Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Depression Clinical Trial

Official title:

Expressive Writing: Complementary Treatment for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233142
• Other study ID #: R01AT002477
• Secondary ID: R01AT002477
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 13, 2016
• Start date: September 2005
• Est. completion date: February 2009

Study information

• Verified date: November 2009
• Source: Syracuse University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Diabetes Mellitus
• Stress

Intervention

Behavioral:
• Expressive writing
Writing as therapeutic intervention
• Neutral writing
Non-expressive writing

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee
United States	State University of New York Medical University	Syracuse	New York
United States	Syracuse University	Syracuse	New York
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1C (indicator of blood glucose)		baseline, 4 months, 8 months, 12 months, and 16 months	No
Secondary	Diabetes symptoms		baseline, 4 months, 8 months, 12 months, and 16 months	No
Secondary	stress levels		baseline, 4 months, 8 months, 12 months, and 16 months	No
Secondary	depression		baseline, 4 months, 8 months, 12 months, and 16 months	No
Secondary	cognitive function		baseline, 4 months, 8 months, 12 months, and 16 months	No
Secondary	quality of life		baseline, 4 months, 8 months, 12 months, and 16 months	No