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The Healing Context in Complementary and Alternative Medicine (CAM): Instrument Development and Initial Validation

NCT01266304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2017-02-10

No results posted yet for this study

Summary

The overall objective of this study is to develop and test an efficient self-report instrument to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors important in healing.

The initial phase of the study involves developing and refining an item bank. During the initial 'item bank development' phase, the investigators will run focus groups and cognitive interviews with individuals who participate in CAM and conventional medicine interventions.

The current protocol in ClinicalTrials.gov pertains only to the initial phase of the study involving focus groups and cognitive interviews.

The next step of instrument development is called Calibration, and will involve administering the revised item bank to an internet sample and to persons who receive services in a CAM clinic and a conventional primary care setting. The items will be calibrated using item response theory and classical test theory. This will result in a computerized adaptive testing version of the instrument, as well as a static short form of the instrument.

The final phase of the project will involve conducting initial validation studies of the instrument. The instrument will be called the Healing Encounters and Attitudes List (HEAL). The investigators will evaluate the convergent, discriminant, and predictive validity of the HEAL in a sample of 200 persons with chronic low back pain who are receiving physical therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display moderate to large correlations with measures of similar constructs. The HEAL is expected to correlate modestly with self-report measures of general psychosocial functioning, in support of discriminant validity. Finally, HEAL score should account for a significant proportion of the variance in treatment outcome, supporting predictive validity.

Conditions

  • Any Condition

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Carol M Greco, Ph.D. · University of Pittsburgh

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266304 on ClinicalTrials.gov