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Completed

NCT Number: NCT00525304

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayette Street Clinics

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management program for chronic illness

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2007
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.