Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks
Primary Purpose
Mental Illness
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cognitive behavioral sessions
Time-matched attention control sessions
Sponsored by
About this trial
This is an interventional treatment trial for Mental Illness focused on measuring Antipsychotic Medications, Behavioral Interventions
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group Home
Control
Arm Description
Participants will receive cognitive behavioral sessions.
Participants will receive time-matched attention control sessions.
Outcomes
Primary Outcome Measures
Average weight loss; body mass index; and effects across other behavioral, clinical, physiological, and ancillary measures
Secondary Outcome Measures
Ability of behavioral intervention to offset significant medical risk factors often associated with people living with mental illness
Full Information
NCT ID
NCT00709345
First Posted
June 30, 2008
Last Updated
April 16, 2015
Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00709345
Brief Title
Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks
Official Title
Effectiveness of a Cognitive Behavioral Treatment for Reducing Atypical Antipsychotic Medication Health Risks in People With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Antipsychotic Medications, Behavioral Interventions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Home
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral sessions.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive time-matched attention control sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time-matched attention control sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average weight loss; body mass index; and effects across other behavioral, clinical, physiological, and ancillary measures
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Ability of behavioral intervention to offset significant medical risk factors often associated with people living with mental illness
Time Frame
Measured at Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Kelly, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol L. Galletly, JD, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anton M. Somlai, EdD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jill T. Owczarzak, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timothy L. McAuliffe, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David W. Seal, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas W. Heinrich, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks
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