N/A
Completed N=36
CAE for Poorly Adherent Individuals With Schizophrenia
Source: ClinicalTrials.gov NCT06061952 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Nov 2025
Primary outcomePrimary: Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks — 4.89 Number of sessions attended
Summary
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks |
4.89 | — |
| PRIMARY Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks |
93.8 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks |
60.9; 66.0; 53.8; 54.2 | — |
| SECONDARY Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks |
13.4; 13.2; 17.9; 8.8 | — |
| SECONDARY Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks |
11.9; 7.7; 7.4; 5.4 | — |
| SECONDARY Change in eCAP Use in the Past Week at 12 Weeks |
20.8; 32.1; 33.8; 50 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06061952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.