CAE for Poorly Adherent Individuals With Schizophrenia (CAE-S)

November 3, 2025 updated by: Martha Sajatovic, University Hospitals Cleveland Medical Center

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Customized Adherence Enhancement for Schizophrenia (CAE-S)
6-session series spaced out over approximately 6-10 weeks
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.
Other: Enhanced Treatment as Usual (eTAU)
eTAU participants will view a pre-taped series of 6 videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks
Time Frame: 12 weeks
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks
Time Frame: 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
12 weeks
Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks
Time Frame: 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.
12 weeks
Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks
Time Frame: 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.
12 weeks
Change in eCAP Use in the Past Week at 12 Weeks
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Martha Sajatovic, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Actual)

August 9, 2025

Study Completion (Actual)

August 9, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20230135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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