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Behavioral Intervention

Online Therapy for Schizophrenia (CAE-S Trial)

N/A
Recruiting
Led By Martha Sajatovic, MD
Research Sponsored by Martha Sajatovic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
Prescribed an antipsychotic medication for treatment of schizophrenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

CAE-S Trial Summary

This trial will assess if online therapy can help people with schizophrenia manage their symptoms.

Who is the study for?
This trial is for adults with schizophrenia known to have issues taking their medication regularly. They must be receiving or scheduled for treatment at a mental health clinic, able to consent, have internet access and an electronic device for videoconferencing sessions, and be on antipsychotic meds. Excluded are those treated with clozapine, pregnant or breastfeeding women, individuals at immediate risk of harm to self or others, those without internet access or device for the study's remote sessions, and anyone physically dependent on substances.Check my eligibility
What is being tested?
The trial is testing a remotely delivered program called Customized Adherence Enhancement (CAE-S) against Enhanced Treatment as Usual (eTAU) in people with schizophrenia who struggle with sticking to their medication regimen. The goal is to see if CAE-S can help improve how well patients follow their treatment plans when it's done through video calls.See study design
What are the potential side effects?
Since this trial focuses on adherence enhancement rather than a specific drug intervention, side effects may not be directly related to the CAE-S program but could include typical reactions associated with ongoing antipsychotic medications such as drowsiness, weight gain, dry mouth, restlessness or tremors.

CAE-S Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and have been diagnosed with schizophrenia.
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I am taking medication for schizophrenia.
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I am currently getting or will get mental health care at a clinic.

CAE-S Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average number of CAE sessions attended by those in the CAE group after 12 weeks
Percentage of subjects in the CAE group that agree or strongly agree that the intervention was useful at 12 weeks
Secondary outcome measures
Change in Positive and Negative Syndrome Scale (PANSS) total score between CAE-S and eTAU groups at 12 weeks
Change in Tablets Routine Questionnaire (TRQ) at 12 weeks
Change in eCAP use at 12 weeks

CAE-S Trial Design

2Treatment groups
Experimental Treatment
Group I: Enhanced Treatment as Usual (eTAU)Experimental Treatment1 Intervention
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.
Group II: Customized Adherence Enhancement for Schizophrenia (CAE-S)Experimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Martha SajatovicLead Sponsor
2 Previous Clinical Trials
73 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,535 Total Patients Enrolled
23 Trials studying Schizophrenia
2,650 Patients Enrolled for Schizophrenia
Martha Sajatovic, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
20 Previous Clinical Trials
1,530 Total Patients Enrolled
5 Trials studying Schizophrenia
330 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being recruited for this research project?

"According to information hosted on clinicaltrials.gov, this specific medical trial is no longer recruiting patients as it was last updated on September 25th 2023. Nonetheless, 355 other trials are currently seeking participants at present."

Answered by AI
~24 spots leftby Apr 2025