Treatment Adherence Enhancement in Bipolar Disorder (CAE RCT)

December 13, 2018 updated by: Martha Sajatovic, MD, Case Western Reserve University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Customized Adherence Enhancement (CAE)
This arm will receive the CAE intervention.
Behavioral: 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.
Active Comparator: broad non-individualized education (EDU)
This arm will receive the EDU intervention.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks
Time Frame: Baseline and 24 weeks
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Baseline and 24 weeks
Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks
Time Frame: Baseline and 24 weeks
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Baseline and 24 weeks
Change from baseline in treatment adherence as measured by special pill cap counter at 24 weeks
Time Frame: Baseline and 24 weeks
A special pill cap will record the time/date of bottle opening. The cap will be used for the medication that the patient takes the most frequently (in the case of multiple BD medications taken at same frequency, the medication that was started most recently will be selected). A dose will be counted as "taken" if the bottle is opened within two hours of the prescribed time. A percent of doses taken (treatment adherence) will be calculated by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Brief Psychiatry Symptom Scale (BPRS) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Young Mania Rating Scale (YMRS) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Clinical Global Impression, Bipolar Version (CGI-BP) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Global Assessment of Functioning (GAF) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in General Self Efficacy Scale at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in the Drug and Alcohol portion of the Addiction Severity Index (ASI) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Treatment alliance (Trust in Providers scale) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Stigma for Mental Illness Scale at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from baseline in Drug Attitudes Inventory (DAI) at 24 weeks
Time Frame: baseline and 24 weeks
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Martha Sajatovic, M.D., University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH0933 21-01A1 (Other Grant/Funding Number: National Institite of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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