Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients
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ClinicalTrials.gov Identifier: NCT00233142 |
Recruitment Status
:
Completed
First Posted
: October 5, 2005
Last Update Posted
: April 15, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Stress Depression | Behavioral: Expressive writing Behavioral: Neutral writing | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 187 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Expressive Writing: Complementary Treatment for Diabetes |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Expressive writing
Expressive writing
|
Behavioral: Expressive writing
Writing as therapeutic intervention
|
Sham Comparator: Neutral writing
Non-expressive writing
|
Behavioral: Neutral writing
Non-expressive writing
|
- hemoglobin A1C (indicator of blood glucose) [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
- Diabetes symptoms [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
- stress levels [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
- depression [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
- cognitive function [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
- quality of life [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]

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Ages Eligible for Study: | 25 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233142
United States, New York | |
State University of New York Medical University | |
Syracuse, New York, United States, 13244 | |
Syracuse University | |
Syracuse, New York, United States, 13244 | |
United States, Pennsylvania | |
Pennsylvania State University | |
University Park, Pennsylvania, United States, 16802 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37235 |
Principal Investigator: | Joshua M. Smyth, PhD | Syracuse University |
Responsible Party: | Syracuse University |
ClinicalTrials.gov Identifier: | NCT00233142 History of Changes |
Other Study ID Numbers: |
R01AT002477 ( U.S. NIH Grant/Contract ) |
First Posted: | October 5, 2005 Key Record Dates |
Last Update Posted: | April 15, 2016 |
Last Verified: | November 2009 |
Keywords provided by Syracuse University:
Diabetes Emotions Blood glucose Expressive Writing |
Additional relevant MeSH terms:
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |