Bipolar Disorder, Depression, Diabetes Mellitus, Psychotic Disorders, Schizophrenia
Conditions
Keywords
serious mental illness, diabetes
Brief summary
This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.
Detailed description
This project will test a novel intervention, Targeted Training in Illness Management (TTIM), intended to improve both serious mental illness (SMI) and diabetes mellitus (DM) self-management in 100 individuals with SMI-DM vs. 100 individuals with SMI-DM receiving treatment as usual (TAU). The intervention will be conducted in a safety-net health system primary care setting and will be conducted as a randomized controlled trial (RCT). The primary effects of TTIM will be assessed with respect to SMI symptoms, Functional Status/Role Impairment, General Health Status, and DM outcomes. Secondary outcomes include adherence to psychotropic and DM medication, and engagement in healthy behaviors. This assessment will include quantitative assessment of facilitators/barriers targeted by the proposed intervention as well as a supplemental qualitative assessment. The qualitative assessments will include input from patients and interventionists. Specific aims for the qualitative analysis are to validate findings from the RCT, expand understanding of key active ingredients of TTIM, and provide information to inform future studies on individuals with SMI and related medical conditions.
Interventions
BEHAVIORALTargeted Training in Illness Management (TTIM)
This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management.
Sponsors
National Institute of Mental Health (NIMH)
MetroHealth Medical Center
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression 2. Have DM based upon either previous diagnosis or laboratory values 3. Be ≥ 18 years of age 4. Be able to communicate in English 5. Be able to provide written, informed consent to participation.
Exclusion criteria
1. Actively suicidal/homicidal 2. Unable to be rated on study rating scales 3. Demented 4. Pregnant 5. Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated Hemoglobin (HbA1c) at 60 Weeks | 60 weeks | — |
| SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component | 60 weeks | The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function. |
| Global Assessment of Functioning (GAF) at 60 Weeks | 60 weeks | The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning. |
| Sheehan Disability Scale (SDS) at 60 Weeks | 60 weeks | The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10. |
| SF-36 Health Survey at 60 Weeks; Physical Health Component | 60 weeks | The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function. |
| Brief Psychiatric Rating Scale (BPRS) at 60 Weeks | 60 weeks | The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses. |
| Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks | 60 weeks | The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression. |
| Clinical Global Impression (CGI) at 60 Weeks | 60 weeks | The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology. |
| Body Mass Index (BMI) at 60 Weeks | 60 weeks | — |
| Systolic Blood Pressure at 60 Weeks | 60 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks | 60 weeks | The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness. |
| Tablets Routine Questionnaire (TRQ) at 60 Weeks | 60 weeks | The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications. |
| Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks | 60 weeks | The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50. |
| Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks | 60 weeks | The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment. |
| Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks | 60 weeks | The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness. |
| Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness. |
| Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness. |
| Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD. |
| Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The Perceived Mental Health Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to mental health. |
| Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks | 60 weeks | The Perceived Diabetes Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Items 1, 2, 6, and 7 are reverse coded. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to diabetes. |
| Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The Multidimensional Scale of Perceived Social Support is a 12 question Likert scale, with each item ranging from 1-5. Total scores range from 12-60, with higher scores indicating more perceived social support. |
| Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks | 60 weeks | The diabetes knowledge score has 23 questions which assess how much knowledge one has about diabetes. They are in multiple choice format, with 4 choices, and only one is correct. The total amount correct is added up, and then calculated into a percentage of answers correct. |
| Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD. |
| Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks | 60 weeks | The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Targeted Training in Illness Management (TTIM) Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.
Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management. | 100 |
| Treatment As Usual (TAU) Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 23 | 21 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Treatment As Usual (TAU) | Targeted Training in Illness Management (TTIM) |
|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 9.5 | 52.6 years STANDARD_DEVIATION 9.7 | 52.8 years STANDARD_DEVIATION 9.7 |
| AHA-defined hypertension | 87 Participants | 42 Participants | 45 Participants |
| Basic Health Literacy Screen | 12.5 scores on a scale STANDARD_DEVIATION 3.2 | 12.4 scores on a scale STANDARD_DEVIATION 3.3 | 12.5 scores on a scale STANDARD_DEVIATION 3 |
| Body Mass Index | 36.0 kg/m^2 STANDARD_DEVIATION 8.7 | 36.6 kg/m^2 STANDARD_DEVIATION 9.4 | 35.4 kg/m^2 STANDARD_DEVIATION 8 |
| Brief Psychiatry Rating Scale | 40.0 scores on a scale STANDARD_DEVIATION 9.3 | 41.3 scores on a scale STANDARD_DEVIATION 8.9 | 38.7 scores on a scale STANDARD_DEVIATION 9.8 |
| Charlson Index | 2.2 scores on a scale STANDARD_DEVIATION 1.6 | 2.1 scores on a scale STANDARD_DEVIATION 1.5 | 2.4 scores on a scale STANDARD_DEVIATION 1.7 |
| Clinical Global Impression | 4.3 scores on a scale STANDARD_DEVIATION 0.9 | 4.3 scores on a scale STANDARD_DEVIATION 0.9 | 4.3 scores on a scale STANDARD_DEVIATION 1 |
| Diabetes mellitus duration | 10.1 years STANDARD_DEVIATION 7.8 | 10.3 years STANDARD_DEVIATION 8.1 | 9.8 years STANDARD_DEVIATION 7.5 |
| Education | 12.6 years STANDARD_DEVIATION 2.7 | 12.5 years STANDARD_DEVIATION 2.9 | 12.7 years STANDARD_DEVIATION 2.5 |
| Global Assessment of Functioning | 51.6 scores on a scale STANDARD_DEVIATION 11.5 | 51.4 scores on a scale STANDARD_DEVIATION 11.9 | 51.8 scores on a scale STANDARD_DEVIATION 11 |
| Glycosylated hemoglobin (HbA1c) | 8.2 mmol/mol STANDARD_DEVIATION 2.3 | 8.0 mmol/mol STANDARD_DEVIATION 2.4 | 8.2 mmol/mol STANDARD_DEVIATION 2 |
| Health Insurance Type Medicaid | 95 Participants | 47 Participants | 48 Participants |
| Health Insurance Type Medicare | 69 Participants | 34 Participants | 35 Participants |
| Health Insurance Type Other/None | 29 Participants | 17 Participants | 12 Participants |
| Health Insurance Type Private | 7 Participants | 2 Participants | 5 Participants |
| Insulin user | 88 Participants | 45 Participants | 43 Participants |
| Mini-International Neuropsychiatric Interview (MINI) Bipolar Disorder | 56 Participants | 34 Participants | 22 Participants |
| Mini-International Neuropsychiatric Interview (MINI) Major Depressive Disorder | 95 Participants | 46 Participants | 49 Participants |
| Mini-International Neuropsychiatric Interview (MINI) Schizophrenia | 49 Participants | 20 Participants | 29 Participants |
| Montgomery Asberg Depression Rating Scale | 24.1 scores on a scale STANDARD_DEVIATION 9.1 | 25.0 scores on a scale STANDARD_DEVIATION 8.8 | 23.1 scores on a scale STANDARD_DEVIATION 9.4 |
| On second generation antipsychotic medication | 73 Participants | 33 Participants | 40 Participants |
| Race/Ethnicity, Customized African-American | 107 Participants | 55 Participants | 52 Participants |
| Race/Ethnicity, Customized Caucasian | 74 Participants | 36 Participants | 38 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 19 Participants | 9 Participants | 10 Participants |
| Region of Enrollment United States | 200 Participants | 100 Participants | 100 Participants |
| Serious Mental Illness duration | 18.5 years STANDARD_DEVIATION 12.6 | 17.8 years STANDARD_DEVIATION 12.4 | 19.1 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 128 Participants | 65 Participants | 63 Participants |
| Sex: Female, Male Male | 72 Participants | 35 Participants | 37 Participants |
| Sheehan Disability Scale | 17.9 scores on a scale STANDARD_DEVIATION 6.2 | 17.8 scores on a scale STANDARD_DEVIATION 6.5 | 18.0 scores on a scale STANDARD_DEVIATION 5.8 |
| Short-form 36 (general health status) Mental | 36.4 scores on a scale STANDARD_DEVIATION 11.4 | 35.6 scores on a scale STANDARD_DEVIATION 12.1 | 37.2 scores on a scale STANDARD_DEVIATION 10.6 |
| Short-form 36 (general health status) Physical | 39.6 scores on a scale STANDARD_DEVIATION 10.5 | 39.8 scores on a scale STANDARD_DEVIATION 10.9 | 39.4 scores on a scale STANDARD_DEVIATION 10.1 |
| Systolic blood pressure | 134.8 mmHg STANDARD_DEVIATION 21.2 | 134.5 mmHg STANDARD_DEVIATION 21.7 | 135.0 mmHg STANDARD_DEVIATION 20.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 100 | 1 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Body Mass Index (BMI) at 60 Weeks
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Body Mass Index (BMI) at 60 Weeks | 36.46 kg/m^2 | Standard Deviation 8.6 |
| Treatment As Usual (TAU) | Body Mass Index (BMI) at 60 Weeks | 37.07 kg/m^2 | Standard Deviation 9.8 |
p-value: 0.175Mixed Models Analysis
