Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2024-01-16
2025-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Customized Adherence Enhancement for Schizophrenia (CAE-S)
6-session series spaced out over approximately 6-10 weeks
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.
Enhanced Treatment as Usual (eTAU)
eTAU participants will view a pre-taped series of 6 videos
Interventions
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Customized Adherence Enhancement for Schizophrenia (CAE-S)
6-session series spaced out over approximately 6-10 weeks
Enhanced Treatment as Usual (eTAU)
eTAU participants will view a pre-taped series of 6 videos
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Martha Sajatovic
Physician, UHMG
Principal Investigators
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Martha Sajatovic, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY20230135
Identifier Type: -
Identifier Source: org_study_id
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