Trial Outcomes & Findings for CAE for Poorly Adherent Individuals With Schizophrenia (NCT NCT06061952)
NCT ID: NCT06061952
Last Updated: 2025-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
Baseline characteristics by cohort
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=19 Participants
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
|
Enhanced Treatment as Usual (eTAU)
n=17 Participants
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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 10.9 • n=19 Participants
|
47.4 years
STANDARD_DEVIATION 12.9 • n=17 Participants
|
44.9 years
STANDARD_DEVIATION 12.0 • n=36 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=19 Participants
|
12 Participants
n=17 Participants
|
25 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=19 Participants
|
5 Participants
n=17 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=19 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=19 Participants
|
17 Participants
n=17 Participants
|
34 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=19 Participants
|
8 Participants
n=17 Participants
|
18 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
9 Participants
n=19 Participants
|
9 Participants
n=17 Participants
|
18 Participants
n=36 Participants
|
|
Martial Status
Single, Never Married
|
11 Participants
n=19 Participants
|
14 Participants
n=17 Participants
|
25 Participants
n=36 Participants
|
|
Martial Status
Married
|
4 Participants
n=19 Participants
|
0 Participants
n=17 Participants
|
4 Participants
n=36 Participants
|
|
Martial Status
Previously Married (Separated/Divorced/Widowed)
|
4 Participants
n=19 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=36 Participants
|
|
Years of Education
|
13.4 years
STANDARD_DEVIATION 2.4 • n=19 Participants
|
13.5 years
STANDARD_DEVIATION 2.2 • n=17 Participants
|
13.4 years
STANDARD_DEVIATION 2.3 • n=36 Participants
|
|
Employment Status
Employed
|
7 Participants
n=19 Participants
|
6 Participants
n=17 Participants
|
13 Participants
n=36 Participants
|
|
Employment Status
Unemployed
|
12 Participants
n=19 Participants
|
11 Participants
n=17 Participants
|
23 Participants
n=36 Participants
|
|
Health Insurance Status
Medicaid
|
10 Participants
n=19 Participants
|
12 Participants
n=17 Participants
|
22 Participants
n=36 Participants
|
|
Health Insurance Status
Medicare
|
9 Participants
n=19 Participants
|
9 Participants
n=17 Participants
|
18 Participants
n=36 Participants
|
|
Health Insurance Status
Private
|
2 Participants
n=19 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=36 Participants
|
|
Health Insurance Status
No Insurance
|
2 Participants
n=19 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=36 Participants
|
|
Health Insurance Status
Other
|
1 Participants
n=19 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=36 Participants
|
|
Age at schizophrenia diagnosis
|
23.8 years
STANDARD_DEVIATION 9.8 • n=19 Participants
|
26.6 years
STANDARD_DEVIATION 8.3 • n=17 Participants
|
25.1 years
STANDARD_DEVIATION 9.1 • n=36 Participants
|
|
BMI
|
32.7 kg/m^2
STANDARD_DEVIATION 5.3 • n=19 Participants
|
33.6 kg/m^2
STANDARD_DEVIATION 8.0 • n=17 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 6.6 • n=36 Participants
|
|
History of physical abuse
|
10 Participants
n=19 Participants
|
8 Participants
n=17 Participants
|
18 Participants
n=36 Participants
|
|
History of sexual abuse
|
9 Participants
n=19 Participants
|
7 Participants
n=17 Participants
|
16 Participants
n=36 Participants
|
|
PANSS total score
|
61.7 units on a scale
STANDARD_DEVIATION 9.8 • n=19 Participants
|
66.6 units on a scale
STANDARD_DEVIATION 8.5 • n=17 Participants
|
64 units on a scale
STANDARD_DEVIATION 9.4 • n=36 Participants
|
|
Hospitalizations (lifetime)
For schizophrenia
|
6.7 Number of hospitalizations
STANDARD_DEVIATION 7.0 • n=19 Participants • There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
|
4.9 Number of hospitalizations
STANDARD_DEVIATION 3.3 • n=17 Participants • There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
|
5.6 Number of hospitalizations
STANDARD_DEVIATION 5.5 • n=36 Participants • There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
|
|
Hospitalizations (lifetime)
For substance abuse
|
2.6 Number of hospitalizations
STANDARD_DEVIATION 1.2 • n=3 Participants • There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
|
3 Number of hospitalizations
n=1 Participants • There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
|
2.8 Number of hospitalizations
STANDARD_DEVIATION 1 • n=4 Participants • There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use.
