Clinical trial NCT01542008: Treatment Adherence Enhancement in Bipolar Disorder
Official title: Treatment Adherence Enhancement in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Noncompliance
Bipolar Disorder
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-03-01
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Change from baseline in treatment adherence as measured by special pill cap counter at 24 weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change from baseline in Brief Psychiatry Symptom Scale (BPRS) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Young Mania Rating Scale (YMRS) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Clinical Global Impression, Bipolar Version (CGI-BP) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Global Assessment of Functioning (GAF) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in General Self Efficacy Scale at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in the Drug and Alcohol portion of the Addiction Severity Index (ASI) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Treatment alliance (Trust in Providers scale) at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Stigma for Mental Illness Scale at 24 weeks
timeFrame: baseline and 24 weeks
measure: Change from baseline in Drug Attitudes Inventory (DAI) at 24 weeks
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martha Sajatovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.