Improving Outcomes for Individuals With Serious Mental Illness and Diabetes (TTIM)

• Change from Baseline in Brief Psychiatric Rating Scale (BPRS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Clinical Global Impression (CGI) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Global Assessment of Functioning (GAF) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Sheehan Disability Scale (SDS) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in SF-36 Health Survey at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Blood Pressure at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Body Mass Index (BMI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Heart Rate at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]

• Change from Baseline in Brief Psychiatric Rating Scale (BPRS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Montgomery Asburg Depression Rating Scale (MADRS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Clinical Global Impression (CGI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Global Assessment of Functioning (GAF) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Sheehan Disability Scale (SDS) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Blood Pressure at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Body Mass Index (BMI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in SF-12 Health Survey at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]

• Change from Baseline in Tablets Routine Questionnaire (TRQ) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in The Alcohol Use Disorders Identification Test (AUDIT) at 13 weeks, 30 weeks, and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Smoking Index at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Mental Health Resource Utilization at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Medical Care Resource Utilization at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Drug Abuse Screening Test (DAST-10) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]

• Change from Baseline in Tablets Routine Questionnaire (TRQ) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Addiction Severity Index (ASI) at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
  substance abuse portion only
• Change from Baseline in Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 30 weeks and 60 weeks [ Time Frame: Baseline, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]

• Change from Baseline in Michigan Diabetes Research and Training Center's Brief Diabetes Knowledge Test at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Perceived Diabetes Self-Management Scale (PDSMS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Perceived Mental Health Self-Management Scale (PMHSMS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Perceived Therapeutice Efficacy Scale for Diabetes (PTES for DM) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Insight and Treatment Attitudes Questionnaire (ITAQ) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Multi-dimensional Scale of Perceived Social Support (MSPSS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Internalized Stigma for Mental Illness Scale (ISMI) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Barriers to Self-Care Scale (BSCS) at 13 weeks, 30 weeks and 60 weeks [ Time Frame: Baseline, 13 weeks, 30 weeks, 60 weeks ] [ Designated as safety issue: No ]

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.

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.

• Diabetes Mellitus
• Bipolar Disorder
• Depression
• Psychotic Disorders
• Schizophrenia

• Experimental: Targeted Training in Illness Management (TTIM)
  Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers.
  Intervention: Behavioral: Targeted Training in Illness Management (TTIM)
• No Intervention: Treatment As Usual (TAU)
  Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention.

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.

• National Institute of Mental Health (NIMH)
• MetroHealth System