Customized Adherence Enhancement for Bipolar Disorder (CAE-E Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Case Western Reserve University
No Placebo Group
Trial Summary
What is the purpose of this trial?Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Building upon positive efficacy trial results, the proposed project will test the effectiveness of technology-facilitated Customized Adherence Enhancement (CAE) vs. enhanced treatment as usual (eTAU) using a prospective randomized controlled design in public mental health care settings and preferentially enrolling poorly adherent/high-risk individuals with BD. Deliverables include a curriculum-driven adherence enhancement approach that can be implemented in public healthcare settings and which can improve outcomes for the most vulnerable groups of people with BD.
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on medication adherence, it is likely that you will continue your current treatment.
What safety data exists for Customized Adherence Enhancement for Bipolar Disorder?The provided research does not contain specific safety data for Customized Adherence Enhancement (CAE) or Enhanced Treatment as Usual (eTAU) for Bipolar Disorder. The studies focus on medication adherence and adverse effects related to antiepileptic drugs in epilepsy, not on CAE or eTAU for Bipolar Disorder.3891014
What data supports the idea that Customized Adherence Enhancement for Bipolar Disorder is an effective treatment?The available research shows that Customized Adherence Enhancement (CAE) is effective for people with bipolar disorder who struggle to take their medication regularly. In a study involving 43 individuals who were not taking their medication as prescribed, CAE was tested over three months. The results indicated that this treatment helped improve their medication-taking habits. This suggests that CAE can be a helpful approach for managing bipolar disorder by ensuring patients stick to their medication plans.124611
Is Customized Adherence Enhancement (CAE) a promising treatment for people with bipolar disorder?Yes, Customized Adherence Enhancement (CAE) is a promising treatment for people with bipolar disorder. It helps improve how well people stick to their medication plans by focusing on their individual needs and challenges. This approach has shown positive results in trials, making it a valuable option for those struggling with medication adherence.2571213
Eligibility Criteria
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.
I have been on mood-stabilizing medication for at least 6 months.
Exclusion Criteria
I am under 18 years old.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Customized Adherence Enhancement (CAE)Experimental Treatment1 Intervention
This arm will receive the experimental intervention, Customized Adherence Enhancement (CAE).
Group II: Enhanced Treatment as Usual (eTAU)Active Control1 Intervention
This arm will receive the control intervention, Enhanced Treatment as Usual (eTAU).
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Nord CenterLorain, OH
MetroHealth Medical CenterCleveland, OH
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Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
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. [2022]To identify and describe correlates of medication adherence in a large, national sample of outpatients with bipolar disorder.
Customized adherence enhancement for individuals with bipolar disorder receiving antipsychotic therapy. [2022]A three-month prospective trial of a psychosocial intervention--customized adherence enhancement (CAE)--was conducted with 43 medication-nonadherent individuals with bipolar disorder.
Effects of antiepileptic drug characteristics on medication adherence. [2012]To determine whether antiepileptic drug (AED) characteristics are associated with medication adherence.
Effectiveness of interventions to improve medication adherence in bipolar disorder. [2012]To identify interventions that improve medication adherence in bipolar disorder.
Six-month outcomes of customized adherence enhancement (CAE) therapy in bipolar disorder. [2021]There are few psychosocial interventions specifically focused on improved treatment adherence in people with bipolar disorder (BD). Customized adherence enhancement (CAE) is a needs-based, manualized approach intended to improve medication adherence in individuals with BD. This was a six-month prospective trial of a CAE among 43 medication non-adherent individuals with BD who were receiving treatment in a community mental health clinic (CMHC).
A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis. [2020]As poor medication adherence is common in bipolar disorder (BD), technology-assisted approaches may help to monitor and enhance adherence. This study evaluated preliminary feasibility, patient satisfaction and effects on adherence, BD knowledge, and BD symptoms associated with the use of a multicomponent technology-assisted adherence enhancement system.
Medication Adherence in Patients with Bipolar Disorder: A Comprehensive Review. [2022]Poor medication adherence is a pervasive problem that causes disability and suffering as well as extensive financial costs among individuals with bipolar disorder (BD). Barriers to adherence are numerous and cross multiple levels, including factors related to bipolar pathology and those unique to an individual's circumstances. External factors, including treatment setting, healthcare system, and broader health policies, can also affect medication adherence in people with BD. Fortunately, advances in research have suggested avenues for improving adherence. A comprehensive review of adherence-enhancement interventions for the years 2005-2015 is included. Specific bipolar adherence-enhancement approaches that target knowledge gaps, cognitive patterns, specific barriers, and motivation may be helpful, as may approaches that capitalize on technology or novel drug-delivery systems. However, much work remains to optimally facilitate long-term medication adherence in people with BD. For adherence-enhancement approaches to be widely adapted, they need to be easily accessible, affordable, and practical.
Association between addressing antiseizure drug side effects and patient-reported medication adherence in epilepsy. [2020]Adherence to treatment is a critical component of epilepsy management. This study examines whether addressing antiepileptic drug (AED) side effects at every visit is associated with increased patient-reported medication adherence.
Medication adherence and adverse effect profile of antiepileptic drugs in Nigerian patients with epilepsy. [2019]Medication adherence remains a major challenge among patients with epilepsy (PWE) with the adverse effect profile of antiepileptic drugs (AEDs) as one of its main drivers.
Liverpool Adverse Events Profile: Italian validation and predictive value for dropout from antiepileptic treatment in people with epilepsy. [2019]Adverse events (AEs) of antiepileptic drugs (AEDs) affect patient compliance and dropout. No questionnaire measuring AEs of AEDs is available for Italian-speaking people with epilepsy. Moreover, no questionnaire has been shown to predict patient dropout.
A Cross-sectional Analysis of Patterns and Predictors of Medication Adherence in Bipolar Disorder: Single Center Experience from South India. [2022]Our objective was to determine patterns and predictors of medication adherence in bipolar disorder.
A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. [2019]Nonadherence in bipolar disorder (BD) ranges from 20% to 60%. Customized adherence enhancement (CAE) is a brief, BD-specific approach that targets individual adherence barriers. This prospective, 6-month, randomized controlled trial conducted from October 2012 to July 2017 compared CAE versus a rigorous BD-specific educational program (EDU) on adherence, symptoms, and functional outcomes in poorly adherent individuals.
Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder. [2022]Objective: People with bipolar disorder (BD) often have difficulty with medication adherence. This pilot trial combined a behavioral customized adherence enhancement (CAE) approach with long-acting injectable (LAI) antipsychotic medication and assessed effects on adherence, BD symptoms, and functional status.
Adherence to levetiracetam for management of epilepsy: Assessment with electronic monitors. [2021]Anti-seizure medications are used to manage epilepsy and require long-term adherence to maintain therapeutic drug levels. We assessed adherence to levetiracetam and the use of a digital intervention to improve adherence in patients with epilepsy.