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Cognitive Behavioral Intervention in Diabetes Self-Management

Cognitive Behavioral Intervention in Diabetes Self-Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01182701
Enrollment
207
Registered
2010-08-17
Start date
2004-08-31
Completion date
2010-02-28
Last updated
2010-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, Asian Pacific Islanders, Cognitive behavioral intervention

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).

Interventions

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

Sponsors

University of Hawaii
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Secondary

MeasureTime frame
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.Baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026