Primary
Brief Psychiatric Rating Scale (BPRS) at 60 Weeks
The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Brief Psychiatric Rating Scale (BPRS) at 60 Weeks | 32.04 scores on a scale | Standard Deviation 9 |
| Treatment As Usual (TAU) | Brief Psychiatric Rating Scale (BPRS) at 60 Weeks | 35.89 scores on a scale | Standard Deviation 8.7 |
p-value: 0.785Mixed Models Analysis
Primary
Clinical Global Impression (CGI) at 60 Weeks
The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Clinical Global Impression (CGI) at 60 Weeks | 3.24 scores on a scale | Standard Deviation 1.1 |
| Treatment As Usual (TAU) | Clinical Global Impression (CGI) at 60 Weeks | 4.03 scores on a scale | Standard Deviation 1.1 |
p-value: <0.001Mixed Models Analysis
Primary
Global Assessment of Functioning (GAF) at 60 Weeks
The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Global Assessment of Functioning (GAF) at 60 Weeks | 61.05 scores on a scale | Standard Deviation 13.1 |
| Treatment As Usual (TAU) | Global Assessment of Functioning (GAF) at 60 Weeks | 53.29 scores on a scale | Standard Deviation 13.3 |
p-value: 0.003Mixed Models Analysis
Primary
Glycosylated Hemoglobin (HbA1c) at 60 Weeks
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Glycosylated Hemoglobin (HbA1c) at 60 Weeks | 7.69 mmol/mol | Standard Deviation 1.9 |
| Treatment As Usual (TAU) | Glycosylated Hemoglobin (HbA1c) at 60 Weeks | 7.77 mmol/mol | Standard Deviation 2 |
p-value: 0.662Mixed Models Analysis
Primary
Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks
The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks | 15.92 scores on a scale | Standard Deviation 10 |
| Treatment As Usual (TAU) | Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks | 18.55 scores on a scale | Standard Deviation 8.8 |
p-value: 0.016Mixed Models Analysis
Primary
SF-36 Health Survey at 60 Weeks; Physical Health Component
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | SF-36 Health Survey at 60 Weeks; Physical Health Component | 39.65 scores on a scale | Standard Deviation 11.1 |
| Treatment As Usual (TAU) | SF-36 Health Survey at 60 Weeks; Physical Health Component | 40.81 scores on a scale | Standard Deviation 9.3 |
p-value: 0.68Mixed Models Analysis
Primary
SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component | 42.05 scores on a scale | Standard Deviation 11.1 |
| Treatment As Usual (TAU) | SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component | 39.58 scores on a scale | Standard Deviation 11.4 |
p-value: 0.872Mixed Models Analysis
Primary
Sheehan Disability Scale (SDS) at 60 Weeks
The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Sheehan Disability Scale (SDS) at 60 Weeks | 15.0 scores on a scale | Standard Deviation 7.4 |
| Treatment As Usual (TAU) | Sheehan Disability Scale (SDS) at 60 Weeks | 16.47 scores on a scale | Standard Deviation 7.1 |
p-value: 0.086Mixed Models Analysis
Primary
Systolic Blood Pressure at 60 Weeks
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Systolic Blood Pressure at 60 Weeks | 134.12 mmHg | Standard Deviation 20.7 |
| Treatment As Usual (TAU) | Systolic Blood Pressure at 60 Weeks | 132.71 mmHg | Standard Deviation 23.8 |
p-value: 0.633Mixed Models Analysis
Secondary
Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks
The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 73 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks | 1.93 Scores on a scale | Standard Deviation 5.23 |
| Treatment As Usual (TAU) | Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks | 1.16 Scores on a scale | Standard Deviation 2.57 |
p-value: 0.707Mixed Models Analysis
Secondary
Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks | 12.63 scores on a scale | Standard Deviation 4.47 |
| Treatment As Usual (TAU) | Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks | 12.31 scores on a scale | Standard Deviation 4.82 |
p-value: 0.853Mixed Models Analysis
Secondary
Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks | 15.41 scores on a scale | Standard Deviation 4.91 |
| Treatment As Usual (TAU) | Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks | 15.55 scores on a scale | Standard Deviation 6.07 |
p-value: 0.838Mixed Models Analysis
Secondary
Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks | 14.50 scores on a scale | Standard Deviation 4.71 |
| Treatment As Usual (TAU) | Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks | 13.85 scores on a scale | Standard Deviation 4.98 |
p-value: 0.51Mixed Models Analysis
Secondary
Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks | 13.80 scores on a scale | Standard Deviation 3.27 |
| Treatment As Usual (TAU) | Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks | 13.92 scores on a scale | Standard Deviation 3.86 |
p-value: 0.853Mixed Models Analysis
