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A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition

Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00525304
Enrollment
100
Registered
2007-09-05
Start date
2007-09-30
Completion date
2015-05-31
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

medical co-morbidity, diabetes, heart disease, respiratory illness

Brief summary

This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.

Detailed description

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition. Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.

Interventions

BEHAVIORALSelf-management program for chronic illness

Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder * Current documented chart diagnosis of at least one chronic medical condition * Received clinic services for a minimum of 3 months prior to study entry * English-speaking * Willing to use an effective form of birth control throughout the study if sexually active

Exclusion criteria

* History of a serious neurological disorder or head trauma with loss of consciousness * Diagnosed with mental retardation or dementia * Diagnosed with end stage organ disease * Currently receiving chemotherapy and/or radiation treatment for cancer * Received psychiatric hospitalization less than 3 months prior to study entry date * Blind and/or deaf * Pregnant * Infected with HIV with a CD4 count under 350 * Diagnosis of AIDS * Diagnosis of anorexia * Problematic substance use, as defined by a mental health provider * Psychiatric instability, as defined by a mental health provider

Design outcomes

Primary

MeasureTime frame
Medical service use patternsMeasured at pre- and post-intervention
Social and communication skills during interactions with health care providersMeasured at pre- and post-intervention
Physical and mental health statusMeasured at pre- and post-intervention
Health-related self-efficacy and recovery orientationMeasured at pre- and post-intervention
Medical illness self-management skillsMeasured at pre- and post-intervention

Secondary

MeasureTime frame
Amount and seriousness of related comorbiditiesMeasured at pre- and post-intervention
Quantitative and qualitative survey ratingsMeasured throughout the study
Medication useMeasured throughout the study
NeurocognitionMeasured at baseline
Substance abuseMeasured at pre- and post-intervention
Psychiatric symptomsMeasured at pre- and post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026