Cognitive Behavioral Intervention in Diabetes Self-Management

Type 2 Diabetes Clinical Trial

Official title:

Cognitive Behavioral Intervention in Diabetes Self-Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182701
• Other study ID #: 5R01NR007883
• Status: Completed
• Phase: N/A
• First received: August 6, 2010
• Last updated: August 13, 2010
• Start date: August 2004
• Est. completion date: February 2010

Study information

• Verified date: August 2010
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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

Locations

Country	Name	City	State
United States	University of Hawaii School of Nursing & Dental Hygiene	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.		Baseline	No
Primary	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)	No
Primary	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	No
Primary	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	No
Secondary	Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.		Baseline	No
Secondary	Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.		Post (6 weeks)	No
Secondary	Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.		6 months	No
Secondary	Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.		1 year	No