Online Therapy for Schizophrenia

(CAE-S Trial)

Overseen By Gracie Howard-Griggs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Martha Sajatovic

Must be taking: Antipsychotics

Must not be taking: Clozapine

Disqualifiers: Substance dependence, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called Customized Adherence Enhancement for Schizophrenia (CAE-S). The goal is to determine its effectiveness in helping people with schizophrenia adhere to their medication routines through virtual sessions. Participants will learn about medication habits, communication with healthcare providers, and substance use. This trial suits adults with schizophrenia who struggle with regular medication intake and have internet access for video sessions. As an unphased trial, it provides a unique opportunity to explore innovative methods for improving medication adherence.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be on an antipsychotic medication for schizophrenia. If you are on clozapine, you cannot participate in this trial.

What prior data suggests that this online therapy is safe for patients with schizophrenia?

Research shows that Customized Adherence Enhancement (CAE) treatments, such as the one tested for schizophrenia, are generally safe. Studies have found these treatments are usually well-tolerated, with few serious side effects. For instance, a previous trial reported only one serious issue among 19 participants in a similar CAE program. Other studies have examined body weight, vital signs, and lab tests to ensure safety, finding no major concerns.

Overall, existing research suggests that CAE is a safe option for those considering this type of support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Customized Adherence Enhancement for Schizophrenia (CAE-S) because it offers a unique approach to supporting individuals with schizophrenia through virtual, personalized therapy. Unlike standard treatments that primarily focus on medication, CAE-S provides an adjunctive behavioral intervention delivered via one-on-one video conferencing. It emphasizes four key modules: Psychoeducation, Communication with Providers, Medication Routines, and Substance Use, aiming to enhance adherence to treatment regimens. This method could empower patients by providing them with tailored strategies and ongoing support, potentially leading to better treatment outcomes and improved quality of life.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research shows that the Customized Adherence Enhancement for Schizophrenia (CAE-S) program, a treatment arm in this trial, may help people with schizophrenia take their medication more regularly and reduce symptoms. Studies have found that similar programs improve medication habits, daily functioning, and symptoms in individuals with schizophrenia or schizoaffective disorder. These programs have been particularly beneficial for those who are homeless or have recently experienced homelessness. The CAE-S program includes sessions on learning about the condition and communicating with healthcare providers, conducted through live video calls. These sessions aim to help patients manage medication schedules and address substance use issues. Early evidence suggests that CAE-S can effectively manage schizophrenia. Meanwhile, another treatment arm in this trial, Enhanced Treatment as Usual (eTAU), involves participants viewing a pre-taped series of wellness videos with a therapist to optimize control intervention rigor. ^{2 3 4 6 7}

Who Is on the Research Team?

Martha Sajatovic, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Has access to electronic device and internet to complete sessions conducted on videoconferencing platform

I am 18 or older and have been diagnosed with schizophrenia.

I am taking medication for schizophrenia.

Exclusion Criteria

I am currently pregnant or breastfeeding.

I am currently taking or have taken clozapine.

Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment before randomization

1 week

Treatment

Participants receive either CAE-S or eTAU intervention over 6-10 weeks

12 weeks

6 virtual sessions

Follow-up

Participants are monitored for changes in schizophrenia symptoms and medication adherence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Enhanced Treatment as Usual (eTAU) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Martha Sajatovic

Lead Sponsor

Trials

3

Recruited

110+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The Customized Adherence Enhancement (CAE) program significantly improved medication adherence in 43 individuals with bipolar disorder over a six-month period, reducing missed doses from 48% to 25% in the previous week.

Participants also experienced improvements in bipolar disorder symptoms, with significant reductions in scores on the Brief Psychiatric Rating Scale and Hamilton Depression Rating Scale, indicating that better adherence may lead to better overall mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month outcomes of customized adherence enhancement (CAE) therapy in bipolar disorder. Sajatovic, M., Levin, J., Tatsuoka, C., et al.[2021]

The study involving 30 homeless individuals with schizophrenia showed that a combination of customized adherence enhancement (CAE) and long-acting injectable antipsychotic (LAI) treatment led to a significant increase in medication adherence, with 76% adherence at 6 months and a reduction in missed oral medications from 46% to 10%.

