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

Completed

Conditions studied: Any Condition

In brief

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.

Key facts

Study ID

NCT01266304

Run by

University of Pittsburgh

People needed

72

Starts

2011-01-01

Expected to finish

2015-08-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 18 or over
• Males and Females
• able to read, speak and understand English
• able to complete informed consent procedures

You may not qualify if…

• self reported History of schizophrenia or current psychotic symptoms
• self reported History of bipolar disorder
• self report of substance dependence within the past 6 months
• self reported history of organic neuropsychiatric syndromes (e.g., Alzheimer's, Parkinson's, dementia)
• Lack of willingness or ability to provide informed consent
• Subjects may only complete either 1.) focus group or 2.) cognitive interview

Where it is running

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

Full record on ClinicalTrials.gov

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