Treatment Adherence Enhancement in Bipolar Disorder

Summary

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.

Conditions

• Treatment Noncompliance
• Bipolar Disorder

Interventions

BEHAVIORAL

Customized Adherence Enhancement (CAE)

CAE consists of the application of a series of up to four psychosocial treatment modules based upon a baseline evaluation of adherence vulnerabilities/needs. The standardized modules (Psychoeducation, Modified Motivational Enhancement Therapy, Communication with Providers, Medication Routines), are assigned based upon pre-established criteria designed to fit the needs of the patient.

BEHAVIORAL

broadly-directed, non-individualized education (EDU)

EDU will consist of 4 core in-person sessions using the patient work-book from the NIMH funded study, Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), and following the general educational format of the Collaborative Care "control" intervention in the STEP study. EDU addresses BD treatment broadly, including diagnosis and management, and the sessions will review the materials and allow time for questions as needed.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Case Western Reserve University

  lead OTHER

Principal Investigators

• Martha Sajatovic, M.D. · University Hospitals Cleveland Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2017-07-31

Completion

2017-08-31

Countries

• United States

Study Locations