Schizophrenia
Conditions
Brief summary
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Detailed description
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.
Interventions
BEHAVIORALCustomized Adherence Enhancement for Schizophrenia (CAE-S)
6-session series spaced out over approximately 6-10 weeks
eTAU participants will view a pre-taped series of 6 videos
Sponsors
Merck Sharp & Dohme LLC
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI) * Prescribed an antipsychotic medication for treatment of schizophrenia * Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month) * Ability to be rated on psychiatric rating scales * 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 * Able to provide written, informed consent to study participation * Has access to electronic device and internet to complete sessions conducted on videoconferencing platform
Exclusion criteria
* Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence) * Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial * 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 * Immediate risk of harm to self or others * Female who is currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks | 12 weeks |
| Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | 12 weeks | The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia |
| Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks | 12 weeks | The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence. |
| Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | 12 weeks | The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence. |
| Change in eCAP Use in the Past Week at 12 Weeks | 12 weeks | Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use.
Customized Adherence Enhancement for Schizophrenia (CAE-S): 6-session series spaced out over approximately 6-10 weeks | 19 |
| Enhanced Treatment as Usual (eTAU) To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have.
Enhanced Treatment as Usual (eTAU): eTAU participants will view a pre-taped series of 6 videos | 17 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Customized Adherence Enhancement for Schizophrenia (CAE-S) | Enhanced Treatment as Usual (eTAU) | Total |
|---|---|---|---|
| Age at schizophrenia diagnosis | 23.8 years STANDARD_DEVIATION 9.8 | 26.6 years STANDARD_DEVIATION 8.3 | 25.1 years STANDARD_DEVIATION 9.1 |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 10.9 | 47.4 years STANDARD_DEVIATION 12.9 | 44.9 years STANDARD_DEVIATION 12 |
| BMI | 32.7 kg/m^2 STANDARD_DEVIATION 5.3 | 33.6 kg/m^2 STANDARD_DEVIATION 8 | 33.2 kg/m^2 STANDARD_DEVIATION 6.6 |
| Employment Status Employed | 7 Participants | 6 Participants | 13 Participants |
| Employment Status Unemployed | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 17 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Status Medicaid | 10 Participants | 12 Participants | 22 Participants |
| Health Insurance Status Medicare | 9 Participants | 9 Participants | 18 Participants |
| Health Insurance Status No Insurance | 2 Participants | 0 Participants | 2 Participants |
| Health Insurance Status Other | 1 Participants | 0 Participants | 1 Participants |
| Health Insurance Status Private | 2 Participants | 1 Participants | 3 Participants |
| Health resource use, past 3 months All-cause hospitalizations | 0.05 number of events STANDARD_DEVIATION 0.2 | 0.24 number of events STANDARD_DEVIATION 0.8 | 0.14 number of events STANDARD_DEVIATION 0.5 |
| Health resource use, past 3 months Any outpatient visits | 7.5 number of events STANDARD_DEVIATION 9.6 | 6.4 number of events STANDARD_DEVIATION 4.3 | 7 number of events STANDARD_DEVIATION 7.5 |
| Health resource use, past 3 months Emergency room / urgent care | 1.3 number of events STANDARD_DEVIATION 3.4 | 0.9 number of events STANDARD_DEVIATION 1.2 | 1.1 number of events STANDARD_DEVIATION 2.6 |
| History of physical abuse | 10 Participants | 8 Participants | 18 Participants |
| History of sexual abuse | 9 Participants | 7 Participants | 16 Participants |
| Hospitalizations (lifetime) For schizophrenia | 6.7 Number of hospitalizations STANDARD_DEVIATION 7 | 4.9 Number of hospitalizations STANDARD_DEVIATION 3.3 | 5.6 Number of hospitalizations STANDARD_DEVIATION 5.5 |
| Hospitalizations (lifetime) For substance abuse | 2.6 Number of hospitalizations STANDARD_DEVIATION 1.2 | 3 Number of hospitalizations | 2.8 Number of hospitalizations STANDARD_DEVIATION 1 |
| Martial Status Married | 4 Participants | 0 Participants | 4 Participants |
| Martial Status Previously Married (Separated/Divorced/Widowed) | 4 Participants | 3 Participants | 7 Participants |
| Martial Status Single, Never Married | 11 Participants | 14 Participants | 25 Participants |
| PANSS total score | 61.7 units on a scale STANDARD_DEVIATION 9.8 | 66.6 units on a scale STANDARD_DEVIATION 8.5 | 64 units on a scale STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Non-White | 9 Participants | 9 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
| Years of Education | 13.4 years STANDARD_DEVIATION 2.4 | 13.5 years STANDARD_DEVIATION 2.2 | 13.4 years STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 2 / 19 | 0 / 17 |
Outcome results
Primary
Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks | 4.89 Number of sessions attended | Standard Deviation 1.9 |
Primary
Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks
Time frame: 12 weeks
Population: Only 16 of the 19 participants randomized to CAE-S provided data on satisfaction with CAE-S
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks | 93.8 percentage of CAE-S participants |
Secondary
Change in eCAP Use in the Past Week at 12 Weeks
Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Time frame: 12 weeks
Population: We only have eCAP data on 11 participants in the CAE-S group and 8 participants in the eTAU group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in eCAP Use in the Past Week at 12 Weeks | Baseline | 20.8 Percentage of missed doses | Standard Deviation 34 |
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in eCAP Use in the Past Week at 12 Weeks | Week 12 | 33.8 Percentage of missed doses | Standard Deviation 36.9 |
| Enhanced Treatment as Usual (eTAU) | Change in eCAP Use in the Past Week at 12 Weeks | Baseline | 32.1 Percentage of missed doses | Standard Deviation 32.2 |
| Enhanced Treatment as Usual (eTAU) | Change in eCAP Use in the Past Week at 12 Weeks | Week 12 | 50 Percentage of missed doses | Standard Deviation 35 |
Secondary
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks
The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia
Time frame: 12 weeks
Population: Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | Baseline | 60.9 units on a scale | Standard Deviation 10.5 |
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | Week 12 | 53.8 units on a scale | Standard Deviation 9 |
| Enhanced Treatment as Usual (eTAU) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | Baseline | 66.0 units on a scale | Standard Deviation 9.7 |
| Enhanced Treatment as Usual (eTAU) | Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | Week 12 | 54.2 units on a scale | Standard Deviation 11.2 |
Secondary
Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.
Time frame: 12 weeks
Population: Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | Baseline | 11.9 Percentage of days with missed doses | Standard Deviation 20.7 |
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | Week 12 | 7.4 Percentage of days with missed doses | Standard Deviation 8.7 |
| Enhanced Treatment as Usual (eTAU) | Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | Baseline | 7.7 Percentage of days with missed doses | Standard Deviation 8.6 |
| Enhanced Treatment as Usual (eTAU) | Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | Week 12 | 5.4 Percentage of days with missed doses | Standard Deviation 7 |
Secondary
Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.
Time frame: 12 weeks
Population: Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks | Baseline | 13.4 Percentage of days with missed doses | Standard Deviation 16.5 |
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks | Week 12 | 17.9 Percentage of days with missed doses | Standard Deviation 28 |
| Enhanced Treatment as Usual (eTAU) | Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks | Baseline | 13.2 Percentage of days with missed doses | Standard Deviation 10.9 |
| Enhanced Treatment as Usual (eTAU) | Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks | Week 12 | 8.8 Percentage of days with missed doses | Standard Deviation 11 |