We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00709345
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeffrey Kelly, Medical College of Wisconsin

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will evaluate the effectiveness of a cognitive behavioral treatment in reducing significant medical risk factors often associated with people who have a serious mental illness and are taking atypical antipsychotic medications.

Condition or disease Intervention/treatment Phase
Mental Illness Behavioral: Cognitive behavioral sessions Behavioral: Time-matched attention control sessions Phase 1 Phase 2

Detailed Description:

Serious mental illness encompasses a large range of symptoms varying in severity, but generally includes symptoms described as both positive and negative. Positive symptoms include confused thinking, delusions, and hallucinations, while negative symptoms include lack of emotion and depression. Because novel or atypical antipsychotic medications target both positive and negative symptoms and have fewer side effects than other medications, they make up the current standard of care for the treatment of many mental illnesses. However, there is growing concern that the psychiatric benefits associated with atypical antipsychotic medications are offset by serious negative medical consequences, including weight gain, obesity-related cardiovascular risk, insulin resistance, and diabetes. Behavioral interventions that aim to help people coping with serious mental illness to reduce weight, sustain weight loss, and achieve better fitness may improve the risk/benefit ratio of atypical antipsychotic medications. A small-group cognitive behavioral intervention that provides peer and structural risk-reduction support may be the most beneficial means of promoting healthy eating and exercise habits in people with serious mental illness who are living in group homes. This study will evaluate the effectiveness of a small-group cognitive behavioral intervention conducted in group homes for reducing significant medical risk factors often associated with people who have a serious mental illness and are taking atypical antipsychotic medications.

Participation in this study will last about 18 months through follow-up. All participants will undergo baseline assessments that will include the following: measurements of diet and exercise patterns, using self-report and observational methods; measurements of weight, body mass index, body fat distribution, pulse rate, and blood pressure; blood draws; and questions about psychological well-being and quality of life. Group homes will then be assigned randomly to provide participating residents with either the cognitive behavioral intervention or the time-matched attention control program. Participants in both groups will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. The cognitive behavioral sessions will focus on promoting healthy behaviors, dieting, and exercise. The time-matched attention control sessions will focus on improving communications, developing healthy techniques for coping with stress, and resolving conflicts. After completing treatment, all participants will receive 6 monthly 1-hour booster sessions of their assigned treatments. They will also repeat the baseline assessments 3 times over the following 12 months.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Cognitive Behavioral Treatment for Reducing Atypical Antipsychotic Medication Health Risks in People With Serious Mental Illness
Study Start Date : July 2006
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group Home
Participants will receive cognitive behavioral sessions.
 Behavioral: Cognitive behavioral sessions
Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on promoting healthy behaviors, dieting, and exercise.
Active Comparator: Control
Participants will receive time-matched attention control sessions.
 Behavioral: Time-matched attention control sessions
Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on improving communications, developing healthy techniques for coping with stress, and resolving conflicts.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Average weight loss; body mass index; and effects across other behavioral, clinical, physiological, and ancillary measures [ Time Frame: Measured at Month 12 ]

Secondary Outcome Measures :
  1. Ability of behavioral intervention to offset significant medical risk factors often associated with people living with mental illness [ Time Frame: Measured at Month 12 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resides in one of the designated group homes

Exclusion Criteria:

  • Sufficiently impaired because of a psychiatric illness, as reflected in mental status in which informed judgment about study participation cannot be assured at the time of study entry
  • Medical contraindication to study participation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709345


Sponsors and Collaborators
Medical College of Wisconsin
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
Study Director: Carol L. Galletly, JD, PhD Medical College of Wisconsin
Study Director: Anton M. Somlai, EdD Medical College of Wisconsin
Study Director: Jill T. Owczarzak, PhD Medical College of Wisconsin
Study Director: Timothy L. McAuliffe, PhD Medical College of Wisconsin
Study Director: David W. Seal, PhD Medical College of Wisconsin
Study Director: Thomas W. Heinrich, MD Medical College of Wisconsin
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jeffrey Kelly, Professor of Psychiatry and Behavioral Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00709345    
Other Study ID Numbers: R01MH078576 ( U.S. NIH Grant/Contract )
R01MH078576 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015
Keywords provided by Jeffrey Kelly, Medical College of Wisconsin:
Antipsychotic Medications
Behavioral Interventions
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders