Customized Adherence Enhancement for Bipolar Disorder

(CAE-E Trial)

Not currently recruiting at 2 trial locations

Overseen By Martha Sajatovic, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must be taking: Mood stabilizers

Disqualifiers: Too psychotic, High suicide risk, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method called Customized Adherence Enhancement (CAE) to help people with bipolar disorder stick to their medication plans. Participants will either try the CAE approach or continue with an enhanced version of their usual treatment, known as Enhanced Treatment as Usual (eTAU). The trial targets individuals who have had bipolar disorder for at least two years and struggle with regular medication adherence. Participants must receive care at specific health systems and have their own cell phone for receiving text messages. The goal is to find a simple way to improve medication adherence and outcomes for those with bipolar disorder. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for bipolar disorder.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must have been on a mood-stabilizing medication for at least six months, it seems likely that you will continue your current treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Customized Adherence Enhancement (CAE) can help individuals with bipolar disorder adhere to their medication, improve symptoms, and enhance overall functioning. Previous studies have not identified any major safety issues with CAE, but further research is needed to confirm these findings.

While specific safety data for CAE is lacking, it is important to note that this method employs behavioral strategies to support medication adherence, rather than introducing new drugs. This likely reduces the risk of side effects compared to treatments involving new medications. Overall, CAE appears to be a promising approach to managing bipolar disorder, with no significant safety concerns reported thus far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Customized Adherence Enhancement (CAE) for bipolar disorder because it offers a personalized approach to improving treatment adherence, which is often a challenge with this condition. Unlike typical medication or therapy options that focus directly on symptom management, CAE is designed to understand and address individual barriers to following treatment plans. By tailoring strategies to each person's needs, CAE has the potential to significantly enhance the effectiveness of existing treatments by ensuring patients stick to their prescribed regimens. This method aims to empower patients in managing their condition more effectively, which could lead to better overall outcomes.

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

Research has shown that Customized Adherence Enhancement (CAE) therapy, which participants in this trial may receive, can help people with bipolar disorder take their medication more regularly. In a six-month study, CAE improved medication habits, reduced symptoms, and enhanced daily functioning. This method identifies and addresses personal challenges that hinder patients from following their medication plans. While these results are encouraging, further studies are needed to confirm them. The goal is to provide a practical solution for those who struggle to maintain their medication routine. Another group in this trial will receive Enhanced Treatment as Usual (eTAU) as a control intervention. ^{1 2 3 6 7}

Who Is on the Research Team?

Martha Sajatovic, MD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults with Bipolar Disorder who struggle to stick to their medication regimen. They must have been treated with mood stabilizers like lithium or antipsychotics for at least six months, own a cell phone, and be able to give consent. It's not for those under 18, unable to consent or participate in interviews due to severe psychiatric symptoms, previous Phase 1 participants, or individuals at high suicide risk.

Inclusion Criteria

I often miss taking my bipolar disorder medication.

I own a cell phone capable of receiving text messages.

I have been diagnosed with Bipolar Disorder Type I or II.

Exclusion Criteria

I am under 18 years old.

Unable or unwilling to give written, informed consent to study participation

You have a high risk of suicide and cannot be safely treated where you currently receive care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Customized Adherence Enhancement (CAE) or Enhanced Treatment as Usual (eTAU) for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Implementation Assessment

Identify barriers and facilitators to CAE implementation to inform scale-up

Concurrent with treatment phase

What Are the Treatments Tested in This Trial?

Interventions

• Customized Adherence Enhancement (CAE)
• Enhanced Treatment as Usual (eTAU)

Trial Overview The study compares two methods: Customized Adherence Enhancement (CAE), which uses technology and a curriculum-based approach; versus Enhanced Treatment as Usual (eTAU) in public mental health settings. The goal is to see if CAE can better help people with Bipolar Disorder follow their medication plans.

How Is the Trial Designed?

Group I: Customized Adherence Enhancement (CAE) Experimental Treatment 1 Intervention

This arm will receive the experimental intervention, Customized Adherence Enhancement (CAE).

