Bipolar DisorderNCT00763919
Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder
A study testing Psychoeducation module, Substance abuse module and Improved communication/rapport with provider module in people with Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Psychoeducation module, Substance abuse module and Improved communication/rapport with provider module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
- Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be nonadherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
- BPD of at least 2 years' duration
- Treatment with medication to stabilize mood for at least 6 months
Who cannot join
- Unable/unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
- High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current intent or plan
- Inability to speak English
- Individuals who have participated in Project 1, Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Customized Adherence Enhancement in Bipolar Disorder (CAE in BD)
In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.
Read the detailed description
Bipolar disorder (BPD) is a chronic disorder characterized by manic and depressive episodes that disrupt healthy, functional lives. Despite recent advances in medication treatments, many BPD patients do not take their medications. Medication nonadherence is associated with multiple risks, such as relapse, rehospitalization, lengthier hospital stays, and, in some cases, increased risk of suicide. Some studies have shown that treatment adherence in BPD can be improved, particularly through psychological education, development of self-management strategies or behaviors, and ongoing relapse prevention.
This study will examine the effectiveness of medication adherence treatment modules specialized to deal with specific reasons for nonadherence. Participants, all of whom have a history of medication nonadherence, will undergo structured interviews and complete self-report questionnaires to determine individual reasons for nonadherence. Based on their individual profiles, participants will be assigned to one or more of the following intervention modules:
- Psychoeducation: This module uses education about BPD and related treatment to address patient issues such as opposition to preventive efforts, denial of the need for or effectiveness of medication, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment related to BPD treatment.
- Substance abuse: This module targets substance abuse problems that interfere with medication adherence.
- Communication with providers: This module addresses fear of medication side effects by improving communication with health care providers.
- Medication routines management: This module addresses difficulties establishing a medication routine and outside opposition to medications by developing strategies for consistent medication adherence routines.
Each module will involve four 60-minute sessions conducted in a 4- to 6-week period. The study therapist will conduct each of these sessions individually with the participant, combining or coadministering modules in a single session if participants are assigned to more than one module. Depending on which module or modules participants are assigned to, they may also be contacted by phone one to three times by the therapist to complete all module materials.
This study will be conducted in two phases. In the first, an initial group of participants will undergo the module treatments and then participants and therapists will be interviewed about the effectiveness and feasibility of the interventions. This feedback will be used to refine the modules. In the second phase, a second group of participants will undergo treatment in the refined modules and provide more feedback. All participants will continue with their regular treatment while undergoing module treatments.
Participation in this study will last 4 to 6 weeks, with follow-up interviews and assessments ending 6 months after completion of the intervention. In all, there will be five assessments, completed at an initial screening visit, just before treatment, just after treatment, and 3 and 6 months after the completion of treatment. The initial assessments will last 60 to 90 minutes and involve questionnaires and a structured interview. The other four assessments will last 45 to 60 minutes. Treatment adherence, attitudes toward medications, BPD symptoms, and overall functioning will be measured at each assessment. The number of pills used in each participant's prescription bottles will also be counted as a measure of medication adherence.
- Conditions
- Bipolar Disorder
- Being tested
- Psychoeducation module, Substance abuse module, Improved communication/rapport with provider module, Medication routines management module
- Keywords
- Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Refusal of Treatment, Treatment Refusal
- Medical subject headings
- Bipolar Disorder, Patient Compliance, Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation moduleBehavioural
The psychoeducation module will use psychological and medication education to address opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments.
Substance abuse moduleBehavioural
The substance abuse module will address problematic substance abuse, particularly as it relates to medication adherence.
Improved communication/rapport with provider moduleBehavioural
The provider communication and rapport module will improve health care provider communication to address fear of side effects, concern regarding change in appearance, or side effect-related distress.
Medication routines management moduleBehavioural
The medication routines management module will develop strategies and behaviors that help create medication adherence routines for those who have difficulties with medication routines or experience outside opposition to medications.
| Study group | Role | What they receive |
|---|---|---|
| Customized Adherence Enhancement (CAE) | Experimental | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules based on their individual profiles.
Treatment Modules:
Psychoeducation module Substance abuse module Improved communication/rapport with provider module Medication routines management module Receives: Behavioral: Psychoeducation module; Behavioral: Substance abuse module; Behavioral: Improved communication/rapport with provider module; Behavioral: Medication routines management module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Measured: baseline and 6 months
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Measured: baseline and 6 months
Change in Treatment Adherence as Measured by the Morisky Scale
The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.
Measured: baseline and 6 months
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Measured: baseline and 3 months
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Measured: baseline and 3 months
Secondary outcomes (18)
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)
The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.
Measured: baseline and 6 months
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)
The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.
Measured: baseline and 6 months
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)
The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.
Measured: baseline and 6 months
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: baseline and 6 months
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Measured: baseline and 6 months
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)
The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.
Measured: baseline and 6 months
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Measured: baseline and 6 months
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Measured: baseline and 6 months
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.
Measured: baseline and 6 months
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)
The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.
Measured: baseline and 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: baseline and 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Measured: baseline and 3 months
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)
The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.
Measured: baseline and 3 months
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Measured: baseline and 3 months
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)
The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.
Measured: baseline and 3 months
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)
The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.
