Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title: Customized Adherence Enhancement in Bipolar Disorder (CAE in BD)

Status Completed

Clinical Trial Summary

In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.

Clinical Trial Description

Bipolar disorder (BPD) is a chronic disorder characterized by manic and depressive episodes that disrupt healthy, functional lives. Despite recent advances in medication treatments, many BPD patients do not take their medications. Medication nonadherence is associated with multiple risks, such as relapse, rehospitalization, lengthier hospital stays, and, in some cases, increased risk of suicide. Some studies have shown that treatment adherence in BPD can be improved, particularly through psychological education, development of self-management strategies or behaviors, and ongoing relapse prevention.

This study will examine the effectiveness of medication adherence treatment modules specialized to deal with specific reasons for nonadherence. Participants, all of whom have a history of medication nonadherence, will undergo structured interviews and complete self-report questionnaires to determine individual reasons for nonadherence. Based on their individual profiles, participants will be assigned to one or more of the following intervention modules:

1. Psychoeducation: This module uses education about BPD and related treatment to address patient issues such as opposition to preventive efforts, denial of the need for or effectiveness of medication, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment related to BPD treatment.

2. Substance abuse: This module targets substance abuse problems that interfere with medication adherence.

3. Communication with providers: This module addresses fear of medication side effects by improving communication with health care providers.

4. Medication routines management: This module addresses difficulties establishing a medication routine and outside opposition to medications by developing strategies for consistent medication adherence routines.

Each module will involve four 60-minute sessions conducted in a 4- to 6-week period. The study therapist will conduct each of these sessions individually with the participant, combining or coadministering modules in a single session if participants are assigned to more than one module. Depending on which module or modules participants are assigned to, they may also be contacted by phone one to three times by the therapist to complete all module materials.

This study will be conducted in two phases. In the first, an initial group of participants will undergo the module treatments and then participants and therapists will be interviewed about the effectiveness and feasibility of the interventions. This feedback will be used to refine the modules. In the second phase, a second group of participants will undergo treatment in the refined modules and provide more feedback. All participants will continue with their regular treatment while undergoing module treatments.

Participation in this study will last 4 to 6 weeks, with follow-up interviews and assessments ending 6 months after completion of the intervention. In all, there will be five assessments, completed at an initial screening visit, just before treatment, just after treatment, and 3 and 6 months after the completion of treatment. The initial assessments will last 60 to 90 minutes and involve questionnaires and a structured interview. The other four assessments will last 45 to 60 minutes. Treatment adherence, attitudes toward medications, BPD symptoms, and overall functioning will be measured at each assessment. The number of pills used in each participant's prescription bottles will also be counted as a measure of medication adherence. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

• NCT number: NCT00763919
• Study type: Interventional
• Source: Case Western Reserve University
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Completion date: October 2010