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

Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Self-management program for chronic illness

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Fayette Street Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive a self-management program for chronic illness	Behavioral: Self-management program for chronic illness; Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
No Intervention: Usaual Care; Usual Care; no additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Health-related self-efficacy and recovery orientation	Measured at pre- and post-intervention
Medical illness self-management skills	Measured at pre- and post-intervention
Social and communication skills during interactions with health care providers	Measured at pre- and post-intervention
Physical and mental health status	Measured at pre- and post-intervention
Medical service use patterns	Measured at pre- and post-intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Medication use	Measured throughout the study
Neurocognition	Measured at baseline
Substance abuse	Measured at pre- and post-intervention
Psychiatric symptoms	Measured at pre- and post-intervention
Amount and seriousness of related comorbidities	Measured at pre- and post-intervention
Quantitative and qualitative survey ratings	Measured throughout the study

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Richard W. Goldberg, PhD, University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 4, 2007
• First Submitted That Met QC Criteria: September 4, 2007
• First Posted (Estimate): September 5, 2007

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: diabetes; heart disease; medical co-morbidity; respiratory illness
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HP-00040526; DAHBR 96-BHB; R34MH078168 (U.S. NIH Grant/Contract)