Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus; Stress; Depression	Behavioral: Expressive writing; Behavioral: Neutral writing	Phase 2

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. hemoglobin A1C (indicator of blood glucose) [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]

Secondary Outcome Measures :

1. Diabetes symptoms [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
2. stress levels [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
3. depression [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
4. cognitive function [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]
5. quality of life [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	25 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Syracuse University

National Center for Complementary and Integrative Health (NCCIH)

Investigators

Principal Investigator:	Joshua M. Smyth, PhD	Syracuse University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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