The Healing Context in CAM: Instrument Development and Initial Validation - Calibration Study

Completed

Conditions studied: Persons Receiving Any Medical or Behavioral Treatment (Focus of Study is Questionnaires)

In brief

The overall objective of this study is to develop and test an efficient set of self-report instruments 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 next step of instrument development is called Calibration, and involves 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. This current protocol in ClinicalTrials.gov pertains only to the Calibration Phase of the study. The final phase of the project will involve conducting initial validation studies of the set of instruments. The set of instruments will be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate the convergent, discriminant, and predictive validity of the HEAL instruments 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 scores should account for a significant proportion of the variance in treatment outcome, supporting predictive validity.

Key facts

Study ID

NCT01904838

Run by

University of Pittsburgh

People needed

1650

Starts

2012-09-01

Expected to finish

2014-11-01

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. age 18 or over
• 2. Males and Females
• 3. able to read, speak and understand English
• 4. able to complete informed consent procedures
• 5. able to complete questionnaires on a computer
• 6. (local sample arm:) began treatment within the past 4 weeks at the UPMC Center for Integrative Medicine or conventional medical clinics at UPMC.
• 7. (internet sample arm) self report of current or past year integrative medicine or conventional medical treatment.

You may not qualify if…

• 1. self reported History of schizophrenia or current psychotic symptoms
• 2. self reported uncontrolled current bipolar disorder
• 3. self report of substance dependence within the past 6 months
• 4. self reported history of organic neuropsychiatric syndromes (e.g., Alzheimer's, Parkinson's, dementia)
• 5. Lack of willingness or ability to provide informed consent

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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