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Treatment Adherence Enhancement in Bipolar Disorder

NCT ID: NCT01542008

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-08-31

Brief Summary

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Bipolar disorder (BD) is a serious and chronic mental illness that is associated with substantial impairment in quality of life and functional outcomes, high rates of suicide, and high financial costs. In spite of a proliferation of treatments for BD, nearly half of individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication treatment adherence. Non-adherence with BD medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that adherence enhancement might work best if the intervention specifically addresses factors that are important and modifiable for a specific individual. In spite of the enormity of the problem, the literature on interventions to improve treatment adherence is surprisingly limited. There is an urgent need for interventions to enhance treatment adherence among BD patients that: 1) are at high risk for future treatment non-adherence; 2) may not have access to or interest in long-term, high-intensity, and specialized care; and 3) are flexible and patient-focused taking into account reasons for non-adherence for a specific individual.

The proposed study is a first-ever RCT focused specifically on BD treatment adherence enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial intervention improves adherence and mental health outcomes compared to broadly-directed, non-individualized education (EDU). The proposed project has the potential to greatly advance the care of BD patients who are at greatest risk for poor health outcomes, with findings expected to be generalizable across a variety of treatment settings.

Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared to broadly-directed, non-individualized BD education (EDU).

Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.

Detailed Description

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Conditions

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Treatment Noncompliance Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Customized Adherence Enhancement (CAE)

This arm will receive the CAE intervention.

Group Type EXPERIMENTAL

Customized Adherence Enhancement (CAE)

Intervention Type BEHAVIORAL

CAE consists of the application of a series of up to four psychosocial treatment modules based upon a baseline evaluation of adherence vulnerabilities/needs. The standardized modules (Psychoeducation, Modified Motivational Enhancement Therapy, Communication with Providers, Medication Routines), are assigned based upon pre-established criteria designed to fit the needs of the patient.

broad non-individualized education (EDU)

This arm will receive the EDU intervention.

Group Type ACTIVE_COMPARATOR

broadly-directed, non-individualized education (EDU)

Intervention Type BEHAVIORAL

EDU will consist of 4 core in-person sessions using the patient work-book from the NIMH funded study, Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), and following the general educational format of the Collaborative Care "control" intervention in the STEP study. EDU addresses BD treatment broadly, including diagnosis and management, and the sessions will review the materials and allow time for questions as needed.

Interventions

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Customized Adherence Enhancement (CAE)

CAE consists of the application of a series of up to four psychosocial treatment modules based upon a baseline evaluation of adherence vulnerabilities/needs. The standardized modules (Psychoeducation, Modified Motivational Enhancement Therapy, Communication with Providers, Medication Routines), are assigned based upon pre-established criteria designed to fit the needs of the patient.

Intervention Type BEHAVIORAL

broadly-directed, non-individualized education (EDU)

EDU will consist of 4 core in-person sessions using the patient work-book from the NIMH funded study, Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), and following the general educational format of the Collaborative Care "control" intervention in the STEP study. EDU addresses BD treatment broadly, including diagnosis and management, and the sessions will review the materials and allow time for questions as needed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Subjects must have type I or type II Bipolar Disorder (BD) as confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders Patient Version (SCID-P)
* Have had BD for at least two years duration
* Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
* Either 20% or more non-adherent with current BD medication treatment (i.e. lithium, anticonvulsant, or antipsychotic mood stabilizer)

Exclusion Criteria

* Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
* Unable or unwilling to give written, informed consent to study participation
* Individuals at high risk for suicide who can not be safely managed in their current treatment setting
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Martha Sajatovic, MD

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Sajatovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Aftab A, Levin J, Aebi M, Bhat C, Sajatovic M. Associations of Comorbid Anxiety With Medication Adherence and Psychiatric Symptomatology in a Population of Nonadherent Bipolar Disorder Subjects. J Nerv Ment Dis. 2018 Apr;206(4):258-262. doi: 10.1097/NMD.0000000000000788.

Reference Type DERIVED
PMID: 29351117 (View on PubMed)

Other Identifiers

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1R01MH0933 21-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R01MH0933 21-01A1

Identifier Type: -

Identifier Source: org_study_id