Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

This study has been completed.

Sponsor:

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

Information provided by:

Syracuse University

ClinicalTrials.gov Identifier:

NCT00233142

First received: September 13, 2005

Last updated: November 24, 2009

Last verified: November 2009

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Expressive Writing: Complementary Treatment for Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diabetes symptoms [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ] [ Designated as safety issue: No ]
stress levels [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ] [ Designated as safety issue: No ]
depression [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ] [ Designated as safety issue: No ]
cognitive function [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ] [ Designated as safety issue: No ]
quality of life [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	225
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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


Responsible Party:	Tracy Cromp/Director Office of Research Integrity and Protections, SyracuseU
ClinicalTrials.gov Identifier:	NCT00233142 History of Changes
Other Study ID Numbers:	R01 AT002477, R01AT002477
Study First Received:	September 13, 2005
Last Updated:	November 24, 2009
Health Authority:	United States: Federal Government

Keywords provided by Syracuse University:


Diabetes Emotions Blood glucose Expressive Writing

ClinicalTrials.gov processed this record on March 03, 2015

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