Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks
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|ClinicalTrials.gov Identifier: NCT00709345|
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : April 17, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Mental Illness||Behavioral: Cognitive behavioral sessions Behavioral: Time-matched attention control sessions||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||333 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Average weight loss; body mass index; and effects across other behavioral, clinical, physiological, and ancillary measures [ Time Frame: Measured at Month 12 ]
- Ability of behavioral intervention to offset significant medical risk factors often associated with people living with mental illness [ Time Frame: Measured at Month 12 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Resides in one of the designated group homes
- 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
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
|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|
|Responsible Party:||Jeffrey Kelly, Professor of Psychiatry and Behavioral Medicine, Medical College of Wisconsin|
|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|