Trial Outcomes & Findings for Improving Outcomes for Individuals With Serious Mental Illness and Diabetes (NCT NCT01410357)

Last Updated: 2017-10-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

60 weeks

Results posted on

2017-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Targeted Training in Illness Management (TTIM) Participants in this arm received the TTIM intervention as well as regular treatment for their DM (diabetes mellitus) and SMI (serious mental illness) 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.	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.
Overall Study STARTED	100	100
Overall Study COMPLETED	74	76
Overall Study NOT COMPLETED	26	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Targeted Training in Illness Management (TTIM) Participants in this arm received the TTIM intervention as well as regular treatment for their DM (diabetes mellitus) and SMI (serious mental illness) 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.	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.
Overall Study Death	2	1
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	23	21

Baseline Characteristics

Improving Outcomes for Individuals With Serious Mental Illness and Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Targeted Training in Illness Management (TTIM) n=100 Participants 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.	Treatment As Usual (TAU) n=100 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.	Total n=200 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 9.7 • n=5 Participants	52.6 years STANDARD_DEVIATION 9.7 • n=7 Participants	52.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	65 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized African-American	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Education	12.7 years STANDARD_DEVIATION 2.5 • n=5 Participants	12.5 years STANDARD_DEVIATION 2.9 • n=7 Participants	12.6 years STANDARD_DEVIATION 2.7 • n=5 Participants
Health Insurance Type Private	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Health Insurance Type Medicare	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Health Insurance Type Medicaid	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Health Insurance Type Other/None	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Mini-International Neuropsychiatric Interview (MINI) Schizophrenia	29 Participants n=5 Participants	20 Participants n=7 Participants	49 Participants n=5 Participants
Mini-International Neuropsychiatric Interview (MINI) Bipolar Disorder	22 Participants n=5 Participants	34 Participants n=7 Participants	56 Participants n=5 Participants
Mini-International Neuropsychiatric Interview (MINI) Major Depressive Disorder	49 Participants n=5 Participants	46 Participants n=7 Participants	95 Participants n=5 Participants
Serious Mental Illness duration	19.1 years STANDARD_DEVIATION 12.9 • n=5 Participants	17.8 years STANDARD_DEVIATION 12.4 • n=7 Participants	18.5 years STANDARD_DEVIATION 12.6 • n=5 Participants
Diabetes mellitus duration	9.8 years STANDARD_DEVIATION 7.5 • n=5 Participants	10.3 years STANDARD_DEVIATION 8.1 • n=7 Participants	10.1 years STANDARD_DEVIATION 7.8 • n=5 Participants
AHA-defined hypertension	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
On second generation antipsychotic medication	40 Participants n=5 Participants	33 Participants n=7 Participants	73 Participants n=5 Participants
Insulin user	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Charlson Index	2.4 scores on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	2.1 scores on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	2.2 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Basic Health Literacy Screen	12.5 scores on a scale STANDARD_DEVIATION 3.0 • n=5 Participants	12.4 scores on a scale STANDARD_DEVIATION 3.3 • n=7 Participants	12.5 scores on a scale STANDARD_DEVIATION 3.2 • n=5 Participants
Clinical Global Impression	4.3 scores on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	4.3 scores on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	4.3 scores on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Montgomery Asberg Depression Rating Scale	23.1 scores on a scale STANDARD_DEVIATION 9.4 • n=5 Participants	25.0 scores on a scale STANDARD_DEVIATION 8.8 • n=7 Participants	24.1 scores on a scale STANDARD_DEVIATION 9.1 • n=5 Participants
Brief Psychiatry Rating Scale	38.7 scores on a scale STANDARD_DEVIATION 9.8 • n=5 Participants	41.3 scores on a scale STANDARD_DEVIATION 8.9 • n=7 Participants	40.0 scores on a scale STANDARD_DEVIATION 9.3 • n=5 Participants
Global Assessment of Functioning	51.8 scores on a scale STANDARD_DEVIATION 11.0 • n=5 Participants	51.4 scores on a scale STANDARD_DEVIATION 11.9 • n=7 Participants	51.6 scores on a scale STANDARD_DEVIATION 11.5 • n=5 Participants
Sheehan Disability Scale	18.0 scores on a scale STANDARD_DEVIATION 5.8 • n=5 Participants	17.8 scores on a scale STANDARD_DEVIATION 6.5 • n=7 Participants	17.9 scores on a scale STANDARD_DEVIATION 6.2 • n=5 Participants
Short-form 36 (general health status) Physical	39.4 scores on a scale STANDARD_DEVIATION 10.1 • n=5 Participants	39.8 scores on a scale STANDARD_DEVIATION 10.9 • n=7 Participants	39.6 scores on a scale STANDARD_DEVIATION 10.5 • n=5 Participants
Short-form 36 (general health status) Mental	37.2 scores on a scale STANDARD_DEVIATION 10.6 • n=5 Participants	35.6 scores on a scale STANDARD_DEVIATION 12.1 • n=7 Participants	36.4 scores on a scale STANDARD_DEVIATION 11.4 • n=5 Participants
Glycosylated hemoglobin (HbA1c)	8.2 mmol/mol STANDARD_DEVIATION 2.0 • n=5 Participants	8.0 mmol/mol STANDARD_DEVIATION 2.4 • n=7 Participants	8.2 mmol/mol STANDARD_DEVIATION 2.3 • n=5 Participants
Systolic blood pressure	135.0 mmHg STANDARD_DEVIATION 20.7 • n=5 Participants	134.5 mmHg STANDARD_DEVIATION 21.7 • n=7 Participants	134.8 mmHg STANDARD_DEVIATION 21.2 • n=5 Participants
Body Mass Index	35.4 kg/m^2 STANDARD_DEVIATION 8.0 • n=5 Participants	36.6 kg/m^2 STANDARD_DEVIATION 9.4 • n=7 Participants	36.0 kg/m^2 STANDARD_DEVIATION 8.7 • n=5 Participants