|
|
Health resource use, past 3 months
All-cause hospitalizations
|
0.05 number of events
STANDARD_DEVIATION 0.2 • n=19 Participants
|
0.24 number of events
STANDARD_DEVIATION 0.8 • n=17 Participants
|
0.14 number of events
STANDARD_DEVIATION 0.5 • n=36 Participants
|
|
Health resource use, past 3 months
Emergency room / urgent care
|
1.3 number of events
STANDARD_DEVIATION 3.4 • n=19 Participants
|
0.9 number of events
STANDARD_DEVIATION 1.2 • n=17 Participants
|
1.1 number of events
STANDARD_DEVIATION 2.6 • n=36 Participants
|
|
Health resource use, past 3 months
Any outpatient visits
|
7.5 number of events
STANDARD_DEVIATION 9.6 • n=19 Participants
|
6.4 number of events
STANDARD_DEVIATION 4.3 • n=17 Participants
|
7 number of events
STANDARD_DEVIATION 7.5 • n=36 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=19 Participants
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
|
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
|
|---|---|---|
|
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 outcome
Timeframe: 12 weeksPopulation: Only 16 of the 19 participants randomized to CAE-S provided data on satisfaction with CAE-S
Outcome measures
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=16 Participants
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
|
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
|
|---|---|---|
|
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 outcome
Timeframe: 12 weeksPopulation: Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data
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
Outcome measures
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=16 Participants
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
|
Enhanced Treatment as Usual (eTAU)
n=13 Participants
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
|
|---|---|---|
|
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
|
66.0 units on a scale
Standard Deviation 9.7
|
|
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 9.0
|
54.2 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data
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.
Outcome measures
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=16 Participants
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
|
Enhanced Treatment as Usual (eTAU)
n=13 Participants
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
|
|---|---|---|
|
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
|
13.2 Percentage of days with missed doses
Standard Deviation 10.9
|
|
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 28.0
|
8.8 Percentage of days with missed doses
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data
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.
Outcome measures
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=16 Participants
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
|
Enhanced Treatment as Usual (eTAU)
n=13 Participants
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
|
|---|---|---|
|
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
|
7.7 Percentage of days with missed doses
Standard Deviation 8.6
|
|
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
|
5.4 Percentage of days with missed doses
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: We only have eCAP data on 11 participants in the CAE-S group and 8 participants in the eTAU group
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.
Outcome measures
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=11 Participants
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
|
Enhanced Treatment as Usual (eTAU)
n=8 Participants
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
|
|---|---|---|
|
Change in eCAP Use in the Past Week at 12 Weeks
Baseline
|
20.8 Percentage of missed doses
Standard Deviation 34.0
|
32.1 Percentage of missed doses
Standard Deviation 32.2
|
|
Change in eCAP Use in the Past Week at 12 Weeks
Week 12
|
33.8 Percentage of missed doses
Standard Deviation 36.9
|
50 Percentage of missed doses
Standard Deviation 35.0
|
Adverse Events
Customized Adherence Enhancement for Schizophrenia (CAE-S)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual (eTAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Customized Adherence Enhancement for Schizophrenia (CAE-S)
n=19 participants at risk
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
|
Enhanced Treatment as Usual (eTAU)
n=17 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to pneumonia
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
|
Endocrine disorders
Hospitalization due to diabetes complications
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
|
Renal and urinary disorders
Hospitalization due to renal complications
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
|
Psychiatric disorders
Hospitalization due to psychiatric symptoms
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Martha Sajatovic, MD
University Hospitals Cleveland Medical Center
Phone: 216-844-2808
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place