Bipolar Disorder, Medication Adherence, Medication Non Adherence
Conditions
Keywords
Antipsychotic Drugs, Antipsychotics, Injectables, Long Acting Injectable Antipsychotic, Bipolar Disorder, Medication Adherence, Medication Non-Adherence
Brief summary
This is a prospective study using customized adherence enhancement (CAE) and long-acting injectable (LAI) antipsychotic in 30 individuals with bipolar disorder (BD) at risk for treatment non-adherence. The CAE approach is expected to improve treatment adherence, as well as improve BD symptoms, functioning and treatment attitudes among subjects with bipolar disorder.
Detailed description
Oral Abilify (aripiprazole) is effective in the treatment of patients with BD when prescribed as an acute anti-manic agent and for the maintenance treatment of bipolar disorder. Abilify Maintena is an intramuscular (IM) depot formulation of oral aripiprazole (Abilify). Abilify Maintena appears to be as effective as standard oral Abilify and may maximize patient adherence. Recent clinical trials suggest that Abilify Maintena is effective for the treatment of patients with BD. Customized Adherence Enhancement (CAE) is a brief behavioral intervention that improves adherence approximately 30% more than an educational control in adults with BD. The CAE program is a brief, practical intervention consisting of a series of up to four psychosocial treatment modules based upon an adult's unique adherence barriers: 1) Psychoeducation on BD Medications; 2) Communication with Providers; 3) Strategies to Enhance Medication Routines; and 4) Targeting Substance Use Problems with Modified Motivational Enhancement Therapy. Multiple studies conducted by these investigators has shown that CAE is effective in in treating poorly adherent BD adults. In addition, studies by these investigators have shown that combining LAI + CAE dramatically improves adherence, symptoms and functional outcomes in people with schizophrenia and schizoaffective disorder. In summary, LAI can maximize medication adherence, while CAE addresses individual barriers to sustained adherence and behavioral change. Combining LAI + CAE improves adherence, symptoms and functioning in high-risk people with primary psychotic disorders. The proposed project will test the efficacy of combining Abilify Maintena with CAE to help improve outcomes in poorly adherent patients with BD. Pilot data suggest that adherence with concomitantly prescribed psychotropic drugs improves with LAI + CAE. The findings have particular relevance to BD because many BD patients are on concomitant oral psychotropic drugs in addition to antipsychotic. Thus, it is expected that combining CAE with LAI will lead to a halo effect in that these BD patients will engage in their own care more broadly.
Interventions
DRUGAbilify Maintena
Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.
BEHAVIORALCustomized Adherence Enhancement (CAE)
CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers).
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Martha Sajatovic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals age 18 and older with BD Type 1 or 2 as confirmed by the Mini International Psychiatric Inventory (MINI). 2. Known to have medication treatment adherence problems as identified by the Treatment Routines Questionnaire (TRQ, 20% or more missed medications in past week or past month) 3. Screening the Brief Psychiatric Rating Scale (BPRS) score of ≥ 36 4. Ability to be rated on psychiatric rating scales. 5. Willingness to take long-acting injectable antipsychotic medication (LAI) 6. Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation 7. Able to provide written, informed consent to study participation.
