Treatment Adherence Enhancement in Bipolar Disorder (CAE RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Case Western Reserve University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01542008
First received: February 24, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Treatment Noncompliance
Bipolar Disorder
Behavioral: Customized Adherence Enhancement (CAE)
Behavioral: broadly-directed, non-individualized education (EDU)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Adherence Enhancement in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.

  • Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.

  • Change from baseline in treatment adherence as measured by special pill cap counter at 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in Brief Psychiatry Symptom Scale (BPRS) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Young Mania Rating Scale (YMRS) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression, Bipolar Version (CGI-BP) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Global Assessment of Functioning (GAF) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in General Self Efficacy Scale at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Drug and Alcohol portion of the Addiction Severity Index (ASI) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Treatment alliance (Trust in Providers scale) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Stigma for Mental Illness Scale at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Drug Attitudes Inventory (DAI) at 24 weeks [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: April 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542008

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kristin Cassidy, M.A.    216-844-2834    Kristin.Cassidy@UHhospitals.org   
Contact: Kouri Akagi, B.A.    216-844-2835    Kouri.Akagi@UHhospitals.org   
Principal Investigator: Martha Sajatovic, M.D.         
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Martha Sajatovic, M.D. University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01542008     History of Changes
Other Study ID Numbers: 1R01MH0933​21-01A1, 1R01MH0933​21-01A1
Study First Received: February 24, 2012
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014