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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00525304
First received: September 4, 2007
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

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 Intervention
Schizophrenia
Behavioral: Self-management program for chronic illness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Health-related self-efficacy and recovery orientation [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Medical illness self-management skills [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Social and communication skills during interactions with health care providers [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Physical and mental health status [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Medical service use patterns [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication use [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Neurocognition [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Substance abuse [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Psychiatric symptoms [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Amount and seriousness of related comorbidities [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ]
  • Quantitative and qualitative survey ratings [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525304

Contacts
Contact: Richard W. Goldberg, PhD 410-706-8473 rgoldber@psych.umaryland.edu
Contact: Wendy L. Potts, MS 410-706-6638 wpotts@psych.umaryland.edu

Locations
United States, Maryland
Fayette Street Clinics Recruiting
Baltimore, Maryland, United States, 21201
Contact: Richard W. Goldberg, PhD    410-706-8473    rgoldber@psych.umaryland.edu   
Contact: Wendy Potts    410-706-2490    wpotts@psych.umaryland.edu   
Principal Investigator: Richard W. Goldberg, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Richard W. Goldberg, PhD University of Maryland
  More Information

No publications provided

Responsible Party: William T. Riely, Program Official, NIMH
ClinicalTrials.gov Identifier: NCT00525304     History of Changes
Other Study ID Numbers: R34 MH078168, DAHBR 96-BHB
Study First Received: September 4, 2007
Last Updated: March 30, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
medical co-morbidity
diabetes
heart disease
respiratory illness

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014