Exclusion criteria
1. Individuals on LAI immediately prior to study enrollment. 2. Individuals with known intolerance or resistance to either oral aripiprazole or LAI formulation of aripiprazole 3. Prior or current treatment with clozapine 4. Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial 5. Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist 6. Immediate risk of harm to self or others 7. Female who is currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tablets Routine Questionnaire (TRQ, Past Week) | Screen to Week 24 | Treatment non-adherence is measured as a percentage of medications not taken within the past week at time of assessment. The minimum score is 0% and the maximum score is 100%. A higher score implies poorer treatment adherence. |
| Change in Tablets Routine Questionnaire (TRQ, Past Month) | Screen to Week 24 | Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. |
| LAI Injection Adherence | Baseline to Week 24 | LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Global Impressions (CGI) Score | Screen to Week 24 | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. |
| Change in Drug Attitude Inventory (DAI) Score | Screen to Week 24 | DAI-10 scoring ranges from -10 to +10 with a total score \>0 indicating a positive attitude toward psychiatric medications and a total score of \<0 indicating a negative attitude toward psychiatric medications |
| Change in Attitude Towards Medication Questionnaire (AMSQ) Score | Screen to Week 24 | A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizers. The AMSQ is used to measure attitudes towards medications. The scale contains 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Responses which suggest positive attitudes towards medications are scored 0, while responses which suggest negative attitudes towards medications are scored 1. The items scores are added for a total score which is reported, with the minimum total score of 0 and maximum total score of 19. Higher scores on each subscale represent more negative attitudes toward mood stabilizers. |
| Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score | Baseline to Week 24 | The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning. |
| Change in the Brief Psychiatric Rating Scale (BPRS) Score | Baseline to Week 24 | The BPRS measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition. |
| Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score | Screen to Week 24 | The OBQ assess knowledge of BD management. Total score rangers from 0-80, with a higher score indicative of better knowledge of bipolar mood management. |
| Change in The Self-Report Habit Index (SRHI) Score | Screen to Week 24 | The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits. |
| Change in Communication Styles Scale Score | Screen to Week 24 | The Communication Styles Scale is a measure of the impact of physician communication style on medication beliefs and adherence behavior. Total scores range from 0-27 where the higher score indicates a more initial collaborative communication style. |
| Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score | Screen to Week 24 | The SOCRATES measures motivation to reduce the use of substances. The minimum score is 10 and the maximum score is 50. A higher score indicates a higher desire to reduce drinking. |
| Change in Global Assessment of Functioning (GAF) Score | Baseline to Week 24 | The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning. |
| Change in Young Mania Rating Scale (YMRS) Score | Screen to Week 24 | The YMRS measures symptoms of mania. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. |
| Change in Montgomery Asberg Rating Scale (MADRS) Score | Screen to Week 24 | The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. |
Countries
United States
Participant flow
Recruitment details
. Individuals were recruited from an academic medical center and via outreach to community settings including community mental health clinics (CMHCs). Enrolled participants had self-reported adherence problems as identified by the TRQ (≥20% missed BD medications in past week or past month), a screening Brief Psychiatric Rating Scale15 score ≥36, willingness to take LAI, and were in treatment at a CMHC or other clinical setting. Participants were adults ≥ age 18 with Type 1 or Type 2 BD.
Participants by arm
| Arm | Count |
|---|---|
| CAE-L Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention
Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.
Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Visit 1 Assessment (Baseline) | Lost to Follow-up | 3 |
| Visit 2 Assessment | Lost to Follow-up | 1 |
| Visit 3 Assessment | Withdrawal by Subject | 1 |
| Visit 4 Assessment | Lost to Follow-up | 2 |
| Visit 5 Assessment | Lost to Follow-up | 1 |
| Visit 6 Assessment | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CAE-L |
|---|---|
| Age at Bipolar onset | 27.63 years STANDARD_DEVIATION 11.8 |
| Age, Continuous | 49.47 years STANDARD_DEVIATION 9.28 |
| Duration of bipolar illness | 21.56 years STANDARD_DEVIATION 11.74 |