Measured: baseline and 3 months
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Measured: baseline and 3 months
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763919
- Sponsor's protocol ID
- R34MH078967-02
- Other IDs
- R34MH078967
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2008
- Last updated
- 20 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Adherence Enhancement in Bipolar Disorder (CAE in BD)
- ClinicalTrials.gov ID
- NCT00763919
- Acronym / sponsor ID
- R34MH078967-02
- Conditions
- Bipolar Disorder
- Keywords
- Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Refusal of Treatment, Treatment Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Posted 21 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.
Detailed description
Bipolar disorder (BPD) is a chronic disorder characterized by manic and depressive episodes that disrupt healthy, functional lives. Despite recent advances in medication treatments, many BPD patients do not take their medications. Medication nonadherence is associated with multiple risks, such as relapse, rehospitalization, lengthier hospital stays, and, in some cases, increased risk of suicide. Some studies have shown that treatment adherence in BPD can be improved, particularly through psychological education, development of self-management strategies or behaviors, and ongoing relapse prevention.
This study will examine the effectiveness of medication adherence treatment modules specialized to deal with specific reasons for nonadherence. Participants, all of whom have a history of medication nonadherence, will undergo structured interviews and complete self-report questionnaires to determine individual reasons for nonadherence. Based on their individual profiles, participants will be assigned to one or more of the following intervention modules:
- Psychoeducation: This module uses education about BPD and related treatment to address patient issues such as opposition to preventive efforts, denial of the need for or effectiveness of medication, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment related to BPD treatment.
- Substance abuse: This module targets substance abuse problems that interfere with medication adherence.
- Communication with providers: This module addresses fear of medication side effects by improving communication with health care providers.
- Medication routines management: This module addresses difficulties establishing a medication routine and outside opposition to medications by developing strategies for consistent medication adherence routines.
Each module will involve four 60-minute sessions conducted in a 4- to 6-week period. The study therapist will conduct each of these sessions individually with the participant, combining or coadministering modules in a single session if participants are assigned to more than one module. Depending on which module or modules participants are assigned to, they may also be contacted by phone one to three times by the therapist to complete all module materials.
This study will be conducted in two phases. In the first, an initial group of participants will undergo the module treatments and then participants and therapists will be interviewed about the effectiveness and feasibility of the interventions. This feedback will be used to refine the modules. In the second phase, a second group of participants will undergo treatment in the refined modules and provide more feedback. All participants will continue with their regular treatment while undergoing module treatments.
Participation in this study will last 4 to 6 weeks, with follow-up interviews and assessments ending 6 months after completion of the intervention. In all, there will be five assessments, completed at an initial screening visit, just before treatment, just after treatment, and 3 and 6 months after the completion of treatment. The initial assessments will last 60 to 90 minutes and involve questionnaires and a structured interview. The other four assessments will last 45 to 60 minutes. Treatment adherence, attitudes toward medications, BPD symptoms, and overall functioning will be measured at each assessment. The number of pills used in each participant's prescription bottles will also be counted as a measure of medication adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized Adherence Enhancement (CAE) | Experimental | Behavioral: Psychoeducation module, Behavioral: Substance abuse module, Behavioral: Improved communication/rapport with provider module, Behavioral: Medication routines management moduleParticipants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules based on their individual profiles. Treatment Modules: Psychoeducation module Substance abuse module Improved communication/rapport with provider module Medication routines management module |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
- Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be nonadherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
- BPD of at least 2 years' duration
- Treatment with medication to stabilize mood for at least 6 months
Key exclusion criteria (4 listed)
- Unable/unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
- High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current intent or plan
- Inability to speak English
- Individuals who have participated in Project 1, Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
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 |
|---|---|---|
| Psychoeducation moduleThe psychoeducation module will use psychological and medication education to address opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments. | Behavioural | Customized Adherence Enhancement (CAE) |
| Substance abuse moduleThe substance abuse module will address problematic substance abuse, particularly as it relates to medication adherence. | Behavioural | Customized Adherence Enhancement (CAE) |
| Improved communication/rapport with provider moduleThe provider communication and rapport module will improve health care provider communication to address fear of side effects, concern regarding change in appearance, or side effect-related distress. | Behavioural | Customized Adherence Enhancement (CAE) |
| Medication routines management moduleThe medication routines management module will develop strategies and behaviors that help create medication adherence routines for those who have difficulties with medication routines or experience outside opposition to medications. | Behavioural | Customized Adherence Enhancement (CAE) |
Primary outcome
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
Time frame: baseline and 6 months
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
Time frame: baseline and 6 months
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change in Treatment Adherence as Measured by the Morisky Scale
Time frame: baseline and 6 months
The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
Time frame: baseline and 3 months
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
Time frame: baseline and 3 months
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
18 secondary outcomes
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)
Time frame: baseline and 6 months
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)
Time frame: baseline and 6 months
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)
Time frame: baseline and 6 months
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
Time frame: baseline and 6 months
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
Time frame: baseline and 6 months
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)
Time frame: baseline and 6 months
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale
Time frame: baseline and 6 months
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)
Time frame: baseline and 6 months
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)
Time frame: baseline and 6 months
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)
Time frame: baseline and 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
Time frame: baseline and 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
Time frame: baseline and 3 months
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)
Time frame: baseline and 3 months
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale
Time frame: baseline and 3 months
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)
Time frame: baseline and 3 months
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)
Time frame: baseline and 3 months
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)
Time frame: baseline and 3 months
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)
Time frame: baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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, MD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation module, Substance abuse module and Improved communication/rapport with provider module in people with 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 4 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 20 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire (time frame: baseline and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2014.