SchizophreniaCAE-SNCT06061952
CAE for Poorly Adherent Individuals With Schizophrenia
A study testing Customized Adherence Enhancement for Schizophrenia (CAE-S) and Enhanced Treatment as Usual (eTAU) in people with Schizophrenia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Customized Adherence Enhancement for Schizophrenia (CAE-S) and Enhanced Treatment as Usual (eTAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 9 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
- Prescribed an antipsychotic medication for treatment of schizophrenia
- Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month)
- Ability to be rated on psychiatric rating scales
- Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation
- Able to provide written, informed consent to study participation
- Has access to electronic device and internet to complete sessions conducted on videoconferencing platform
Who cannot join
- Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
- Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
- Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
- Immediate risk of harm to self or others
- Female who is currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Prospective 12-week Randomized Controlled Trial (RCT) of Remotely- Delivered Customized Adherence Enhancement for Poorly Adherent Individuals With Schizophrenia (CAE-S) vs Enhanced Treatment as Usual (eTAU)
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Read the detailed description
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.
- Conditions
- Schizophrenia
- Being tested
- Customized Adherence Enhancement for Schizophrenia (CAE-S), Enhanced Treatment as Usual (eTAU)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized Adherence Enhancement for Schizophrenia (CAE-S)Behavioural
6-session series spaced out over approximately 6-10 weeks
Enhanced Treatment as Usual (eTAU)Other
eTAU participants will view a pre-taped series of 6 videos
| Study group | Role | What they receive |
|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Experimental | CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use. Receives: Behavioral: Customized Adherence Enhancement for Schizophrenia (CAE-S) |
| Enhanced Treatment as Usual (eTAU) | Other | To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have. Receives: Other: Enhanced Treatment as Usual (eTAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks
Measured: 12 weeks
Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks
Measured: 12 weeks
Secondary outcomes (4)
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks
The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia
Measured: 12 weeks
Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.
Measured: 12 weeks
Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.
Measured: 12 weeks
Change in eCAP Use in the Past Week at 12 Weeks
Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start16 Jan 2024
- Primary completion9 Aug 2025
- Study completion9 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Martha Sajatovic, University Hospitals Cleveland Medical Center
- Investigators
- Martha Sajatovic, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061952
- Sponsor's protocol ID
- STUDY20230135
- Acronym
- CAE-S
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2023
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective 12-week Randomized Controlled Trial (RCT) of Remotely- Delivered Customized Adherence Enhancement for Poorly Adherent Individuals With Schizophrenia (CAE-S) vs Enhanced Treatment as Usual (eTAU)
- ClinicalTrials.gov ID
- NCT06061952
- Acronym / sponsor ID
- CAE-S / STUDY20230135
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 9 Aug 2025 (actual)
- Study completion
- 9 Aug 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Detailed description
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Experimental | Behavioral: Customized Adherence Enhancement for Schizophrenia (CAE-S)CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use. |
| Enhanced Treatment as Usual (eTAU) | Other | Other: Enhanced Treatment as Usual (eTAU)To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
- Prescribed an antipsychotic medication for treatment of schizophrenia
- Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month)
- Ability to be rated on psychiatric rating scales
- Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation
Key exclusion criteria (5 listed)
- Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
- Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
- Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
- Immediate risk of harm to self or others
- Female who is currently pregnant or breastfeeding
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 |
|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S)6-session series spaced out over approximately 6-10 weeks | Behavioural | Customized Adherence Enhancement for Schizophrenia (CAE-S) |
| Enhanced Treatment as Usual (eTAU)eTAU participants will view a pre-taped series of 6 videos | Other | Enhanced Treatment as Usual (eTAU) |
Primary outcome
Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks
Time frame: 12 weeks
Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks
Time frame: 12 weeks
4 secondary outcomes
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks
Time frame: 12 weeks
Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks
Time frame: 12 weeks
Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks
Time frame: 12 weeks
Change in eCAP Use in the Past Week at 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Martha Sajatovic, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized Adherence Enhancement for Schizophrenia (CAE-S) and Enhanced Treatment as Usual (eTAU) in people with Schizophrenia, run by University Hospitals Cleveland Medical Center 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 7 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: finished, as of the sponsor's last update on 18 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks (time frame: 12 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 18 Nov 2025.