| Marital Status Married | 1 Participants |
| Marital Status Separated/Divorced/Widowed | 12 Participants |
| Marital Status Single, never married | 17 Participants |
| Mean lifetime psychiatric hospitalizations | 3.07 hospitalizations STANDARD_DEVIATION 3.43 |
| Mean lifetime substance abuse hospitalizations | 1.06 hospitalizations STANDARD_DEVIATION 2 |
| Mean Years of Education Attained | 13.63 years STANDARD_DEVIATION 2.85 |
| Number of Participants Who Live Alone | 16 Participants |
| Number of Participants With Current Substance Use Problems | 6 Participants |
| Number of Participants With Family history of Mental Illness | 28 Participants |
| Number of Participants With Family history of Substance Abuse | 23 Participants |
| Number of Participants With History of Physical Abuse | 16 Participants |
| Number of Participants With History of Sexual Abuse | 10 Participants |
| Occupation Status Full time employment/homemaker | 0 Participants |
| Occupation Status Other | 1 Participants |
| Occupation Status Part time employment/ homemaker or student | 4 Participants |
| Occupation Status Unemployed or on disability | 25 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Non Hispanic | 29 Participants |
| Race/Ethnicity, Customized Other or Multiracial | 4 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 23 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change in Tablets Routine Questionnaire (TRQ, Past Month)
Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Tablets Routine Questionnaire (TRQ, Past Month) | Screen | 40.6 percentage of missed BD medications | Standard Deviation 23.7 |
| CAE-L | Change in Tablets Routine Questionnaire (TRQ, Past Month) | Baseline | 29.4 percentage of missed BD medications | Standard Deviation 21.6 |
| CAE-L | Change in Tablets Routine Questionnaire (TRQ, Past Month) | Week 24 | 19.2 percentage of missed BD medications | Standard Deviation 24.5 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: 0.0599Wilcoxon (Mann-Whitney)
Comparison: We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: 0.63Wilcoxon (Mann-Whitney)
Primary
Change in Tablets Routine Questionnaire (TRQ, Past Week)
Treatment non-adherence is measured as a percentage of medications not taken within the past week at time of assessment. The minimum score is 0% and the maximum score is 100%. A higher score implies poorer treatment adherence.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Tablets Routine Questionnaire (TRQ, Past Week) | Screen | 50.1 percentage of missed BD medications | Standard Deviation 24.8 |
| CAE-L | Change in Tablets Routine Questionnaire (TRQ, Past Week) | Baseline | 37.5 percentage of missed BD medications | Standard Deviation 30 |
| CAE-L | Change in Tablets Routine Questionnaire (TRQ, Past Week) | Week 24 | 16.9 percentage of missed BD medications | Standard Deviation 26.97 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: 0.12Wilcoxon (Mann-Whitney)
Primary
LAI Injection Adherence
LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time).
Time frame: Baseline to Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAE-L | LAI Injection Adherence | 100 percentage of adherence | Standard Deviation 0 |
Secondary
Change in Attitude Towards Medication Questionnaire (AMSQ) Score
A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizers. The AMSQ is used to measure attitudes towards medications. The scale contains 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Responses which suggest positive attitudes towards medications are scored 0, while responses which suggest negative attitudes towards medications are scored 1. The items scores are added for a total score which is reported, with the minimum total score of 0 and maximum total score of 19. Higher scores on each subscale represent more negative attitudes toward mood stabilizers.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Attitude Towards Medication Questionnaire (AMSQ) Score | Screen | 7.9 score on a scale | Standard Deviation 3.3 |
| CAE-L | Change in Attitude Towards Medication Questionnaire (AMSQ) Score | Week 24 | 4.0 score on a scale | Standard Deviation 3.4 |
Comparison: We compared for the primary and secondary outcomes across two time-points: difference between screen and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Clinical Global Impressions (CGI) Score
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Clinical Global Impressions (CGI) Score | Screen | 4.6 score on a scale | Standard Deviation 0.5 |
| CAE-L | Change in Clinical Global Impressions (CGI) Score | Baseline | 4.1 score on a scale | Standard Deviation 0.6 |
| CAE-L | Change in Clinical Global Impressions (CGI) Score | Week 24 | 2.8 score on a scale | Standard Deviation 0.8 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Communication Styles Scale Score
