Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder

Not Applicable

Completed

Conditions: Bipolar Disorder

Interventions: Behavioral: Psychoeducation module
Behavioral: Substance abuse module
Behavioral: Improved communication/rapport with provider module
Behavioral: Medication routines management module

Registration Number: NCT00763919

Lead Sponsor: Case Western Reserve University

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

Inclusion Criteria

Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be nonadherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
BPD of at least 2 years' duration
Treatment with medication to stabilize mood for at least 6 months

Exclusion Criteria

Unable/unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current intent or plan
Inability to speak English
Individuals who have participated in Project 1, Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Customized Adherence Enhancement (CAE)	Psychoeducation module	Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules based on their individual profiles. Treatment Modules: Psychoeducation module Substance abuse module Improved communication/rapport with provider module Medication routines management module
Customized Adherence Enhancement (CAE)	Substance abuse module	Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules based on their individual profiles. Treatment Modules: Psychoeducation module Substance abuse module Improved communication/rapport with provider module Medication routines management module
Customized Adherence Enhancement (CAE)	Improved communication/rapport with provider module	Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules based on their individual profiles. Treatment Modules: Psychoeducation module Substance abuse module Improved communication/rapport with provider module Medication routines management module
Customized Adherence Enhancement (CAE)	Medication routines management module	Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules based on their individual profiles. Treatment Modules: Psychoeducation module Substance abuse module Improved communication/rapport with provider module Medication routines management module

Primary Outcome Measures

Name	Time	Method
Change in Treatment Adherence as Measured by the Morisky Scale	baseline and 6 months	The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire	baseline and 3 months	The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire	baseline and 3 months	The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.

Secondary Outcome Measures

Name	Time	Method
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)	baseline and 3 months	The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)	baseline and 3 months	The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)	baseline and 3 months	The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)	baseline and 3 months	The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)	baseline and 3 months	The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale	baseline and 3 months	The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)	baseline and 3 months	The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)	baseline and 3 months	The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)	baseline and 3 months	The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.