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Sponsors and Collaborators: |
University Hospitals of Cleveland Case Western Reserve University |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00830310 |
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 |
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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 |
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 |
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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;
Exclusion Criteria:
Contact: Kristin A Cassidy, MA | 216-844-2834 | kristin.cassidy@uhhospitals.org |
Contact: Edna Fuentes-Casiano, BSW | 216-844-2104 | effectiveness.research@uhhospitals.org |
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 |
Principal Investigator: | Martha Sajatovic, MD | Case Western Reserve University and University Hospitals Case Medical Center |
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 |
Patient Non-Adherence Patient Non-Compliance Patient Nonadherence Patient Noncompliance |
Patient Refusal of Treatment Refusal of Treatment Treatment Refusal |
Disulfiram Affective Disorders, Psychotic Mental Disorders |
Bipolar Disorder Mood Disorders Psychotic Disorders |
Affective Disorders, Psychotic Pathologic Processes Disease |
Mental Disorders Bipolar Disorder Mood Disorders |