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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT02161887

Public ClinicalTrials.gov record NCT02161887. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 4:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Healing Context in CAM: Instrument Development and Initial Validation - Phase 3 Validation Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 final, Validation 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 or neck pain who are receiving physical therapy, chiropractic care, acupuncture, medical management, 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.

Study identification

NCT ID
NCT02161887
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
University of Pittsburgh
Other
Enrollment
207 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2014
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016
Last update posted
Mar 2, 2017

2014 – 2016

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213
UPMC General Clinical Research Center Pittsburgh Pennsylvania 15213
UPMC Shadyside Center for Integrative Medicine Pittsburgh Pennsylvania 15232

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02161887, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 2, 2017 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02161887 live on ClinicalTrials.gov.

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