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Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.
To determine whether the changes in BMI produced in subjects with Bipolar Disorder (BD) and Schizoaffective Disorder (SA) by 12 months of treatment with clozapine, can be diminished after an intense and highly structured intervention focused on diet and exercise, compared with the usual brief counseling regarding weight gain on this drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counselling as Usual | Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes |
| |
| Cognitive Behavoural Therapy | Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counselling as Usual | Behavioral | 5 - 20 minutes, about the effects of clozapine on body weight, appetite, blood sugar and fats such as cholesterol and triglycerides in the blood, and how these might affect your health in the future. |
| Measure | Description | Time Frame |
|---|---|---|
| Increases in BMI in subjects with BD and SA after 12 months of clozapine treatment will be smaller in subjects treated with CBT ex/diet compared with those receiving CAU. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse changes in plasma lipids, blood sugar, and fitness level will be greater in subjects treated with CBT ex/diet compared with those receiving CAU after 12 months of clozapine treatment. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Psychiatric outpatients from within the catchment area of the hospitalwho suffer from chizoaffective disorder and respond poorly to treatment offered to participate in research
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hasey, MD | St. Joseph's Healthcare and McMaster University, Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare, Centre for Mountain Health Services | Hamilton | Ontario | L8N 3K7 | Canada |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| CBT | Behavioral | 45 - 60 minutes individual treatment sessions focused on nutrition, exercise and weight control and will occur weekly for 4 weeks. After this, 10 group sessions focused on weight reduction will be held every 2 weeks. This will be followed by 6 group sessions focused on weight maintenance held every 2 weeks. |
|
| D001519 | Behavior |
| D005159 | Health Care Facilities Workforce and Services |