Trial Outcomes & Findings for Improving Adherence in Adolescents and Young Adults With Bipolar Disorder (NCT NCT04348604)
NCT ID: NCT04348604
Last Updated: 2024-10-10
Results Overview
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Baseline (Randomized)
STARTED
|
17
|
19
|
|
Baseline (Randomized)
COMPLETED
|
17
|
19
|
|
Baseline (Randomized)
NOT COMPLETED
|
0
|
0
|
|
Week 8
STARTED
|
17
|
19
|
|
Week 8
COMPLETED
|
15
|
15
|
|
Week 8
NOT COMPLETED
|
2
|
4
|
|
Week 12
STARTED
|
15
|
15
|
|
Week 12
COMPLETED
|
13
|
13
|
|
Week 12
NOT COMPLETED
|
2
|
2
|
|
Week 24
STARTED
|
13
|
13
|
|
Week 24
COMPLETED
|
11
|
12
|
|
Week 24
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Week 8
Withdrawal by Subject
|
1
|
1
|
|
Week 8
Lost to Follow-up
|
1
|
2
|
|
Week 8
Suspended
|
0
|
1
|
|
Week 12
Lost to Follow-up
|
1
|
2
|
|
Week 12
Withdrawal by Subject
|
1
|
0
|
|
Week 24
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Customized Adherence Enhancement for AYA
n=17 Participants
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.
|
Enhanced Treatment as Usual (ETAU)
n=19 Participants
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).
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.2 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
19.1 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
19.1 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age diagnosed with Bipolar Disorder
|
15.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
16.3 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
16 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Current living situation
Living Alone
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Current living situation
With parents/guardian/caregiver
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Current living situation
Living with others
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Household income
0-35K
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Household income
36-75k
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Household income
76-150k
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Household income
150k+
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Household income
Decline/Don't Know
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Years of education
|
12.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
12.8 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
12.7 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Hospitalization history
Yes
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Hospitalization history
No
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Family History of Bipolar Disorder
Yes
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Family History of Bipolar Disorder
No
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Family History of Bipolar Disorder
Don't Know
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Attention-deficit/hyperactivity disorder Diagnosis
Yes
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Attention-deficit/hyperactivity disorder Diagnosis
No
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: Only those with complete data for TRQ past month at baseline and 24 weeks were included in the analysis
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Outcome measures
| Measure |
Customized Adherence Enhancement for AYA
n=11 Participants
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.
|
Enhanced Treatment as Usual (ETAU)
n=11 Participants
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).
|
|---|---|---|
|
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
|
21.5 percent of medications not taken
Standard Deviation 17.0
|
28.0 percent of medications not taken
Standard Deviation 35.8
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: Only those with complete data for TRQ past week at baseline and 24 weeks were included in the analysis
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Outcome measures
| Measure |
Customized Adherence Enhancement for AYA
n=11 Participants
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.
|
Enhanced Treatment as Usual (ETAU)
n=11 Participants
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).
|
|---|---|---|
|
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
|
28.6 percent of medications not taken
Standard Deviation 36.1
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: Only those with complete data from the pill counter at baseline and 24 weeks were included in the analysis.
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.
Outcome measures
| Measure |
Customized Adherence Enhancement for AYA
n=4 Participants
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.
|
Enhanced Treatment as Usual (ETAU)
n=4 Participants
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).
|
|---|---|---|
|
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
|
50.0 percentage of doses taken
Standard Deviation 36.0
|
Adverse Events
Customized Adherence Enhancement for AYA
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual (ETAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Customized Adherence Enhancement for AYA
n=17 participants at risk
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.
|
Enhanced Treatment as Usual (ETAU)
n=19 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for Suicidal Ideation
|
11.8%
2/17 • Number of events 2 • Adverse events were collected during the study period of 6 months.
|
0.00%
0/19 • Adverse events were collected during the study period of 6 months.
|
|
General disorders
Hospitalization for Severe Electrolyte Imbalance
|
5.9%
1/17 • Number of events 1 • Adverse events were collected during the study period of 6 months.
|
0.00%
0/19 • Adverse events were collected during the study period of 6 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place