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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: Completed NA study, sponsored by Case Western Reserve University.
NCT01542008 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 184 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
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 |
What the finished NCT01542008 record still lists
NCT01542008 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Customized Adherence Enhancement (CAE) is the first listed.
NCT01542008 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01542008's enrollment target sits among peer trials
184 581st of 2000 higher than 1,417 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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