Secondary
Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks | 5.84 scores on a scale | Standard Deviation 2.86 |
| Treatment As Usual (TAU) | Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks | 6.47 scores on a scale | Standard Deviation 3.34 |
p-value: 0.573Mixed Models Analysis
Secondary
Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks | 47.69 scores on a scale | Standard Deviation 20.4 |
| Treatment As Usual (TAU) | Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks | 48.28 scores on a scale | Standard Deviation 18.73 |
p-value: 0.87Mixed Models Analysis
Secondary
Tablets Routine Questionnaire (TRQ) at 60 Weeks
The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications.
Time frame: 60 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Tablets Routine Questionnaire (TRQ) at 60 Weeks | 17.09 percentage of days adherent | Standard Deviation 30.19 |
| Treatment As Usual (TAU) | Tablets Routine Questionnaire (TRQ) at 60 Weeks | 18.65 percentage of days adherent | Standard Deviation 30.1 |
p-value: 0.407Mixed Models Analysis
Other Pre-specified
Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks
The diabetes knowledge score has 23 questions which assess how much knowledge one has about diabetes. They are in multiple choice format, with 4 choices, and only one is correct. The total amount correct is added up, and then calculated into a percentage of answers correct.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks | 74.57 percent correct | Standard Deviation 16.59 |
| Treatment As Usual (TAU) | Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks | 63.02 percent correct | Standard Deviation 20.58 |
p-value: <0.001Mixed Models Analysis
Other Pre-specified
Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks
The Multidimensional Scale of Perceived Social Support is a 12 question Likert scale, with each item ranging from 1-5. Total scores range from 12-60, with higher scores indicating more perceived social support.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks | 44.11 scores on a scale | Standard Deviation 8.45 |
| Treatment As Usual (TAU) | Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks | 43.69 scores on a scale | Standard Deviation 9.54 |
p-value: 0.878Mixed Models Analysis
Other Pre-specified
Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks
The Perceived Diabetes Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Items 1, 2, 6, and 7 are reverse coded. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to diabetes.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 67 TTIM and 72 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks | 29.66 scores on a scale | Standard Deviation 4.74 |
| Treatment As Usual (TAU) | Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks | 26.76 scores on a scale | Standard Deviation 7.48 |
p-value: 0.014Mixed Models Analysis
Other Pre-specified
Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks
The Perceived Mental Health Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to mental health.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks | 28.43 scores on a scale | Standard Deviation 5.76 |
| Treatment As Usual (TAU) | Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks | 26.86 scores on a scale | Standard Deviation 7.21 |
p-value: 0.227Mixed Models Analysis
Other Pre-specified
Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks
The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.
Time frame: 60 weeks
Population: While 76 completed TAU, there was some missing data for this scale, resulting in 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks | .03 times utilized | Standard Deviation 0.16 |
| Treatment As Usual (TAU) | Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks | .00 times utilized | Standard Deviation 0 |
p-value: 0.156Mixed Models Analysis
Other Pre-specified
Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks
The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks | .03 time utilized | Standard Deviation 0.16 |
| Treatment As Usual (TAU) | Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks | .00 time utilized | Standard Deviation 0 |
p-value: 0.156Mixed Models Analysis
Other Pre-specified
Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks
The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.
Time frame: 60 weeks
Population: While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 74 TTIM and 75 TAU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Training in Illness Management (TTIM) | Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks | .85 times utilized | Standard Deviation 2.43 |
| Treatment As Usual (TAU) | Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks | .65 times utilized | Standard Deviation 0.94 |
p-value: 0.758Mixed Models Analysis