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

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

Schizophrenia

Treatments

Behavioral: Self-management program for chronic illness

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00525304
R34MH078168 (U.S. NIH Grant/Contract)
HP-00040526
DAHBR 96-BHB

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

1
Experimental group
Description:
Participants will receive a self-management program for chronic illness
Treatment:
Behavioral: Self-management program for chronic illness
Usaual Care
No Intervention group
Description:
Usual Care; no additional intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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