ClinicalTrials.gov
ClinicalTrials.gov Menu

Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

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.
ClinicalTrials.gov Identifier: NCT00233142
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Syracuse University

Study Description
Go to 
Top of Page 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
Go to 
Top of Page 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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page 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 )
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