Group II: Enhanced Treatment as Usual (eTAU) Active Control 1 Intervention

This arm will receive the control intervention, Enhanced Treatment as Usual (eTAU).

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

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]

In a three-month trial involving 43 individuals with bipolar disorder, a psychosocial intervention called customized adherence enhancement (CAE) significantly improved medication adherence from 34% to 10% of missed doses, indicating its effectiveness in promoting treatment compliance.

Participants also showed significant improvements in psychiatric symptoms, as measured by the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and Brief Psychiatric Rating Scale, suggesting that CAE not only helps with adherence but also enhances overall mental health functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized adherence enhancement for individuals with bipolar disorder receiving antipsychotic therapy. Sajatovic, M., Levin, J., Tatsuoka, C., et al.[2022]

In a study of 160 patients with bipolar disorder, 60.6% showed low adherence to their medication regimen, highlighting a significant challenge in managing the condition.

Factors such as being employed and having a history of more hospital days were linked to better medication adherence, suggesting that vocational support and psychoeducation could improve treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cross-sectional Analysis of Patterns and Predictors of Medication Adherence in Bipolar Disorder: Single Center Experience from South India. Selvakumar, N., Menon, V., Kattimani, S.[2022]

A review of 11 studies on interventions for improving medication adherence in bipolar disorder found that only five showed significant improvements in adherence, but most interventions led to better clinical outcomes.

The study suggests that incorporating patient preferences into adherence measures, particularly in disorder-specific psychosocial interventions, could enhance both adherence and clinical results, although more research is needed to confirm this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions to improve medication adherence in bipolar disorder. Crowe, M., Porter, R., Inder, M., et al.[2012]

A multicomponent technology-assisted system for enhancing medication adherence in bipolar disorder was found to be feasible and well-received by patients, with high usability scores reported over a 15-day trial involving five participants.

The system led to improvements in medication adherence, bipolar disorder knowledge, and symptoms, with a notable 40% increase in treatment knowledge scores, although challenges were noted in adapting the system for various pill container types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis. Sajatovic, M., Davis, MS., Cassidy, KA., et al.[2020]

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]

Almost half (49.5%) of the 1,052 outpatients with bipolar disorder surveyed reported being nonadherent to their medication, highlighting a significant challenge in managing this condition.

Factors positively influencing medication adherence included having a college degree and higher satisfaction with antipsychotic medication, while negative influences included female sex, alcohol use, and higher scores on measures of symptoms and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of medication adherence among patients with bipolar disorder: results of the bipolar evaluation of satisfaction and tolerability (BEST) study: a nationwide cross-sectional survey. Bates, JA., Whitehead, R., Bolge, SC., 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]

Poor medication adherence is a significant issue for individuals with bipolar disorder, leading to increased disability and financial costs, influenced by various personal and external factors.

Research from 2005-2015 highlights potential strategies to improve adherence, such as addressing knowledge gaps and using technology, but further efforts are needed to make these interventions accessible and practical for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Adherence in Patients with Bipolar Disorder: A Comprehensive Review. Levin, JB., Krivenko, A., Howland, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3342843/

Six-month outcomes of customized adherence ... CAE was associated with improvements in adherence, symptoms, and functional status. Controlled trials are needed to confirm these preliminary findings. Keywords ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35927740/

study protocol for a hybrid effectiveness-implementation project CAE is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04622150

Effectiveness RCT of Customized Adherence ... Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422000556

A customized adherence enhancement program for ... This report describes the methodology and design of the ImprovinG adhereNce In adolescenTs with bipolar disordEr (IGNITE) study.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/bdi.13489

A 6‐month, prospective, randomized controlled trial of ... Six-month outcomes of customized adherence enhancement (CAE) therapy in bipolar disorder. Research support, N.I.H., extramural. Bipolar Disord.

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06517-0

study protocol for a hybrid effectiveness-implementation project CAE is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention.

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

A customized adherence enhancement program combined ... This report describes the methodological details of an ongoing, first-ever refinement and preliminary testing of CAE-L in poorly adherent patients with CPD in ...