Trial Outcomes & Findings for CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL) (NCT NCT03408873)

Last Updated: 2022-02-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Screen to Week 24

Results posted on

2022-02-17

Participant Flow

. 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.

Participant milestones

Participant milestones
Measure	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).
Visit 3 Assessment COMPLETED	25
Visit 3 Assessment NOT COMPLETED	1
Visit 4 Assessment STARTED	25
Visit 4 Assessment COMPLETED	23
Visit 4 Assessment NOT COMPLETED	2
Visit 5 Assessment STARTED	23
Visit 5 Assessment COMPLETED	22
Visit 1 Assessment (Baseline) STARTED	30
Visit 1 Assessment (Baseline) COMPLETED	27
Visit 1 Assessment (Baseline) NOT COMPLETED	3
Visit 2 Assessment STARTED	27
Visit 2 Assessment COMPLETED	26
Visit 2 Assessment NOT COMPLETED	1
Visit 3 Assessment STARTED	26
Visit 5 Assessment NOT COMPLETED	1
Visit 6 Assessment STARTED	22
Visit 6 Assessment COMPLETED	21
Visit 6 Assessment NOT COMPLETED	1
Visit 7 Assessment STARTED	21
Visit 7 Assessment COMPLETED	21
Visit 7 Assessment NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
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

CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAE-L n=30 Participants 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).
Age, Continuous	49.47 years STANDARD_DEVIATION 9.28 • n=39 Participants
Sex: Female, Male Female	13 Participants n=39 Participants
Sex: Female, Male Male	17 Participants n=39 Participants
Race/Ethnicity, Customized White	9 Participants n=39 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=39 Participants
Race/Ethnicity, Customized Other or Multiracial	4 Participants n=39 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=39 Participants
Race/Ethnicity, Customized Non Hispanic	29 Participants n=39 Participants
Marital Status Single, never married	17 Participants n=39 Participants
Marital Status Married	1 Participants n=39 Participants
Marital Status Separated/Divorced/Widowed	12 Participants n=39 Participants
Mean Years of Education Attained	13.63 years STANDARD_DEVIATION 2.85 • n=39 Participants
Occupation Status Full time employment/homemaker	0 Participants n=39 Participants
Occupation Status Part time employment/ homemaker or student	4 Participants n=39 Participants
Occupation Status Unemployed or on disability	25 Participants n=39 Participants
Occupation Status Other	1 Participants n=39 Participants
Number of Participants Who Live Alone	16 Participants n=39 Participants
Age at Bipolar onset	27.63 years STANDARD_DEVIATION 11.80 • n=39 Participants
Duration of bipolar illness	21.56 years STANDARD_DEVIATION 11.74 • n=39 Participants
Number of Participants With Current Substance Use Problems	6 Participants n=39 Participants
Mean lifetime psychiatric hospitalizations	3.07 hospitalizations STANDARD_DEVIATION 3.43 • n=39 Participants
Mean lifetime substance abuse hospitalizations	1.06 hospitalizations STANDARD_DEVIATION 2.00 • n=39 Participants
Number of Participants With History of Physical Abuse	16 Participants n=39 Participants
Number of Participants With History of Sexual Abuse	10 Participants n=39 Participants
Number of Participants With Family history of Mental Illness	28 Participants n=39 Participants
Number of Participants With Family history of Substance Abuse	23 Participants n=39 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=29 Participants 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).
Change in Tablets Routine Questionnaire (TRQ, Past Week) Screen	50.1 percentage of missed BD medications Standard Deviation 24.8
Change in Tablets Routine Questionnaire (TRQ, Past Week) Baseline	37.5 percentage of missed BD medications Standard Deviation 30.0
Change in Tablets Routine Questionnaire (TRQ, Past Week) Week 24	16.9 percentage of missed BD medications Standard Deviation 26.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=29 Participants 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).
Change in Tablets Routine Questionnaire (TRQ, Past Month) Screen	40.6 percentage of missed BD medications Standard Deviation 23.7
Change in Tablets Routine Questionnaire (TRQ, Past Month) Baseline	29.4 percentage of missed BD medications Standard Deviation 21.6
Change in Tablets Routine Questionnaire (TRQ, Past Month) Week 24	19.2 percentage of missed BD medications Standard Deviation 24.5

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	CAE-L n=20 Participants 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).
LAI Injection Adherence	100 percentage of adherence Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in the Brief Psychiatric Rating Scale (BPRS) Score Baseline	36.4 score on a scale Standard Deviation 7.4
Change in the Brief Psychiatric Rating Scale (BPRS) Score Week 24	24.9 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Young Mania Rating Scale (YMRS) Score Screen	13.2 score on a scale Standard Deviation 6.2
Change in Young Mania Rating Scale (YMRS) Score Baseline	10.4 score on a scale Standard Deviation 5.6
Change in Young Mania Rating Scale (YMRS) Score Week 24	5.6 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Montgomery Asberg Rating Scale (MADRS) Score Screen	24.5 score on a scale Standard Deviation 5.7
Change in Montgomery Asberg Rating Scale (MADRS) Score Baseline	18.1 score on a scale Standard Deviation 9.4
Change in Montgomery Asberg Rating Scale (MADRS) Score Week 24	7.95 score on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: Screen to Week 24

The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Clinical Global Impressions (CGI) Score Screen	4.6 score on a scale Standard Deviation 0.5
Change in Clinical Global Impressions (CGI) Score Baseline	4.1 score on a scale Standard Deviation 0.6
Change in Clinical Global Impressions (CGI) Score Week 24	2.8 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Drug Attitude Inventory (DAI) Score Screen	7.2 score on a scale Standard Deviation 1.9
Change in Drug Attitude Inventory (DAI) Score Week 24	8.1 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Attitude Towards Medication Questionnaire (AMSQ) Score Screen	7.9 score on a scale Standard Deviation 3.3
Change in Attitude Towards Medication Questionnaire (AMSQ) Score Week 24	4.0 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score Baseline	51.9 score on a scale Standard Deviation 8.1
Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score Week 24	70.8 score on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: Baseline to Week 24

The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Global Assessment of Functioning (GAF) Score Baseline	53.5 score on a scale Standard Deviation 8.1
Change in Global Assessment of Functioning (GAF) Score Week 24	70.7 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=29 Participants 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).
Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score Screen	52.9 score on a scale Standard Deviation 16.1
Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score Week 24	70.7 score on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in The Self-Report Habit Index (SRHI) Score Screen	47.3 score on a scale Standard Deviation 12.4
Change in The Self-Report Habit Index (SRHI) Score Week 24	68.5 score on a scale Standard Deviation 13.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Communication Styles Scale Score Screen	22.4 score on a scale Standard Deviation 4.2
Change in Communication Styles Scale Score Week 24	22.1 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CAE-L n=30 Participants 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).
Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score Screen	46.8 score on a scale Standard Deviation 16.8
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

Adverse Events

CAE-L

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CAE-L n=30 participants at risk 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).
Skin and subcutaneous tissue disorders Injection site pain or reaction	30.4% 7/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
Nervous system disorders Drowsiness	30.4% 7/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
Nervous system disorders Tremor	26.1% 6/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
Reproductive system and breast disorders Sexual dysfunction	13.0% 3/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
General disorders Drooling	8.7% 2/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
Musculoskeletal and connective tissue disorders Muscle Movement complaints	8.7% 2/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
Metabolism and nutrition disorders Weight gain	8.7% 2/23 • Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).

Additional Information

Joy Yala, MPH

Case Western Reserve University and University Hospitals Cleveland Medical Center

Phone: 216-368-0783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place