CAE for Poorly Adherent Individuals With Schizophrenia

NCT06061952 | Completed Results

• 1 other identifier: STUDY20230135
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 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

  12 weeks

Secondary Outcomes (4)

• Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks

  12 weeks

• Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks

  12 weeks

• Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks

  12 weeks

• Change in eCAP Use in the Past Week at 12 Weeks

  12 weeks

Study Arms (2)

Customized Adherence Enhancement for Schizophrenia (CAE-S)

EXPERIMENTAL

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)

Enhanced Treatment as Usual (eTAU)

OTHER

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)

Interventions

Customized Adherence Enhancement for Schizophrenia (CAE-S) BEHAVIORAL

6-session series spaced out over approximately 6-10 weeks

Customized Adherence Enhancement for Schizophrenia (CAE-S)

Enhanced Treatment as Usual (eTAU) OTHER

eTAU participants will view a pre-taped series of 6 videos

Enhanced Treatment as Usual (eTAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Martha Sajatovic, MD
• Organization: University Hospitals Cleveland Medical Center

martha.sajatovic@UHHospitals.org

216-844-2808

Study Officials

• Martha Sajatovic, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, UHMG

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: January 16, 2024
• Primary Completion: August 9, 2025
• Study Completion: August 9, 2025
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)