NCT06061952

CAE for Poorly Adherent Individuals With Schizophrenia

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Customized Adherence Enhancement for Schizophrenia (CAE-S)	6-session series spaced out over approximately 6-10 weeks
OTHER	Enhanced Treatment as Usual (eTAU)	eTAU participants will view a pre-taped series of 6 videos

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-08-09
• Completion: 2025-08-09
• First posted: 2023-09-29
• Last updated: 2025-11-18
• Results posted: 2025-11-18

Locations

1 site across 1 country: United States