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Internet-based Cognitive Behavioral Therapy and Physiotherapy in Persons With Chronic Widespread Pain

NCT04624139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2024-05-16

No results posted yet for this study

Summary

Objectives: To investigate the effect on pain of a stress reducing treatment that combine Internet based cognitive behavioral therapy (I-CBT) and physiotherapy in persons with chronic widespread pain (CWP) and to examine factors predicting potential improvement.

Methods: 200 persons with CWP will be recruited from different parts of Region Västra Götaland (VGR) in Sweden, and randomized into two groups.

Group 1: Combined intervention of stress reducing I-CBT and Physiotherapy. Group 2: Physiotherapy only.

The participants complete a battery of questionnaires of symptoms and health related aspects at baseline, 6, 12 and 24 months. Interventions will take place at local rehabilitation centers in VGR.

Conditions

  • Pain, Chronic
  • Widespread Chronic Pain

Interventions

BEHAVIORAL

Internet-based cognitive behavioral therapy + physiotherapy

Combined intervention of stress reducing I-CBT and physiotherapy. The intervention consists of two components; I-CBT and physiotherapy aiming to reduce symptoms of stress. I-CBT: Designed to reduce stress, during 8 weeks. Physiotherapy: A total of three visits with a physiotherapist (at start, after 4 weeks and after 12 weeks). Visit 1 (at start): The participant and the physiotherapist design together an individual plan of physical activity, based on the recommendations for stress as suggested in the Physical Activity in the Prevention and Treatment of Disease (FYSS in Swedish): Physical activity on moderate intensity 150 min/week and a strengthening exercise program performed at twice a week. The physical activity is performed outside health care - in the participant´s home or in other exercise premises outside health care Visit 2 and 3 (after 4 and 12 weeks): Follow up and revision of the Physical activity plan.

BEHAVIORAL

Physiotherapy only

A total of three visits with a physiotherapist (at start, after 4 weeks and after 12 weeks). Visit 1 (at start): The participant and the physiotherapist design together an individual plan of physical activity, based on the recommendations for stress as suggested in the Physical Activity in the Prevention and Treatment of Disease (FYSS in Swedish): Physical activity on moderate intensity 150 min/week and a strengthening exercise program performed at twice a week. The physical activity is performed outside health care - in the participant´s home or in other exercise premises outside health care Visit 2 and 3 (after 4 and 12 weeks): Follow up and revision of the Physical activity plan.

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Anna Bergenheim, PhD · Vastra Gotaland Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624139 on ClinicalTrials.gov