Clinical trial NCT00740233: Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Chronic Pain
Stress
Anxiety
Depression
Keywords: fibromyalgia
irritable bowel syndrome
interstitial cystitis
chronic fatigue syndrome
vulvodynia
chronic stress
chronic pain
stress-related conditions
functional GI disorders
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-08-22
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In general, participants will be: at least 18 years of age; ambulatory (i.e., not depending upon a wheelchair for mobility); and meet general criteria for psychosomatic or functional disorders including irritable bowel syndrome, other functional disorders, fibromyalgia, chronic pain, or related mood and anxiety disorders.

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress, Mindfulness, Somatization
timeFrame: 1,3,6,9,12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCLA School of Public Health
name: Deborah Ackerman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: