Clinical trial NCT00525304: A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Official title: Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: medical co-morbidity
diabetes
heart disease
respiratory illness
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-related self-efficacy and recovery orientation
timeFrame: Measured at pre- and post-intervention
measure: Medical illness self-management skills
timeFrame: Measured at pre- and post-intervention
measure: Social and communication skills during interactions with health care providers
timeFrame: Measured at pre- and post-intervention
measure: Physical and mental health status
timeFrame: Measured at pre- and post-intervention
measure: Medical service use patterns
timeFrame: Measured at pre- and post-intervention
Secondary outcomes:
measure: Medication use
timeFrame: Measured throughout the study
measure: Neurocognition
timeFrame: Measured at baseline
measure: Substance abuse
timeFrame: Measured at pre- and post-intervention
measure: Psychiatric symptoms
timeFrame: Measured at pre- and post-intervention
measure: Amount and seriousness of related comorbidities
timeFrame: Measured at pre- and post-intervention
measure: Quantitative and qualitative survey ratings
timeFrame: Measured throughout the study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Fayette Street Clinics
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Richard W. Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: