Customized Medication Adherence Enhancement for Adults With Bipolar Disorder (UH CAE)

University Hospitals (UH)

Status: Completed

Conditions: Bipolar Disorder

Treatments: Behavioral: Medication routines management module; Behavioral: Substance use module; Behavioral: Psychoeducation module; Behavioral: Improved communication/rapport with provider module

Study type: Interventional

Funder types: Other

Identifiers

NCT00830310

AZ-IRUSQUET0455

L1195

Details and patient eligibility

About

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.

Full 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. The modules are components of a single, customized intervention. Although some participants may receive a different combination or number of modules, the participants are neither analyzed separately as a subpopulation nor compared as subpopulations. Therefore participants are all part of a solitary study arm. The effectiveness of the entire customized intervention system is of interest.

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. These meetings with the interventionist will consist of whatever modules were assigned at baseline that are customized to that particular participant's treatment adherence vulnerabilities. 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Bipolar Disorder (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 20% or more of medication within either the past week or past month (those missing 20% or more within past week will be considered to be non-adherent over the past month).
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Customized Adherence Enhancement (CAE)

Experimental group

Description:

Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the Attitudes toward Mood Stabilizers Questionnaire (AMSQ) and reasons for non-adherence on the Rating of Medication Influences (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.

Treatment:

Behavioral: Improved communication/rapport with provider module

Behavioral: Medication routines management module

Behavioral: Psychoeducation module

Behavioral: Substance use module