ClinicalTrials.gg
CompletedNCT00740233PROCAIMUpdated Mar 27, 2014

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

An observational study in Gastrointestinal Diseases, Chronic Pain and Stress, sponsored by University of California, Los Angeles. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-27.

Sponsored by University of California, Los Angeles · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,300
Ages
18 Years to 65 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • 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
03

In context

Gastrointestinal Diseases

639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.

This study's enrollment of 2,300 is above the median of 350 across 195 observational studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,300 participants (actual)
06

What researchers measure

Primary outcomes

  1. Perceived Stress, Mindfulness, Somatization

    Online surveys at intervals over 1 year.

    Time frame: 1,3,6,9,12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00740233
First posted
Aug 22, 2008
Start date
Jun 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Mar 27, 2014

Study contacts

Deborah Ackerman, Ph.D.
principal investigator · UCLA School of Public Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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