RecruitingNot ApplicableNCT06410963

ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.

ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress. A Sequential Replicated and Randomized Single Case Experimental Design (SCED).


Sponsor

Örebro University, Sweden

Enrollment

35 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Recurrent or persistent pain and psychological distress are alarmingly common problems among adolescents, in Sweden as well as globally. They often co-occur and have been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent pain and psychological distress based upon graded exposure to physical activity and reactivation.


Eligibility

Min Age: 12 YearsMax Age: 19 Years

Inclusion Criteria5

  • Age 12-19
  • Psychological distress, such as anxiety, depressive symptoms or stress, ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
  • Persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
  • Presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); > 50 on at least one activity of the PHODA.
  • Swedish speaking and able to fill out questionnaires

Exclusion Criteria5

  • Serious/malignant disease
  • Participation in other rehabilitation program
  • Severe mental health problems
  • Substance abuse
  • Severe learning disabilities

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Interventions

BEHAVIORALReactivate

The study period is 84 days (12 weeks). Depending on the length of the baseline period (randomly assigned to be 7, 14 or 21 days), the treatment period varies between 63-77 days and contains 6-11 sessions. The intervention consists of 2-4 educational sessions in pain mechanisms and fear avoidance and 4-9 sessions of individually tailored intervention with graded exposure and reactivation to avoided physical activities. Intervention will take place from one time per week to one time every two weeks, 30-60 minutes per session. Number of treatment sessions will depend on when the individual participants' goals are considered reached. If necessary, given the participants consent, their legal guardians will be invited to attend the sessions.


Locations(1)

Region Örebro county

Örebro, Sweden

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NCT06410963


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