Treatment Adherence Enhancement in Bipolar Disorder (CAE RCT)

Case Western Reserve University

Status

Completed

Conditions

Treatment Noncompliance

Bipolar Disorder

Treatments

Behavioral: broadly-directed, non-individualized education (EDU)

Behavioral: Customized Adherence Enhancement (CAE)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01542008

1R01MH0933 21-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

Bipolar disorder (BD) is a serious and chronic mental illness that is associated with substantial impairment in quality of life and functional outcomes, high rates of suicide, and high financial costs. In spite of a proliferation of treatments for BD, nearly half of individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication treatment adherence. Non-adherence with BD medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that adherence enhancement might work best if the intervention specifically addresses factors that are important and modifiable for a specific individual. In spite of the enormity of the problem, the literature on interventions to improve treatment adherence is surprisingly limited. There is an urgent need for interventions to enhance treatment adherence among BD patients that: 1) are at high risk for future treatment non-adherence; 2) may not have access to or interest in long-term, high-intensity, and specialized care; and 3) are flexible and patient-focused taking into account reasons for non-adherence for a specific individual.

The proposed study is a first-ever RCT focused specifically on BD treatment adherence enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial intervention improves adherence and mental health outcomes compared to broadly-directed, non-individualized education (EDU). The proposed project has the potential to greatly advance the care of BD patients who are at greatest risk for poor health outcomes, with findings expected to be generalizable across a variety of treatment settings.

Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared to broadly-directed, non-individualized BD education (EDU).

Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.

Enrollment

184 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have type I or type II Bipolar Disorder (BD) as confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders Patient Version (SCID-P)
Have had BD for at least two years duration
Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
Either 20% or more non-adherent with current BD medication treatment (i.e. lithium, anticonvulsant, or antipsychotic mood stabilizer)

Exclusion criteria

Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
Unable or unwilling to give written, informed consent to study participation
Individuals at high risk for suicide who can not be safely managed in their current treatment setting