This study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

Condition	Intervention	Phase
Diabetes Mellitus Stress Depression	Behavior: Expressive writing  Behavior: Neutral writing	Phase II

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcomes: Diabetes symptoms; hemoglobin A1C (indicator of blood glucose); stress levels; depression; cognitive function; quality of life
Expected Total Enrollment:  225

Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the United States. Conditions such as stress and depression have been shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. This study will determine whether diabetes patients can benefit from expressive writing. This study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms.

Participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. Participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. Some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. All participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

Ages Eligible for Study:  25 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of diabetes mellitus made after age 24

Exclusion Criteria:

• Diabetes-related emergency room visit within 3 months prior to study entry
• Use of psychiatric medication within 3 months prior to study entry
• Visual or manual limitations that preclude reading and writing
• Use of insulin within the first year of diabetes diagnosis
• Pregnancy or plan to become pregnant

Please refer to this study by ClinicalTrials.gov identifier  NCT00233142

Joshua M. Smyth, PhD      315-443-3723    jmsmyth@syr.edu

New York
      Syracuse University, Syracuse,  New York,  13244,  United States
      State University of New York Medical University, Syracuse,  New York,  13244,  United States
Pennsylvania
      Pennsylvania State University, University Park,  Pennsylvania,  16802,  United States
Tennessee
      Vanderbilt University, Nashville,  Tennessee,  37235,  United States

Study chairs or principal investigators

Joshua M. Smyth, PhD,  Principal Investigator,  Syracuse University   

Study ID Numbers:  R01 AT002477
Last Updated:  December 8, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00233142
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10