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Completed

NCT Number: NCT00233142

Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

State University of New York Medical University, Syracuse, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expressive writing

Behavioral

Writing as therapeutic intervention

Neutral writing

Behavioral

Non-expressive writing

Primary outcomes

  1. hemoglobin A1C (indicator of blood glucose)

    Time frame: baseline, 4 months, 8 months, 12 months, and 16 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Expressive Writing: Complementary Treatment for Diabetes

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 5, 2005
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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