Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00233142

Purpose

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	Behavioral: Expressive writing Behavioral: Neutral writing	Phase II

MedlinePlus related topics: Depression Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Expressive Writing: Complementary Treatment for Diabetes

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

Primary Outcome Measures:

Diabetes symptoms
hemoglobin A1C (indicator of blood glucose)
stress levels
depression
cognitive function
quality of life

Estimated Enrollment:	225
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Expressive writing: Experimental Expressive writing	Behavioral: Expressive writing Writing as therapeutic intervention
Neutral writing: Sham Comparator Non-expressive writing	Behavioral: Neutral writing Non-expressive writing

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233142

Contacts

Contact: Joshua M. Smyth, PhD

315-443-3723

jmsmyth@syr.edu

Locations

United States, New York
Syracuse University	Recruiting
Syracuse, New York, United States, 13244
Contact: Kristin Heron, BA 315-443-2950 keheron@syr.edu
Principal Investigator: Joshua M. Smyth, PhD
Sub-Investigator: Martin Sliwinski, PhD
State University of New York Medical University	Recruiting
Syracuse, New York, United States, 13244
Contact: Kristin Heron, BA 315-443-2950 keheron@syr.edu
Principal Investigator: Paula Trief, PhD
Sub-Investigator: Ruth Weinstock, MD
Sub-Investigator: Roger Greenberg, PhD
United States, Pennsylvania
Pennsylvania State University	Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Josy Lyons Mauger, RN 814-865-1392 jlm38@psu.edu
Principal Investigator: Jan Ulbrecht, MD
Sub-Investigator: Cheryl Dellasega, CRNP, PhD
United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37235
Contact: Kathleen Wolff, MSN 615-936-1314
Contact: Marlon Fielder, BS 615 936 1314 marlon.t.fielder@vanderbilt.edu
Principal Investigator: Kenneth Wallston, PhD
Sub-Investigator: Joseph Hepworth, PhD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Joshua M. Smyth, PhD

Syracuse University

More Information

Study ID Numbers:	R01 AT002477
Study First Received:	September 13, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00233142
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Diabetes
Emotions
Blood glucose
Expressive Writing

Study placed in the following topic categories:

Metabolic Diseases
Depression
Diabetes Mellitus
Endocrine System Diseases
Stress

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009