CAE for Poorly Adherent Individuals With Schizophrenia

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT06061952
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 16, 2024
Status verified
Nov 2025
Primary completion
Aug 9, 2025
Completion
Aug 9, 2025

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Customized Adherence Enhancement for Schizophrenia (CAE-S)
    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.
  • Other: Enhanced Treatment as Usual (eTAU)
    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.

Primary Outcome Measure

Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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