Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine

Depression Clinical Trial

— PROCAIM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740233
• Other study ID #: PROCAIM2008
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: March 26, 2014
• Start date: June 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2009
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The investigators are inviting people with fibromyalgia, IBS, interstitial cystitis, chronic pain, and other chronic and recurring conditions to sign up and participate in a year-long Internet-based survey to study the effectiveness of alternative medicine and the interactions among stress and coping, pain, and treatment outcomes.

The survey is called PROCAIM, which stands for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine. PROCAIM was developed under a grant to UCLA researchers from the National Center for Complementary and Alternative Medicine.

This is a web-based study composed of surveys that will recur at intervals over 1 year!

TO ENROLL

• Log in to our web site: http://www.procaim.org/

• Register as a New User.

• Select clinic name: ClinicalTrials.gov.

• Read and sign the Consent Form.

After participants"sign" the form with their email address, participants can begin to answer the first in a series of questionnaires. The system will send participants email reminders at the time of each scheduled follow-up for one year.

For further information about PROCAIM, please contact:

• Deborah Ackerman, Ph.D.

• Department of Epidemiology

• UCLA School of Public Health

• Box 951772

• Los Angeles, CA 90095-1772

• deborah.ackerman@ucla.edu

Description:

PROCAIM, which stands for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine, was developed to collect and manage longitudinal patient data and implement patient-based outcomes assessment protocols at clinical sites around the country that offer various forms of CAM as well as clinics that provide the combination of conventional medicine with complementary and alternative therapies. PROCAIM is currently being used for a 12 month longitudinal survey to evaluate interactions among stress, symptoms, severity, and general well-being among people with fibromyalgia, IBS, chronic fatigue, and other chronic pain conditions, and the frequency and impact of co-morbid conditions among users of complementary and alternative medicines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Everyone who has a computer and is fluent in English will be eligible.

Exclusion Criteria:

• Only people with access to personal computers and the Internet and fluency in English will be able to participate. These exclusions are not based on age, gender, pregnancy, racial, or ethnic origin.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain
• Depression
• Digestive System Diseases
• Gastrointestinal Diseases
• Stress

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Center for Complementary and Integrative Health (NCCIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress, Mindfulness, Somatization	Online surveys at intervals over 1 year.	1,3,6,9,12 months	No