The Communication Styles Scale is a measure of the impact of physician communication style on medication beliefs and adherence behavior. Total scores range from 0-27 where the higher score indicates a more initial collaborative communication style.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Communication Styles Scale Score | Screen | 22.4 score on a scale | Standard Deviation 4.2 |
| CAE-L | Change in Communication Styles Scale Score | Week 24 | 22.1 score on a scale | Standard Deviation 6.3 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: 0.73Wilcoxon (Mann-Whitney)
Secondary
Change in Drug Attitude Inventory (DAI) Score
DAI-10 scoring ranges from -10 to +10 with a total score \>0 indicating a positive attitude toward psychiatric medications and a total score of \<0 indicating a negative attitude toward psychiatric medications
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Drug Attitude Inventory (DAI) Score | Screen | 7.2 score on a scale | Standard Deviation 1.9 |
| CAE-L | Change in Drug Attitude Inventory (DAI) Score | Week 24 | 8.1 score on a scale | Standard Deviation 1.4 |
Comparison: We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.p-value: 0.0566Wilcoxon (Mann-Whitney)
Secondary
Change in Global Assessment of Functioning (GAF) Score
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Time frame: Baseline to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Global Assessment of Functioning (GAF) Score | Baseline | 53.5 score on a scale | Standard Deviation 8.1 |
| CAE-L | Change in Global Assessment of Functioning (GAF) Score | Week 24 | 70.7 score on a scale | Standard Deviation 7.9 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Montgomery Asberg Rating Scale (MADRS) Score
The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Montgomery Asberg Rating Scale (MADRS) Score | Screen | 24.5 score on a scale | Standard Deviation 5.7 |
| CAE-L | Change in Montgomery Asberg Rating Scale (MADRS) Score | Baseline | 18.1 score on a scale | Standard Deviation 9.4 |
| CAE-L | Change in Montgomery Asberg Rating Scale (MADRS) Score | Week 24 | 7.95 score on a scale | Standard Deviation 8.2 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.p-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score
The OBQ assess knowledge of BD management. Total score rangers from 0-80, with a higher score indicative of better knowledge of bipolar mood management.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score | Screen | 52.9 score on a scale | Standard Deviation 16.1 |
| CAE-L | Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score | Week 24 | 70.7 score on a scale | Standard Deviation 8.4 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score
The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning.
Time frame: Baseline to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score | Baseline | 51.9 score on a scale | Standard Deviation 8.1 |
| CAE-L | Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score | Week 24 | 70.8 score on a scale | Standard Deviation 8.1 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score
The SOCRATES measures motivation to reduce the use of substances. The minimum score is 10 and the maximum score is 50. A higher score indicates a higher desire to reduce drinking.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score | Screen | 46.8 score on a scale | Standard Deviation 16.8 |
| CAE-L | Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score | Week 24 | 34.8 score on a scale | Standard Deviation 18.7 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: 0.02Wilcoxon (Mann-Whitney)
Secondary
Change in the Brief Psychiatric Rating Scale (BPRS) Score
The BPRS measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Time frame: Baseline to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in the Brief Psychiatric Rating Scale (BPRS) Score | Baseline | 36.4 score on a scale | Standard Deviation 7.4 |
| CAE-L | Change in the Brief Psychiatric Rating Scale (BPRS) Score | Week 24 | 24.9 score on a scale | Standard Deviation 5.7 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in The Self-Report Habit Index (SRHI) Score
The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in The Self-Report Habit Index (SRHI) Score | Screen | 47.3 score on a scale | Standard Deviation 12.4 |
| CAE-L | Change in The Self-Report Habit Index (SRHI) Score | Week 24 | 68.5 score on a scale | Standard Deviation 13.8 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Young Mania Rating Scale (YMRS) Score
The YMRS measures symptoms of mania. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time frame: Screen to Week 24
Population: Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE).~Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAE-L | Change in Young Mania Rating Scale (YMRS) Score | Screen | 13.2 score on a scale | Standard Deviation 6.2 |
| CAE-L | Change in Young Mania Rating Scale (YMRS) Score | Baseline | 10.4 score on a scale | Standard Deviation 5.6 |
| CAE-L | Change in Young Mania Rating Scale (YMRS) Score | Week 24 | 5.6 score on a scale | Standard Deviation 4.3 |
Comparison: We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.p-value: <0.001Wilcoxon (Mann-Whitney)