Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00233142

First Posted: October 5, 2005

Last Update Posted: April 15, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

Syracuse University

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Expressive Writing: Complementary Treatment for Diabetes

Further study details as provided by Syracuse University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	187
Study Start Date:	September 2005
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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


Responsible Party:	Syracuse University
ClinicalTrials.gov Identifier:	NCT00233142 History of Changes
Other Study ID Numbers:	R01AT002477 ( U.S. NIH Grant/Contract )
First Submitted:	September 13, 2005
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

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