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Cognitive Behavioral Intervention in Diabetes Self-Management

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ClinicalTrials.gov Identifier: NCT01182701
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: Cognitive behavioral training

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cognitive Behavioral Intervention in Diabetes Self-Management
Study Start Date : August 2004
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Behavioral intervention Behavioral: Cognitive behavioral training
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
No Intervention: Education support


Outcome Measures

Primary Outcome Measures :
  1. Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. [ Time Frame: Baseline ]
  2. Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. [ Time Frame: Post (6 weeks) ]
  3. Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. [ Time Frame: 6 months ]
  4. Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: Baseline ]
  2. Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: Post (6 weeks) ]
  3. Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: 6 months ]
  4. Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT01182701


Locations
United States, Hawaii
University of Hawaii School of Nursing & Dental Hygiene
Honolulu, Hawaii, United States, 96822
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Jillian Inouye, PhD, APRN Universtiy of Hawaii
More Information

Responsible Party: Jillian Inouye/Principal Investigator, University of Hawaii
ClinicalTrials.gov Identifier: NCT01182701     History of Changes
Other Study ID Numbers: 5R01NR007883 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: August 2010

Keywords provided by University of Hawaii:
Type 2 Diabetes
Asian Pacific Islanders
Cognitive behavioral intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases