CAE for Poorly Adherent Individuals With Schizophrenia

Last updated: June 2, 2025
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

Customized Adherence Enhancement for Schizophrenia (CAE-S)

Enhanced Treatment as Usual (eTAU)

Clinical Study ID

NCT06061952
STUDY20230135
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals age 18 and older with schizophrenia as confirmed by the MiniInternational Psychiatric Inventory (MINI)

  • Prescribed an antipsychotic medication for treatment of schizophrenia

  • Known to have medication treatment adherence problems as identified by the TabletsRoutine Questionnaire (TRQ, 20% or more missed medications in past week or pastmonth)

  • Ability to be rated on psychiatric rating scales

  • Currently in treatment or scheduled to receive treatment at a Community MentalHealth Clinic (CMHC) or other clinical setting able to provide mental health careduring and after study participation

  • Able to provide written, informed consent to study participation

  • Has access to electronic device and internet to complete sessions conducted onvideoconferencing platform

Exclusion

Exclusion Criteria:

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

  • 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 towithdrawal reaction during the course of the study in the clinical opinion of thetreated research psychiatrist

  • Immediate risk of harm to self or others

  • Female who is currently pregnant or breastfeeding

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Customized Adherence Enhancement for Schizophrenia (CAE-S)
Phase:
Study Start date:
January 16, 2024
Estimated Completion Date:
August 15, 2025

Study 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.

Connect with a study center

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.