Text Size

Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
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:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233142

Locations
United States, New York
Syracuse University
Syracuse, New York, United States, 13244
State University of New York Medical 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 Alternative Medicine (NCCAM)
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013