Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder

NCT00763919 | Completed Results DMC

• 2 other identifiers: R34MH078967-02R34MH078967
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Patient Non-Adherence; Patient Non-Compliance; Patient Nonadherence; Patient Noncompliance; Patient Refusal of Treatment; Refusal of Treatment; Treatment Refusal

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (18)

• Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)

  baseline and 6 months

• Change in Attitude as Measured by the Rating of Medication Influences (ROMI)

  baseline and 6 months

• Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)

  baseline and 6 months

• Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)

  baseline and 6 months

• Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)

  baseline and 6 months

Study Arms (1)

Customized Adherence Enhancement (CAE)

EXPERIMENTAL

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

Interventions

Psychoeducation module BEHAVIORAL

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.

Customized Adherence Enhancement (CAE)

Substance abuse module BEHAVIORAL

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

Customized Adherence Enhancement (CAE)

Improved communication/rapport with provider module BEHAVIORAL

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.

Customized Adherence Enhancement (CAE)

Medication routines management module BEHAVIORAL

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.

Customized Adherence Enhancement (CAE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Connections

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Patient Compliance; Treatment Refusal

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Christopher Bialko
• Organization: University Hospitals Case Medical Center

Christopher.Bialko@UHhospitals.org

216-286-4362

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: October 1, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 20, 2014
• Results First Posted: December 21, 2011

Record last verified: 2014-10

Locations

US (1)