Treatment NoncomplianceCAE RCTNCT01542008
Treatment Adherence Enhancement in Bipolar Disorder
A study testing Customized Adherence Enhancement (CAE) and broadly-directed, non-individualized education (EDU) in people with Treatment Noncompliance and Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Noncompliance, Bipolar Disorder
- What is being tested?
- Customized Adherence Enhancement (CAE) and broadly-directed, non-individualized education (EDU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read more
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.
- Conditions
- Treatment Noncompliance, Bipolar Disorder
- Being tested
- Customized Adherence Enhancement (CAE), broadly-directed, non-individualized education (EDU)
- Medical subject headings
- Patient Compliance, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized Adherence Enhancement (CAE)Behavioural
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.
broadly-directed, non-individualized education (EDU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Customized Adherence Enhancement (CAE) | Experimental | This arm will receive the CAE intervention. Receives: Behavioral: Customized Adherence Enhancement (CAE) |
| broad non-individualized education (EDU) | Active comparator | This arm will receive the EDU intervention. Receives: Behavioral: broadly-directed, non-individualized education (EDU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Measured: Baseline and 24 weeks
Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Measured: Baseline and 24 weeks
Change from baseline in treatment adherence as measured by special pill cap counter at 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.
Measured: Baseline and 24 weeks
Secondary outcomes (10)
Change from baseline in Brief Psychiatry Symptom Scale (BPRS) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Young Mania Rating Scale (YMRS) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Clinical Global Impression, Bipolar Version (CGI-BP) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Global Assessment of Functioning (GAF) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in General Self Efficacy Scale at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in the Drug and Alcohol portion of the Addiction Severity Index (ASI) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Treatment alliance (Trust in Providers scale) at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Stigma for Mental Illness Scale at 24 weeks
Measured: baseline and 24 weeks
Change from baseline in Drug Attitudes Inventory (DAI) at 24 weeks
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment NoncomplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Martha Sajatovic, MD, Case Western Reserve University
- Investigators
- Martha Sajatovic, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542008
- Sponsor's protocol ID
- 1R01MH0933 21-01A1
- Other IDs
- 1R01MH0933 21-01A1
- Acronym
- CAE RCT
- Status last verified
- Dec 2018
- First submitted
- 24 Feb 2012
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29351117
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Adherence Enhancement in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01542008
- Acronym / sponsor ID
- CAE RCT / 1R01MH0933 21-01A1
- Conditions
- Treatment Noncompliance, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized Adherence Enhancement (CAE) | Experimental | Behavioral: Customized Adherence Enhancement (CAE)This arm will receive the CAE intervention. |
| broad non-individualized education (EDU) | Active comparator | Behavioral: broadly-directed, non-individualized education (EDU)This arm will receive the EDU intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Customized Adherence Enhancement (CAE) |
| 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. | Behavioural | broad non-individualized education (EDU) |
Primary outcome
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.
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.
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.
10 secondary outcomes
Change from baseline in Brief Psychiatry Symptom Scale (BPRS) at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in Young Mania Rating Scale (YMRS) at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in Clinical Global Impression, Bipolar Version (CGI-BP) at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in Global Assessment of Functioning (GAF) at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in General Self Efficacy Scale at 24 weeks
Time frame: 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
Change from baseline in Treatment alliance (Trust in Providers scale) at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in Stigma for Mental Illness Scale at 24 weeks
Time frame: baseline and 24 weeks
Change from baseline in Drug Attitudes Inventory (DAI) at 24 weeks
Time frame: baseline and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 29351117Aftab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Sajatovic, M.D. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized Adherence Enhancement (CAE) and broadly-directed, non-individualized education (EDU) in people with Treatment Noncompliance and Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks (time frame: Baseline and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.