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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763919
• Other study ID #: R34MH078967-02
• Secondary ID: R34MH078967
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: October 9, 2014
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2014
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Psychoeducation module
The psychoeducation module will use psychological and medication education to address opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments.
• Substance abuse module
The substance abuse module will address problematic substance abuse, particularly as it relates to medication adherence.
• Improved communication/rapport with provider module
The provider communication and rapport module will improve health care provider communication to address fear of side effects, concern regarding change in appearance, or side effect-related distress.
• Medication routines management module
The medication routines management module will develop strategies and behaviors that help create medication adherence routines for those who have difficulties with medication routines or experience outside opposition to medications.

Locations

Country	Name	City	State
United States	Connections	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire	The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.	baseline and 6 months	No
Primary	Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire	The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.	baseline and 6 months	No
Primary	Change in Treatment Adherence as Measured by the Morisky Scale	The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.	baseline and 6 months	No
Primary	Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire	The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.	baseline and 3 months	No
Primary	Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire	The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.	baseline and 3 months	No
Secondary	Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)	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.	baseline and 6 months	No
Secondary	Change in Attitude as Measured by the Rating of Medication Influences (ROMI)	The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.	baseline and 6 months	No
Secondary	Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)	The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.	baseline and 6 months	No
Secondary	Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)	The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.	baseline and 6 months	No
Secondary	Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)	The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.	baseline and 6 months	No
Secondary	Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)	The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.	baseline and 6 months	No
Secondary	Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale	The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.	baseline and 6 months	No
Secondary	Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)	The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.	baseline and 6 months	No
Secondary	Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)	The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.	baseline and 6 months	No
Secondary	Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)	The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.	baseline and 3 months	No
Secondary	Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)	The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.	baseline and 3 months	No
Secondary	Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)	The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.	baseline and 3 months	No
Secondary	Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)	The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.	baseline and 3 months	No
Secondary	Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale	The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.	baseline and 3 months	No
Secondary	Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)	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.	baseline and 3 months	No
Secondary	Change in Attitude as Measured by the Rating of Medication Influences (ROMI)	The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.	baseline and 3 months	No
Secondary	Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)	The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.	baseline and 3 months	No
Secondary	Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)	The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.	baseline and 3 months	No