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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

Must not have

Female who is currently pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met