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Completed No phase listed Observational Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT01266304

Public ClinicalTrials.gov record NCT01266304. 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 19, 2026, 9:37 PM 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

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 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.

Study identification

NCT ID
NCT01266304
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
University of Pittsburgh
Other
Enrollment
72 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

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

Study timeline

Start date
Dec 31, 2010
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015
Last update posted
Feb 9, 2017

2011 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213

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 NCT01266304, 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 Feb 9, 2017 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01266304 live on ClinicalTrials.gov.

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