Skip to main content
OpenTrials
Completed

NCT Number: NCT06061952

CAE for Poorly Adherent Individuals With Schizophrenia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Customized Adherence Enhancement for Schizophrenia (CAE-S)

Behavioral

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

Primary outcomes

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

    Time frame: 12 weeks

  2. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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)

Acronym: CAE-S

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.