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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525304
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : April 18, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Richard Goldberg, University of Maryland

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.

Condition or disease Intervention/treatment
Schizophrenia 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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Study Start Date : September 2007
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Health-related self-efficacy and recovery orientation [ Time Frame: Measured at pre- and post-intervention ]
  2. Medical illness self-management skills [ Time Frame: Measured at pre- and post-intervention ]
  3. Social and communication skills during interactions with health care providers [ Time Frame: Measured at pre- and post-intervention ]
  4. Physical and mental health status [ Time Frame: Measured at pre- and post-intervention ]
  5. Medical service use patterns [ Time Frame: Measured at pre- and post-intervention ]

Secondary Outcome Measures :
  1. Medication use [ Time Frame: Measured throughout the study ]
  2. Neurocognition [ Time Frame: Measured at baseline ]
  3. Substance abuse [ Time Frame: Measured at pre- and post-intervention ]
  4. Psychiatric symptoms [ Time Frame: Measured at pre- and post-intervention ]
  5. Amount and seriousness of related comorbidities [ Time Frame: Measured at pre- and post-intervention ]
  6. Quantitative and qualitative survey ratings [ Time Frame: Measured throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525304

United States, Maryland
Fayette Street Clinics
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
Principal Investigator: Richard W. Goldberg, PhD University of Maryland

Responsible Party: Richard Goldberg, PI, University of Maryland Identifier: NCT00525304     History of Changes
Other Study ID Numbers: HP-00040526
R34MH078168 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Keywords provided by Richard Goldberg, University of Maryland:
medical co-morbidity
heart disease
respiratory illness

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders