Clinical trial NCT01410357: Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
Official title: Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Bipolar Disorder
Depression
Psychotic Disorders
Schizophrenia
Keywords: serious mental illness
diabetes
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: MetroHealth Medical Center
First posted: 2011-08-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS) at 60 Weeks
timeFrame: 60 weeks
measure: Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks
timeFrame: 60 weeks
measure: Clinical Global Impression (CGI) at 60 Weeks
timeFrame: 60 weeks
measure: Global Assessment of Functioning (GAF) at 60 Weeks
timeFrame: 60 weeks
measure: Sheehan Disability Scale (SDS) at 60 Weeks
timeFrame: 60 weeks
measure: SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component
timeFrame: 60 weeks
measure: Glycosylated Hemoglobin (HbA1c) at 60 Weeks
timeFrame: 60 weeks
measure: Systolic Blood Pressure at 60 Weeks
timeFrame: 60 weeks
measure: Body Mass Index (BMI) at 60 Weeks
timeFrame: 60 weeks
measure: SF-36 Health Survey at 60 Weeks; Physical Health Component
timeFrame: 60 weeks
Secondary outcomes:
measure: Tablets Routine Questionnaire (TRQ) at 60 Weeks
timeFrame: 60 weeks
measure: Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
Other outcomes:
measure: Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
measure: Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks
timeFrame: 60 weeks
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Neal V Dawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sajatovic M, Howland M, Gunzler D, Kanuch SW, Cassidy KA, McCormick R, Bauer MS, Scheidemantel T, Thomas C, Blixen C, Dawson NV. Race analysis in an African American sample with serious mental illness and comorbid diabetes. Psychiatr Rehabil J. 2018 Sep;41(3):246-252. doi: 10.1037/prj0000314.
citation: Aftab A, Bhat C, Gunzler D, Cassidy K, Thomas C, McCormick R, Dawson NV, Sajatovic M. Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial. Int J Psychiatry Med. 2018 May;53(3):126-140. doi: 10.1177/0091217417749795. Epub 2017 Dec 27.