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NCT06061952Completed

CAE for Poorly Adherent Individuals With Schizophrenia

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)

Source: ClinicalTrials.gov · Last updated 18 Nov 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
36 (actual)
First submitted
25 Sept 2023
Start date
16 Jan 2024
Primary completion date
9 Aug 2025
Lead sponsor
University Hospitals Cleveland Medical Center
NCT number
NCT06061952

What you commit to

  • Study type: Interventional
  • Participants enrolled: 36
  • From 16 Jan 2024 to the primary completion date, 9 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
  • 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

Other illness

  • Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial

Other

  • Immediate risk of harm to self or others
  • Female who is currently pregnant or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.