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RecruitingNCT05932043WIPUpdated Jan 10, 2024

Development of the Work In Progress Questionnaire

An observational study in Low Back Pain, sponsored by International Institute of Behavioral Medicines. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by International Institute of Behavioral Medicines · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to describe the development of the Work In Progress questionnaire, a tool designed to evaluate commitment in persons, and its psychometric validation process in the context of low back pain.

Read the detailed description

The study design is cross-sectional.

The following methodology will be applied as for the development of the Work In Progress questionnaire (WIP), a tool designed to evaluate commitment in persons, and its psychometric validation:

  1. item generation and selection: the first defines the content of an index and ensures the most important topics are well-thought-out. The second eliminates redundant items, and decreases the number to a total that is feasible to administer while ensuring the scale measures the construct of interest.
  2. psychometric analysis: exploratory factor analysis (Cattel Scree Test, Varimax Rotation), reliability (internal consistency by Cronbach's alpha, test-retest reliability by Intraclass Correlation Coefficient 2.1), Measurement error (calculated by multiplying the standard error of measurement (SEM) by the z-score associated with the desired level of confidence (95%, in our case) and the square root of 2), and construct validity by hypothesis testing the correlations (Pearson r) with related measures (Pain Catastrophizing Scale, Oswestry Disability Scale, Numerical pain Rating Scale).
02

Conditions studied

  • Low Back Pain

Keywords

  • outcome measures
  • commitment
  • people
  • psychology
  • behavioural medicine
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

International Institute of Behavioral Medicines is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

People with non-specific low back pain. For full description od the condition, please see the definition provided within the references list (Chiarotto A et al).

Inclusion criteria

  • Low Back Pain
  • adult age
  • reading/speaking Italian.

Exclusion criteria

Exclusion Criteria:

  • systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases;
  • refusal to adhere.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testThis is a non-interventional study

    None (this is a non-interventional study)

06

What researchers measure

Primary outcomes

  1. WIP questionnaire

    Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment

    Time frame: At the moment of the questionnaire administration

  2. WIP questionnaire

    Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment

    Time frame: After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.

Secondary outcomes

  1. PCS

    Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing

    Time frame: At the moment of the questionnaire administration

  2. ODI

    Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability

    Time frame: At the moment of the questionnaire administration

  3. pain NRS

    Numerical pain Rating Scale; score varying from 0 to 10, with higher scores indicating greater pain intensity

    Time frame: At the moment of the questionnaire administration

07

Study locations

1 of 1 sites recruiting
  • Barbara Rocca
    Calosso, Italy
    • Barbara Rocca · Contact
    Recruiting
08

References and documents

Publications

  • Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889-95. PubMed 3955482 ↗
  • Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003 May;12(3):229-38. doi: 10.1023/a:1023254226592. PubMed 12769135 ↗
  • de Vet HCW, Terwee CB, Mokkink LB, et al. Measurement in medicine. A practical guide. Cambridge: Cambridge University Press, 2011
  • Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24. PubMed 17161752 ↗
  • Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available. PubMed 35507483 ↗
  • Hayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications; 2005 Nov 1.
  • Sullivan MJ, Bishop SR, & Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychol Assess 1995;7:524-532
  • Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available. PubMed 6450426 ↗
  • Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004. PubMed 15207508 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05932043
Lead sponsor
International Institute of Behavioral Medicines
Responsible party
Barbara Rocca (Dr, International Institute of Behavioral Medicines) — Principal investigator
First posted
Jul 6, 2023
Start date
Jul 10, 2023
Primary completion
Jul 31, 2023
Completion
Feb 29, 2024 (estimated)
Last update
Jan 10, 2024

Study contacts

Barbara Rocca, BA Psychol
Contact
info.ellis.bm@gmail.com
39.3333653393

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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