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

NCT ID: NCT00525304

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2015-05-31

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Participants will receive a self-management program for chronic illness

Group Type: EXPERIMENTAL

Self-management program for chronic illness

Intervention Type: BEHAVIORAL

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

Usaual Care

Usual Care; no additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-management program for chronic illness

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Richard Goldberg

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard W. Goldberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Fayette Street Clinics

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R34MH078168

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 96-BHB

Identifier Type: -

Identifier Source: secondary_id

HP-00040526

Identifier Type: -

Identifier Source: org_study_id