PRIMARY outcome

Timeframe: 60 weeks

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Brief Psychiatric Rating Scale (BPRS) at 60 Weeks	32.04 scores on a scale Standard Deviation 9.0	35.89 scores on a scale Standard Deviation 8.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks	15.92 scores on a scale Standard Deviation 10.0	18.55 scores on a scale Standard Deviation 8.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Clinical Global Impression (CGI) at 60 Weeks	3.24 scores on a scale Standard Deviation 1.1	4.03 scores on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Global Assessment of Functioning (GAF) at 60 Weeks	61.05 scores on a scale Standard Deviation 13.1	53.29 scores on a scale Standard Deviation 13.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Sheehan Disability Scale (SDS) at 60 Weeks	15.0 scores on a scale Standard Deviation 7.4	16.47 scores on a scale Standard Deviation 7.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component	42.05 scores on a scale Standard Deviation 11.1	39.58 scores on a scale Standard Deviation 11.4

PRIMARY outcome

Timeframe: 60 weeks

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Glycosylated Hemoglobin (HbA1c) at 60 Weeks	7.69 mmol/mol Standard Deviation 1.9	7.77 mmol/mol Standard Deviation 2.0

PRIMARY outcome

Timeframe: 60 weeks

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Systolic Blood Pressure at 60 Weeks	134.12 mmHg Standard Deviation 20.7	132.71 mmHg Standard Deviation 23.8

PRIMARY outcome

Timeframe: 60 weeks

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Body Mass Index (BMI) at 60 Weeks	36.46 kg/m^2 Standard Deviation 8.6	37.07 kg/m^2 Standard Deviation 9.8

PRIMARY outcome

Timeframe: 60 weeks

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
SF-36 Health Survey at 60 Weeks; Physical Health Component	39.65 scores on a scale Standard Deviation 11.1	40.81 scores on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Tablets Routine Questionnaire (TRQ) at 60 Weeks	17.09 percentage of days adherent Standard Deviation 30.19	18.65 percentage of days adherent Standard Deviation 30.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=76 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks	47.69 scores on a scale Standard Deviation 20.40	48.28 scores on a scale Standard Deviation 18.73

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=69 Participants 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.	Treatment As Usual (TAU) n=73 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
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	1.16 Scores on a scale Standard Deviation 2.57

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=70 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
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	15.55 scores on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=69 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks	13.80 scores on a scale Standard Deviation 3.27	13.92 scores on a scale Standard Deviation 3.86

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=70 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks	12.63 scores on a scale Standard Deviation 4.47	12.31 scores on a scale Standard Deviation 4.82

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=70 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks	14.50 scores on a scale Standard Deviation 4.71	13.85 scores on a scale Standard Deviation 4.98

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=70 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks	5.84 scores on a scale Standard Deviation 2.86	6.47 scores on a scale Standard Deviation 3.34

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=75 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks	.85 times utilized Standard Deviation 2.43	.65 times utilized Standard Deviation .94

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 weeks

Population: While 76 completed TAU, there was some missing data for this scale, resulting in 74 TAU.

The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=74 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks	.03 times utilized Standard Deviation .16	.00 times utilized Standard Deviation .00

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=73 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks	.03 time utilized Standard Deviation .16	.00 time utilized Standard Deviation .00

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=73 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks	74.57 percent correct Standard Deviation 16.59	63.02 percent correct Standard Deviation 20.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=73 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
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	43.69 scores on a scale Standard Deviation 9.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=67 Participants 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.	Treatment As Usual (TAU) n=72 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
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	26.76 scores on a scale Standard Deviation 7.48

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Targeted Training in Illness Management (TTIM) n=70 Participants 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.	Treatment As Usual (TAU) n=74 Participants Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
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	26.86 scores on a scale Standard Deviation 7.21

Adverse Events

Targeted Training in Illness Management (TTIM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Treatment As Usual (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martha Sajatovic

Case Western Reserve University School of Medicine and Neurological Institute

Phone: 216-844-2808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place