NCT06353100

Brief Summary

The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain (CP) and subtypes, mental and physical health, lifestyle and adversity and work characteristics. The study objectives are as follows:

  1. 1.Estimate the prevalence of CP and subtypes in the general population
  2. 2.Explore the association between mental health indicators, perceived work stress and presence of CP in the population.
  3. 3.Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP
  4. 4.Describe the use of management strategies in those who suffer from CP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

December 12, 2025

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

February 5, 2024

Last Update Submit

December 5, 2025

Conditions

Keywords

Chronic painDepressionAnxietyIncidencePrevalence

Outcome Measures

Primary Outcomes (3)

  • Chronic pain (past 3 months)

    Participants will be asked "Have you had constant or frequent pain \[most of the day\] during the past 3 months?" and asked to identify the average and maximum intensity of pain in that period using a visual analogue scale (VAS) from 0 to 10. Only participants with an average pain of 4 or more will be classified as having significant chronic pain.

    Baseline and 12-month follow-up

  • Depression (2 weeks)

    As measured by the Patient Health Questionnaire (PHQ-9). Total scores on the PHQ-9 range from 0 to 27 and higher scores indicate higher symptoms of depression.

    Baseline and 12-month follow-up

  • Anxiety (2 weeks)

    As measured by the General Anxiety Disorder (GAD-7). Total scores on the GAD-7 range from 0 to 21 and higher scores indicate higher symptoms of anxiety.

    Baseline and 12-month follow-up

Secondary Outcomes (6)

  • Migraine Disability

    12-month follow-up

  • Neuropathic Pain

    Baseline and 12-month follow-up

  • Fibromyalgia

    12-month follow-up

  • Self harm (2 weeks)

    Baseline and 12-month follow-up

  • Insomnia (2 weeks)

    Baseline and 12-month follow-up

  • +1 more secondary outcomes

Study Arms (4)

Longitudinal analysis group 1 (no pain)

Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 or march 2024

Longitudinal analysis group 2 (incident chronic pain)

Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 but reporting chronic pain in march 2024

Longitudinal analysis group 3 (remitted chronic pain)

Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 but not reporting it in march 2024

Longitudinal analysis group 4 (chronic pain at follow up)

Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 and march 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community survey in Chile

You may qualify if:

  • General population
  • Residence in urban areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, RM, 7550139, Chile

Location

MeSH Terms

Conditions

Chronic PainNeuralgiaFibromyalgiaDepressionAnxiety DisordersSelf-Injurious BehaviorSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavioral SymptomsBehaviorMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Antonia Errazuriz, PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

April 8, 2024

Study Start

January 1, 2023

Primary Completion

April 30, 2025

Study Completion

September 25, 2025

Last Updated

December 12, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

The anonymized database and codebook will be made available to researcher in the Dataverse website

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Upon first manuscript submission
Access Criteria
For researchers

Locations