Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Syracuse University
ClinicalTrials.gov Identifier:
NCT00233142
First received: September 13, 2005
Last updated: November 24, 2009
Last verified: November 2009

September 13, 2005
November 24, 2009
September 2005
February 2009   (final data collection date for primary outcome measure)
hemoglobin A1C (indicator of blood glucose) [ Time Frame: baseline, 4 months, 8 months, 12 months, and 16 months ] [ Designated as safety issue: No ]
  • hemoglobin A1C (indicator of blood glucose)
  • Diabetes symptoms
  • stress levels
  • depression
  • cognitive function
  • quality of life
Complete list of historical versions of study NCT00233142 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients
Expressive Writing: Complementary Treatment for Diabetes

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Stress
  • Depression
  • Behavioral: Expressive writing
    Writing as therapeutic intervention
  • Behavioral: Neutral writing
    Non-expressive writing
  • Experimental: Expressive writing
    Expressive writing
    Intervention: Behavioral: Expressive writing
  • Sham Comparator: Neutral writing
    Non-expressive writing
    Intervention: Behavioral: Neutral writing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00233142
R01 AT002477, R01AT002477
Yes
Tracy Cromp/Director Office of Research Integrity and Protections, SyracuseU
Syracuse University
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Joshua M. Smyth, PhD Syracuse University
Syracuse University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP