Trial results for a study investigating remotely delivered Customized Adherence Enhancement for Schizophrenia (CAE-S) were posted on ClinicalTrials.gov on 2025-11-18, indicating that 93.8% of participants found the intervention useful.
Background
Schizophrenia is a chronic and severe mental disorder that significantly impacts an individual's thoughts, feelings, and behaviors. A critical challenge in managing schizophrenia is ensuring consistent adherence to prescribed medication and treatment plans, as poor adherence can lead to symptom relapse and worse health outcomes. Innovations that can improve treatment adherence, particularly through remote delivery methods, are crucial for enhancing patient care and supporting long-term stability. This study aimed to explore the feasibility and impact of such a remote adherence enhancement program.
Trial design
This completed study, identified as Phase NA, enrolled 36 participants with Schizophrenia. The project aimed to evaluate the feasibility, acceptability, and preliminary efficacy of remotely delivered Customized Adherence Enhancement for Schizophrenia (CAE-S). Participants were assigned to either the CAE-S intervention group or an Enhanced Treatment as Usual (eTAU) group.
Key results
The trial results highlighted several key measurements regarding the intervention's feasibility, acceptability, and preliminary efficacy:
- Acceptability of the CAE-S intervention was high, with 93.8% of subjects in the CAE-S group agreeing or strongly agreeing that the intervention was useful at 12 weeks.
- Participants in the CAE-S group attended an average of 4.89 sessions (Standard Deviation 1.9) over 12 weeks.
- For the Positive and Negative Syndrome Scale (PANSS) Total Score, the CAE-S group had a mean score of 60.9 (Standard Deviation 10.5) at baseline and 53.8 (Standard Deviation 9.0) at 12 weeks. The eTAU group had a mean score of 66.0 (Standard Deviation 9.7) at baseline and 54.2 (Standard Deviation 11.2) at 12 weeks.
- Regarding the Tablets Routine Questionnaire (TRQ) in the past 7 days, which measures the percentage of days with missed doses, the CAE-S group showed a mean of 13.4% (Standard Deviation 16.5) at baseline and 17.9% (Standard Deviation 28.0) at 12 weeks. The eTAU group showed a mean of 13.2% (Standard Deviation 10.9) at baseline and 8.8% (Standard Deviation 11.0) at 12 weeks.
- For the TRQ in the past 30 days, the CAE-S group showed a mean of 11.9% (Standard Deviation 20.7) at 12 weeks, while the eTAU group showed a mean of 7.7% (Standard Deviation 8.6) at 12 weeks.
What this means
The high acceptability rate of 93.8% suggests that remotely delivered Customized Adherence Enhancement for Schizophrenia (CAE-S) is well-received by individuals with the condition. This is a positive indicator for the feasibility of implementing such an intervention in clinical practice. While both the CAE-S and eTAU groups showed a decrease in PANSS scores, suggesting some improvement in symptoms, the adherence data from the Tablets Routine Questionnaire (TRQ) presented mixed or less favorable trends for the CAE-S group compared to eTAU, particularly for the 7-day recall. Given the small enrollment of 36 participants, these findings are preliminary. However, the strong acceptability supports further investigation into remote adherence interventions for schizophrenia, potentially with modifications to enhance actual adherence outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06061952, titled "CAE for Poorly Adherent Individuals With Schizophrenia", were posted on 2025-11-18 on clinicaltrials.gov.