CompletedNot Applicable

CAE for Poorly Adherent Individuals With Schizophrenia

United States36 participantsStarted 2024-01-16

Plain-language summary

This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks

Timeframe: 12 weeks

Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks

Timeframe: 12 weeks

Trial details

NCT IDNCT06061952

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-09

Results submitted2025-09-25

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.