Participants also experienced significant improvements in psychiatric symptoms and overall functioning, although akathisia was noted as a major side effect of the LAI treatment, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. Sajatovic, M., Levin, J., Ramirez, LF., et al.[2022]

Patients with severe mental illness who do not adhere to treatment experience significantly worse outcomes, including more hospitalizations and interpersonal conflicts, highlighting the importance of adherence to psychiatric medications.

The combination of Customized Adherence Enhancement (CAE) with long-acting injectable antipsychotics (LAI) has been shown to improve treatment adherence across diverse patient demographics and diagnoses, demonstrating its effectiveness in optimizing care for patients with severe mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Medication Adherence Support Plus Long-Acting Injectable Antipsychotic Medication: A Post-Hoc Analysis of 3 Pilot Studies. Canales, T., Rodman, S., Conklin, D., et al.[2023]

A pilot trial involving 30 individuals with bipolar disorder showed that combining a behavioral adherence enhancement approach with long-acting injectable aripiprazole significantly improved medication adherence, reducing missed doses from 50.1% to 16.9% over 24 weeks.

Participants also experienced significant improvements in bipolar symptoms and overall functioning, as measured by various psychiatric scales, indicating that this combined approach may enhance recovery outcomes for those with medication adherence challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder. Sajatovic, M., Levin, JB., Ramirez, LF., et al.[2022]

The Customized Adherence Enhancement (CAE) program significantly improved medication adherence in individuals with bipolar disorder compared to a standard educational program, with notable improvements in adherence scores at 6 months.

Participants in the CAE group also showed better functioning, as indicated by higher Global Assessment of Functioning scores, and utilized mental health services less than those in the educational program, suggesting a more effective approach to managing bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. Sajatovic, M., Tatsuoka, C., Cassidy, KA., et al.[2019]

Adherence therapy, which promotes shared decision-making between patients and healthcare professionals, has the potential to improve medication adherence in schizophrenia, which is crucial for managing symptoms and preventing relapse.

While results from trials on adherence therapy have been mixed, there is promising evidence that training mental health workers in medication management can lead to better clinical outcomes, suggesting that all mental health nurses should receive this training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing medication adherence in people with schizophrenia: an international programme of research. Gray, R., White, J., Schulz, M., et al.[2010]

Psychoeducational groups significantly improve medication compliance in schizophrenia patients, leading to lower readmission rates, with only 0.30% of participants in these groups being readmitted compared to 2.32% in the control group.

The study highlights that first-episode patients and those with a history of schizophrenia also benefit from this approach, showing readmission rates of 0.04% and 0.61% respectively in the psychoeducational group versus much higher rates in controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the efficacy of psychoeducative groups in schizophrenic patients]. Eguiluz, I., González Torres, MA., Muñoz, P., et al.[2007]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24434094/

Prospective trial of customized adherence enhancement plus ... CAE-L appears to be associated with improved adherence, symptoms, and functioning in homeless or recently homeless individuals with schizophrenia or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04622150

Effectiveness RCT of Customized Adherence ... ... data is entered into the common informatics platform by NIMH, called the National Database for Clinical Trials Related to Mental Illness (http://ndct.nimh ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844018380824

A customized adherence enhancement program combined ... CAE-L Study 2 was a 6-month prospective, uncontrolled trial of CAE-L in 30 recently homeless individuals with schizophrenia or schizoaffective disorder which ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9351150/

A randomized controlled trial of customized adherence ... Telemedicine interventions for medication adherence in mental illness: a systematic review. ... Six-month outcomes of customized adherence ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06061952/cae-for-poorly-adherent-individuals-with-schizophrenia

CAE for Poorly Adherent Individuals With Schizophrenia Condition. Psychosis. Tourette's Syndrome. Schizotypal Personality ... Treatment. Customized Adherence Enhancement for Schizophrenia (CAE-S).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4129952/

A prospective trial of customized adherence enhancement ... Safety measures. Biological and safety outcomes included body mass index (BMI), vital signs, and laboratory testing. Laboratory testing was conducted at ...

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-03695-8

An interventional pilot of customized adherence enhancement ... Safety data and LAI dosage. Among the 19 individuals who completed baseline evaluation and went on to received CAE-L, there was 1 serious ...