Bipolar Disorder
Conditions
Brief summary
Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.
Interventions
BEHAVIORALCustomized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)
Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one "booster" in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the "booster" session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers \& Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience.
BEHAVIORALEnhanced Treatment as Usual (ETAU)
Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes).
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5) * Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month * If \< 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if \> 18 years, able and willing to provide written informed consent * Fluent in English
Exclusion criteria
* Unable to receive care in the outpatient setting due to illness severity * A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder * Documented or suspected IQ \< 70 * Prior enrollment in CAE or Phase 2 * Have recently (in the past month) started a new psychotherapy/behavioral intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks | 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 | 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 Counter at 24 Weeks | Baseline and 24 weeks | A special pill cap/box will record the time/date of bottle opening. 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMartha Sajatovic, MD
Case Western Reserve University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Customized Adherence Enhancement for AYA This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA).
Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one booster in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the booster session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers & Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience. | 17 |
| Enhanced Treatment as Usual (ETAU) This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).
Enhanced Treatment as Usual (ETAU): Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes). | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Enhanced Treatment as Usual (ETAU) | Total | Customized Adherence Enhancement for AYA |
|---|---|---|---|
| Age, Continuous | 19.1 years STANDARD_DEVIATION 1.8 | 19.1 years STANDARD_DEVIATION 2 | 19.2 years STANDARD_DEVIATION 2.3 |
| Age diagnosed with Bipolar Disorder | 16.3 years STANDARD_DEVIATION 3.6 | 16 years STANDARD_DEVIATION 4.1 | 15.7 years STANDARD_DEVIATION 4.8 |
| Attention-deficit/hyperactivity disorder Diagnosis No | 5 Participants | 14 Participants | 9 Participants |
| Attention-deficit/hyperactivity disorder Diagnosis Yes | 14 Participants | 22 Participants | 8 Participants |
| Current living situation Living Alone | 0 Participants | 4 Participants | 4 Participants |
| Current living situation Living with others | 7 Participants | 14 Participants | 7 Participants |
| Current living situation With parents/guardian/caregiver | 12 Participants | 18 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 32 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Family History of Bipolar Disorder Don't Know | 1 Participants | 1 Participants | 0 Participants |
| Family History of Bipolar Disorder No | 4 Participants | 12 Participants | 8 Participants |
| Family History of Bipolar Disorder Yes | 14 Participants | 23 Participants | 9 Participants |
| Hospitalization history No | 10 Participants | 16 Participants | 6 Participants |
| Hospitalization history Yes | 9 Participants | 20 Participants | 11 Participants |
| Household income 0-35K | 6 Participants | 12 Participants | 6 Participants |
| Household income 150k+ | 3 Participants | 4 Participants | 1 Participants |
| Household income 36-75k | 3 Participants | 7 Participants | 4 Participants |
| Household income 76-150k | 2 Participants | 5 Participants | 3 Participants |
| Household income Decline/Don't Know | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 28 Participants | 13 Participants |
| Sex/Gender, Customized Gender Female | 11 Participants | 24 Participants | 13 Participants |
| Sex/Gender, Customized Gender Male | 6 Participants | 8 Participants | 2 Participants |
| Sex/Gender, Customized Gender Other | 2 Participants | 4 Participants | 2 Participants |
| Years of education | 12.8 years STANDARD_DEVIATION 1.6 | 12.7 years STANDARD_DEVIATION 1.9 | 12.6 years STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 19 |
| other Total, other adverse events | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 3 / 17 | 0 / 19 |
Outcome results
Primary
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.
Time frame: Baseline and 24 weeks
Population: Only those with complete data for TRQ past month at baseline and 24 weeks were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Customized Adherence Enhancement for AYA | Change From Baseline in the Tablet Routine Questionaire (TRQ) Past Month Item at 24 Weeks | 21.5 percent of medications not taken | Standard Deviation 17 |
| Enhanced Treatment as Usual (ETAU) | Change From Baseline in the Tablet Routine Questionaire (TRQ) Past Month Item at 24 Weeks | 28.0 percent of medications not taken | Standard Deviation 35.8 |
Primary
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.
Time frame: Baseline and 24 weeks
Population: Only those with complete data for TRQ past week at baseline and 24 weeks were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Customized Adherence Enhancement for AYA | Change From Baseline in the Tablet Routine Questionaire (TRQ) Past Week Item at 24 Weeks | 27.9 percent of medications not taken | Standard Deviation 27.9 |
| Enhanced Treatment as Usual (ETAU) | Change From Baseline in the Tablet Routine Questionaire (TRQ) Past Week Item at 24 Weeks | 28.6 percent of medications not taken | Standard Deviation 36.1 |
Primary
Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks
A special pill cap/box will record the time/date of bottle opening. 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.
Time frame: Baseline and 24 weeks
Population: Only those with complete data from the pill counter at baseline and 24 weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Customized Adherence Enhancement for AYA | Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks | 85.7 percentage of doses taken | Standard Deviation 16.5 |
| Enhanced Treatment as Usual (ETAU) | Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks | 50.0 percentage of doses taken | Standard Deviation 36 |