N/A N=200 Randomized Supportive Care

Improving Outcomes for Individuals With Serious Mental Illness and Diabetes

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

Bottom Line

View on ClinicalTrials.gov: NCT01410357 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Brief Psychiatric Rating Scale (BPRS) at 60 Weeks — 32.04; 35.89 scores on a scale — p=.785

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Targeted Training in Illness Management (TTIM) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Case Western Reserve University
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Brief Psychiatric Rating Scale (BPRS) at 60 Weeks	32.04; 35.89	.785
PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks	15.92; 18.55	.016 sig
PRIMARY Clinical Global Impression (CGI) at 60 Weeks	3.24; 4.03	<0.001 sig
PRIMARY Global Assessment of Functioning (GAF) at 60 Weeks	61.05; 53.29	.003 sig
PRIMARY Sheehan Disability Scale (SDS) at 60 Weeks	15.0; 16.47	.086
PRIMARY SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component	42.05; 39.58	.872
PRIMARY Glycosylated Hemoglobin (HbA1c) at 60 Weeks	7.69; 7.77	.662
PRIMARY Systolic Blood Pressure at 60 Weeks	134.12; 132.71	.633
PRIMARY Body Mass Index (BMI) at 60 Weeks	36.46; 37.07	.175
PRIMARY SF-36 Health Survey at 60 Weeks; Physical Health Component	39.65; 40.81	.680
SECONDARY Tablets Routine Questionnaire (TRQ) at 60 Weeks	17.09; 18.65	.407
SECONDARY Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks	47.69; 48.28	.870
SECONDARY Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks	1.93; 1.16	.707
SECONDARY Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks	15.41; 15.55	.838
SECONDARY Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks	13.80; 13.92	.853
SECONDARY Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks	12.63; 12.31	.853
SECONDARY Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks	14.50; 13.85	.510
SECONDARY Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks	5.84; 6.47	.573

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.

Eligibility Criteria

Inclusion Criteria

Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
Have DM based upon either previous diagnosis or laboratory values
Be ≥ 18 years of age
Be able to communicate in English
Be able to provide written, informed consent to participation.

Exclusion Criteria

Actively suicidal/homicidal
Unable to be rated on study rating scales
Demented
Pregnant
Unable to provide informed consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01410357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.