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

NCT00525304 | Completed

• 3 other identifiers: HP-00040526R34MH078168DAHBR 96-BHB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

medical co-morbidity; diabetes; heart disease; respiratory illness

Outcome Measures

Primary Outcomes (5)

• Health-related self-efficacy and recovery orientation

  Measured at pre- and post-intervention

• Medical illness self-management skills

  Measured at pre- and post-intervention

• Social and communication skills during interactions with health care providers

  Measured at pre- and post-intervention

• Physical and mental health status

  Measured at pre- and post-intervention

• Medical service use patterns

  Measured at pre- and post-intervention

Secondary Outcomes (6)

• Medication use

  Measured throughout the study

• Neurocognition

  Measured at baseline

• Substance abuse

  Measured at pre- and post-intervention

• Psychiatric symptoms

  Measured at pre- and post-intervention

• Amount and seriousness of related comorbidities

  Measured at pre- and post-intervention

Study Arms (2)

1

EXPERIMENTAL

Participants will receive a self-management program for chronic illness

Behavioral: Self-management program for chronic illness

Usaual Care

NO INTERVENTION

Usual Care; no additional intervention

Interventions

Self-management program for chronic illness BEHAVIORAL

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

1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Fayette Street Clinics

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Schizophrenia; Diabetes Mellitus; Heart Diseases

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Richard W. Goldberg, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)