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Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00763919
First received: September 29, 2008
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Bipolar Disorder
Behavioral: Psychoeducation module
Behavioral: Substance abuse module
Behavioral: Improved communication/rapport with provider module
Behavioral: Medication routines management module

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Customized Adherence Enhancement in Bipolar Disorder (CAE in BD)

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.

  • Change in Treatment Adherence as Measured by the Morisky Scale [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.


Secondary Outcome Measures:
  • Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 Attitude as Measured by the Rating of Medication Influences (ROMI) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.

  • Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.

  • Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.

  • Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.

  • Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.

  • Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.

  • Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.

  • Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.

  • Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.

  • Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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 Attitude as Measured by the Rating of Medication Influences (ROMI) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.

  • Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.


Enrollment: 43
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Customized Adherence Enhancement (CAE)

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

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.
Behavioral: Substance abuse module
The substance abuse module will address problematic substance abuse, particularly as it relates to medication adherence.
Behavioral: 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763919

Locations
United States, Ohio
Connections
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00763919     History of Changes
Other Study ID Numbers: R34 MH078967-02, R34MH078967
Study First Received: September 29, 2008
Results First Received: October 24, 2011
Last Updated: October 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Case Western Reserve University:
Patient Non-Adherence
Patient Non-Compliance
Patient Nonadherence
Patient Noncompliance
Patient Refusal of Treatment
Refusal of Treatment
Treatment Refusal

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014