Customized Medication Adherence Enhancement for Adults With Bipolar Disorder - Full Text View

Sponsors and Collaborators:	University Hospitals of Cleveland Case Western Reserve University
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00830310

Purpose

This study is a modular intervention that is intended to improve treatment adherence among individuals with bipolar disorder on atypical antipsychotic therapy who have been identified as having treatment adherence problems.

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Customized Adherence Enhancement (CAE) Among Individuals With Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Change in treatment adherence is based upon a composite of the Tablets Routine Questionnaire (TRQ) and of pill counts. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in symptoms of bipolar disorder as measured by the Young Mania Rating Scale/YMRS, the Hamilton Depression Rating Scale (HAM-D), and the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Global psychopathology as measured by the Clinical Global Impression scale (CGI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Overall treatment attitudes as measured by the Drug Attitude Inventory (DAI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Functional status as measure by the Global Assessment of Functioning scale (GAF) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	43
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Customized Adherence Enhancement (CAE): Experimental Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.	Behavioral: Psychoeducation module Individuals will be assigned to the psychoeducation module if they are identified as having opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes towards drugs in general, or lack of information about mood stabilizers operationalized as a score of "1" or higher on any of these AMSQ subscales. Additionally, those individuals who are non-adherent/sub-optimally adherent because of stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments will be assigned to participate in the psychoeducation module (ROMI stigma item or complementary/alternative treatment supplemental item). Behavioral: Substance use module Individuals will be assigned to the substance use intervention if they endorse the ROMI substance use item or if substance use is identified as problematic on the clinician assessment. Behavioral: Improved communication/rapport with provider module Individuals will be assigned to the provider communication/rapport module if they are identified as having fear of side effects operationalized as a score of "1" or higher on these AMSQ items. Additionally, those individuals who are non-adherent/suboptimally adherent because of concern regarding change in appearance "appearing medicated" or who experience side-effect-related distress as identified by the ROMI will be assigned to participate in the provider communication module. Behavioral: Medication routines management module Individuals will be assigned to the medication routines management if they are identified as having difficulties with medication routines operationalized as a score of "1" or higher on this AMSQ sub-scale, or if they are identified as experiencing outside opposition to medications by the ROMI.

Arms

Assigned Interventions

Customized Adherence Enhancement (CAE): Experimental

Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Behavioral: Psychoeducation module

Individuals will be assigned to the psychoeducation module if they are identified as having opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes towards drugs in general, or lack of information about mood stabilizers operationalized as a score of "1" or higher on any of these AMSQ subscales. Additionally, those individuals who are non-adherent/sub-optimally adherent because of stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments will be assigned to participate in the psychoeducation module (ROMI stigma item or complementary/alternative treatment supplemental item).

Behavioral: Substance use module

Individuals will be assigned to the substance use intervention if they endorse the ROMI substance use item or if substance use is identified as problematic on the clinician assessment.

Behavioral: Improved communication/rapport with provider module

Individuals will be assigned to the provider communication/rapport module if they are identified as having fear of side effects operationalized as a score of "1" or higher on these AMSQ items. Additionally, those individuals who are non-adherent/suboptimally adherent because of concern regarding change in appearance "appearing medicated" or who experience side-effect-related distress as identified by the ROMI will be assigned to participate in the provider communication module.

Behavioral: Medication routines management module

Individuals will be assigned to the medication routines management if they are identified as having difficulties with medication routines operationalized as a score of "1" or higher on this AMSQ sub-scale, or if they are identified as experiencing outside opposition to medications by the ROMI.

Detailed Description:

This study is a pilot, prospective project of the effects of customized adherence enhancement (CAE) when added to the medical management (usual care) of outpatients with bipolar disorder (BPD) who are patients at University Hospitals of Cleveland Case Medical Center, and who are known to be at risk for treatment non-adherence. In the proposed trial, CAE is supported by manuals delivered as a series of four modules whose use will be determined based upon an individual's identified treatment adherence vulnerabilities. All individuals will continue to receive treatment as usual with their regular provider. Those who are enrolled in the study intervention will participate in a series of 4 in-person meetings with the study interventionist over a 4-week time period and 1-2 telephone follow-ups. A total of 3 to 4 assessment meetings with the research assistant will occur over a three-month time period.

Primary objective The aim of this project is to test the use of a modular-based intervention in a pilot feasibility, acceptability and preliminary efficacy study of customized adherence enhancement (CAE) in a vulnerable population with BPD. We hypothesize that CAE will be: 1) feasible to administer within a academic medical center; 2) acceptable to participants with BPD; and 3) associated with improvements in treatment adherence.

Secondary objectives Individuals who receive CAE will have improvements in BPD symptoms, global psychopathology, overall treatment attitudes and in functional status.

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of BPD Type I or Type II determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (Sheehan 1998);
Demonstrated history of poor adherence as per either self-report or clinician report. In this study, self-reported treatment non-adherence will be identified with 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 non-adherent over the past month). Clinician-assessed non-adherence will be identified via a clinician version of the TRQ to identify non-adherence of 30% or more over the past 30 days;
BPD for at least two years duration;
Treatment with atypical antipsychotic medication to stabilize mood for at least six months;
The ability to participate in psychiatric interviews and to give written, informed consent for study participation; and
Age 18 or older.

Exclusion Criteria:

Unable/unwilling to participate in psychiatric interviews based on the clinical opinion of the investigator or the treating clinician. Individuals who are grossly psychotic may be excluded at this point if the treating clinician feels that the prospective participant is unable to participate in the interviews or study procedures;
Unable/unwilling to give written, informed consent to study participation;
High risk for suicide (e.g., active suicidal ideation and recent suicide attempt; active suicidal ideation and current intent or plan). In the interest of patient safety, individuals who are acutely suicidal will be excluded from study participation; or
Individuals who are non-English speaking will be excluded as study assessment tools are not available in other languages and would be impractical to develop in this small, exploratory study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830310

Contacts

Contact: Kristin A Cassidy, MA	216-844-2834	kristin.cassidy@uhhospitals.org
Contact: Edna Fuentes-Casiano, BSW	216-844-2104	effectiveness.research@uhhospitals.org

Locations

United States, Ohio
University Hospitals Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Edna Fuentes-Casiano, BSW 216-844-2104 effectiveness.research@uhhospitals.org
Contact: Melanie Athey, MA 216-844-2825 effectiveness.research@uhhospitals.org
Principal Investigator: Martha Sajatovic, MD
Sub-Investigator: Jennifer Levin, PhD

Sponsors and Collaborators

University Hospitals of Cleveland

Case Western Reserve University

Investigators

Principal Investigator:

Martha Sajatovic, MD

Case Western Reserve University and University Hospitals Case Medical Center

More Information

No publications provided

Responsible Party:	Case Western Reserve University and University Hospitals Case Medical Center ( Martha Sajatovic MD )
Study ID Numbers:	AZ-IRUSQUET0455, L1195
Study First Received:	January 23, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00830310 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Patient Non-Adherence
Patient Non-Compliance
Patient Nonadherence
Patient Noncompliance

Patient Refusal of Treatment
Refusal of Treatment
Treatment Refusal

Study placed in the following topic categories:

Disulfiram
Affective Disorders, Psychotic
Mental Disorders

Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Pathologic Processes
Disease

Mental Disorders
Bipolar Disorder
Mood Disorders

ClinicalTrials.gov processed this record on September 03, 2009