COMPLETED

CAE for Poorly Adherent Individuals With Schizophrenia

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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)

Quick Facts

Study Start:2024-01-16
Study Completion:2025-08-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06061952

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
  2. * Prescribed an antipsychotic medication for treatment of schizophrenia
  3. * 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)
  4. * Ability to be rated on psychiatric rating scales
  5. * 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
  6. * Able to provide written, informed consent to study participation
  7. * Has access to electronic device and internet to complete sessions conducted on videoconferencing platform
  1. * Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
  2. * Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
  3. * 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
  4. * Immediate risk of harm to self or others
  5. * Female who is currently pregnant or breastfeeding

Contacts and Locations

Principal Investigator

Martha Sajatovic, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Martha Sajatovic, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-01-16
Study Completion Date2025-08-09

Study Record Updates

Study Start Date2024-01-16
Study Completion Date2025-08-09

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia