Cognitive Behavioral Intervention in Diabetes Self-Management

August 13, 2010 updated by: University of Hawaii
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96822
        • University of Hawaii School of Nursing & Dental Hygiene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Baseline
Baseline
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)
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.
Time Frame: 6 months
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.
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Investigators

  • Principal Investigator: Jillian Inouye, PhD, APRN, Universtiy of Hawaii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 13, 2010

First Posted (ESTIMATE)

August 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 13, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01NR007883 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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