|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Bipolar Disorder |
| Interventions: |
Behavioral: Psychoeducation module Behavioral: Substance abuse module Behavioral: Improved communication/rapport with provider module Behavioral: Medication routines management module |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| Customized Adherence Enhancement (CAE) | |
|---|---|
| STARTED | 43 |
| COMPLETED | 30 |
| NOT COMPLETED | 13 |
Baseline Characteristics
| Description | |
|---|---|
| Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| Customized Adherence Enhancement (CAE) | |
|---|---|
|
Number of Participants
[units: participants] |
43 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
38.4 ± 11.2 |
|
Gender
[units: participants] |
|
| Female | 30 |
| Male | 13 |
|
Region of Enrollment
[units: participants] |
|
| United States | 43 |
Outcome Measures
| 1. Primary: | Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire [ Time Frame: 6 months ] |
| 2. Primary: | Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire [ Time Frame: 6 months ] |
| 3. Primary: | Change in Treatment Adherence as Measured by the Morisky Scale [ Time Frame: 6 months ] |
| 4. Primary: | Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire [ Time Frame: 3 months ] |
| 5. Primary: | Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire [ Time Frame: 3 months ] |
| 6. Secondary: | Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ) [ Time Frame: 6 months ] |
| 7. Secondary: | Change in Attitude as Measured by the Rating of Medication Influences (ROMI) [ Time Frame: 6 months ] |
| 8. Secondary: | Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 months ] |
| 9. Secondary: | Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) [ Time Frame: 6 months ] |
| 10. Secondary: | Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 6 months ] |
| 11. Secondary: | Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: 6 months ] |
| 12. Secondary: | Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale [ Time Frame: 6 months ] |
| 13. Secondary: | Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: 6 months ] |
| 14. Secondary: | Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: 6 months ] |
| 15. Secondary: | Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 3 months ] |
| 16. Secondary: | Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) [ Time Frame: 3 months ] |
| 17. Secondary: | Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 3 months ] |
| 18. Secondary: | Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) [ Time Frame: 3 months ] |
| 19. Secondary: | Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale [ Time Frame: 3 months ] |
| 20. Secondary: | Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ) [ Time Frame: 3 months ] |
| 21. Secondary: | Change in Attitude as Measured by the Rating of Medication Influences (ROMI) [ Time Frame: 3 months ] |
| 22. Secondary: | Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: 3 months ] |
| 23. Secondary: | Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: 3 months ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Martha Sajatovic, National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00763919 History of Changes |
| Other Study ID Numbers: | R34 MH078967-02, R34MH078967-02, R34 MH078967, DAHBR 96-BHA |
| Study First Received: | September 29, 2008 |
| Results First Received: | October 24, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Federal Government |
