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Completed

NCT Number: NCT01182701

Cognitive Behavioral Intervention in Diabetes Self-Management

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawaii School of Nursing & Dental Hygiene

Honolulu, Hawaii, 96822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral training

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 17, 2010
Registry last updated
Aug 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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