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

NCT01266304 | Completed DMC

• 1 other identifier: AT006453 -1
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Transcribed focus group information

  Participants' opinions regarding factors that contribute to healing, such as important patient characteristics, provider characteristics, and environmental factors.

  Baseline (generally same day as study enrollment, but baseline data collection may occur at a single study visit within 4 weeks of enrollment)

Secondary Outcomes (1)

• Cognitive Interviews regarding items

  Baseline (generally same day as study enrollment, but data collection may occur at a single study visit within 4 weeks of study enrollment)

Study Arms (1)

community members

Pittsburgh area community members, including people who attend an integrative medicine clinic and people who attend a conventional medicine clinic.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample, conventional primary care clinic, and integrative medicine clinic.

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Greco CM, Glick RM, Morone NE, Schneider MJ. Addressing the "It Is Just Placebo" Pitfall in CAM: Methodology of a Project to Develop Patient-Reported Measures of Nonspecific Factors in Healing. Evid Based Complement Alternat Med. 2013;2013:613797. doi: 10.1155/2013/613797. Epub 2013 Dec 19.

  PMID: 24454501 BACKGROUND

• Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, Schneider MJ, Klem ML, McFarland CE, Lawrence S, Colditz J, Maihoefer CC, Jonas WB, Ryan ND, Pilkonis PA. Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective. Qual Life Res. 2016 Jul;25(7):1625-34. doi: 10.1007/s11136-015-1178-1. Epub 2015 Nov 12.

  PMID: 26563249 RESULT

Related Links

• PROMIS network website

Study Officials

• Carol M Greco, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 24, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 10, 2017

Record last verified: 2015-11

Locations

US (1)