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

Case Western Reserve University

Status: Completed

Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder; Diabetes Mellitus; Depression

Treatments: Behavioral: Targeted Training in Illness Management (TTIM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01410357

R01MH085665 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Targeted Training in Illness Management (TTIM)

Experimental group

Description:

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.

Treatment:

Behavioral: Targeted Training in Illness Management (TTIM)

Treatment As Usual (TAU)

No Intervention group

Description:

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.