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NCT01542008 · ClinicalTrials.gov registry record · NA
Treatment Adherence Enhancement in Bipolar Disorder
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 184
- Enrollment target
NCT01542008 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 184 participants.
The verdict
NCT01542008, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 184 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Customized Adherence Enhancement (CAE)
- BEHAVIORAL broadly-directed, non-individualized education (EDU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2012-04 |
| Est. Completion | 2017-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01542008
The ClinicalTrials.gov registry entry for NCT01542008 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Customized Adherence Enhancement (CAE) is the first listed.
NCT01542008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01542008 about?
NCT01542008 is a clinical study titled "Treatment Adherence Enhancement in Bipolar Disorder". 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 benefi...
What is the current status of trial NCT01542008?
This trial is currently completed. It is a NA study. The enrollment target is 184 participants. The study started on 2012-04. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01542008?
The interventions under investigation include: Customized Adherence Enhancement (CAE) (BEHAVIORAL), broadly-directed, non-individualized education (EDU) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01542008?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
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