Clinical trial NCT00233142: Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients
Official title: Expressive Writing: Complementary Treatment for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Stress
Depression
Keywords: Diabetes
Emotions
Blood glucose
Expressive Writing
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-10-05
Enrollment: 187
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: hemoglobin A1C (indicator of blood glucose)
timeFrame: baseline, 4 months, 8 months, 12 months, and 16 months
Secondary outcomes:
measure: Diabetes symptoms
timeFrame: baseline, 4 months, 8 months, 12 months, and 16 months
measure: stress levels
timeFrame: baseline, 4 months, 8 months, 12 months, and 16 months
measure: depression
timeFrame: baseline, 4 months, 8 months, 12 months, and 16 months
measure: cognitive function
timeFrame: baseline, 4 months, 8 months, 12 months, and 16 months
measure: quality of life
timeFrame: baseline, 4 months, 8 months, 12 months, and 16 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: State University of New York Medical University
state: New York
city: Syracuse
country: United States
facility: Syracuse University
state: New York
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Syracuse University
name: Joshua M. Smyth, PhD
role: PRINCIPAL_INVESTIGATOR
References: