, patients will watch a video containing information about schizophrenia spectrum disorders. Following this, they will be allowed to ask the doctor any questions they have pertaining to this topic. | Behavioural | Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosis |
Primary outcome
Post-intervention KAST (Knowledge About Schizophrenia Test) scores
Time frame: This will be collected on Day 5 of the study, after the participant has completed both educational sessions.
This includes an 18-item multiple choice test, with only one correct answer for each item. Scores range from 0 to 100%. Higher scores indicate a higher level of knowledge.
Post-intervention ATT (Attitudes Toward Treatment) scores
Time frame: This will be collected on Day 5 of the study, after the participant has completed both educational sessions.
This test includes a total of 20 questions, each ranging from 0 to 10 points. Total score ranges from 0 to 200 points. Higher scores indicate a more favorable attitude towards medications.
1 secondary outcome
MARS (Medication Adherence Rating Scale) scores
Time frame: This questionnaire will be given on a monthly basis in the follow up period, for a total of 12 months.
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 23 Mar 2026.
- Background: PubMed 31823381Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.
- Background: PubMed 11042440Kampman O, Lehtinen K, Lassila V, Leinonen E, Poutanen O, Koivisto A. Attitudes towards neuroleptic treatment: reliability and validity of the attitudes towards neuroleptic treatment (ANT) questionnaire. Schizophr Res. 2000 Oct 27;45(3):223-34. doi: 10.1016/s0920-9964(99)00204-2.
- Background: PubMed 24375208Chan KW, Hui LM, Wong HY, Lee HM, Chang WC, Chen YH. Medication adherence, knowledge about psychosis, and insight among patients with a schizophrenia-spectrum disorder. J Nerv Ment Dis. 2014 Jan;202(1):25-9. doi: 10.1097/NMD.0000000000000068.
- Background: PubMed 23052428von dem Knesebeck O, Mnich E, Daubmann A, Wegscheider K, Angermeyer MC, Lambert M, Karow A, Harter M, Kofahl C. Socioeconomic status and beliefs about depression, schizophrenia and eating disorders. Soc Psychiatry Psychiatr Epidemiol. 2013 May;48(5):775-82. doi: 10.1007/s00127-012-0599-1. Epub 2012 Oct 10.
- Background: PubMed 23728232Tsai KY, Chung TC, Lee CC, Chou YM, Su CY, Shen SP, Lin CH, Chou FH. Is low individual socioeconomic status (SES) in high-SES areas the same as low individual SES in low-SES areas: a 10-year follow-up schizophrenia study. Soc Psychiatry Psychiatr Epidemiol. 2014 Jan;49(1):89-96. doi: 10.1007/s00127-013-0716-9. Epub 2013 Jun 2.
- Background: PubMed 12334406Sharp HC. Vasectomy as a means of preventing procreation in defectives. J Am Med Assoc. 1909 Dec 4;53(23):1897-902. doi: 10.1001/jama.1909.92550230009002e.
- Background: PubMed 11218181Freimuth VS, Quinn SC, Thomas SB, Cole G, Zook E, Duncan T. African Americans' views on research and the Tuskegee Syphilis Study. Soc Sci Med. 2001 Mar;52(5):797-808. doi: 10.1016/s0277-9536(00)00178-7.
- Background: PubMed 16532974Hamilton LA, Aliyu MH, Lyons PD, May R, Swanson CL Jr, Savage R, Go RC. African-American community attitudes and perceptions toward schizophrenia and medical research: an exploratory study. J Natl Med Assoc. 2006 Jan;98(1):18-27.
- Background: PubMed 23356468Cheng HL, Kwan KL, Sevig T. Racial and ethnic minority college students' stigma associated with seeking psychological help: Examining psychocultural correlates. J Couns Psychol. 2013 Jan;60(1):98-111. doi: 10.1037/a0031169.
- Background: PubMed 30526340Gara MA, Minsky S, Silverstein SM, Miskimen T, Strakowski SM. A Naturalistic Study of Racial Disparities in Diagnoses at an Outpatient Behavioral Health Clinic. Psychiatr Serv. 2019 Feb 1;70(2):130-134. doi: 10.1176/appi.ps.201800223. Epub 2018 Dec 10.
- Background: PubMed 36640734van Hooijdonk CFM, van der Pluijm M, Bosch I, van Amelsvoort TAMJ, Booij J, de Haan L, Selten JP, Giessen EV. The substantia nigra in the pathology of schizophrenia: A review on post-mortem and molecular imaging findings. Eur Neuropsychopharmacol. 2023 Mar;68:57-77. doi: 10.1016/j.euroneuro.2022.12.008. Epub 2023 Jan 12.
- Background: PubMed 18971402Alegria M, Chatterji P, Wells K, Cao Z, Chen CN, Takeuchi D, Jackson J, Meng XL. Disparity in depression treatment among racial and ethnic minority populations in the United States. Psychiatr Serv. 2008 Nov;59(11):1264-72. doi: 10.1176/ps.2008.59.11.1264.
- Institute of Health Metrics and Evaluation. Global Health Data ExchangeLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational sessions in people with Schizophrenia Disorder and Schizoaffective Disorder, run by Louisiana State University Health Sciences Center in New Orleans 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 3 inclusion and 6 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 23 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention KAST (Knowledge About Schizophrenia Test) scores (time frame: This will be collected on Day 5 of the study, after the participant has completed both educational sessions.). 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?
On the ClinicalTrials.gov record for NCT07488156, which also lists 13 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 23 Mar 2026.