Cognitive Behavioral Intervention in Diabetes Self-Management

Study Overview
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Brief Summary
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The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).

Official Title
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Cognitive Behavioral Intervention in Diabetes Self-Management

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Cognitive behavioral training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997) Between 18 and 76 years Participation in diabetes education program of University Specialty Clinics Exclusion Criteria: Crippling arthritis Joint replacements that limit movement Neuromuscular disease with paralysis Severe eye disease or visually impaired Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis Transplant recipient Foot Amputation Congestive Heart Failure New York Heart Class III/IV Previous Cerebral Vascular Accident (stroke) with residual paralysis Malignancy Chronic hepatitis C HIV disease Individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavioral intervention<br> | Behavioral: Cognitive behavioral training<br>* The behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program<br>|
| No Intervention: Education support<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. |  | Baseline | 
| Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. |  | Post (6 weeks) | 
| Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. |  | 6 months | 
| Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. |  | Baseline | 
| Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. |  | Post (6 weeks) | 
| Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. |  | 6 months | 
| Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Asian Pacific Islanders, Cognitive behavioral intervention