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

May 8, 2024 updated by: Örebro University, Sweden

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

See description of arms and intervention.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Örebro, Sweden, 70217
        • Recruiting
        • Region Örebro county
        • Contact:
        • Principal Investigator:
          • Emma Nilsing-Strid, PhD
        • Sub-Investigator:
          • Anna Duberg, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment waiting period
Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period.
Experimental: Reactivate
Reactivate treatment. Daily measurements are collected throughout treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity engagement change
Time Frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention
Change in self-rated activity engagement. Numerical Rating Scale, range 0-6 (1 question: lower values, worse outcome, 1 question: Lower values, better outcome )
repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention
Symptom distress change
Time Frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention.
Change in self-rated distress about symptoms. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)
repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Disability Inventory (FDI) change
Time Frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in functional disability. Descriptive Rating Scale, range 0-64 (higher values, worse outcome)
baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Center of Epidemiological Studies Depression Scales for Children (CES-DC) change
Time Frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in depressive symptoms. Descriptive Rating Scale, range 0-60 (higher values, worse outcome)
baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
The Pediatric Quality of Life Acute version (PedsQL) PedsQL™
Time Frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in quality of life. Descriptive Rating Scale, range 0-92 (higher values, worse outcome)
baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in psychological distress
Time Frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Change in self-related symptoms of psychological distress. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)
repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Pain change
Time Frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Change in self-related pain symptoms. Numerical Rating Scale range 0-6 (higher values, worse outcome)
repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change
Time Frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in fear of pain. Descriptiv Rating Scale, range 0-40 (higher values worse outcome)
baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
The Photograph Series of Daily Activities for youth (PHODA) change - short
Time Frame: First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)
Change in percieved harmfulness. Photographs with 50 activities, rated on a Subjective Self-rating Scale, range 0-100mm/item (higher values, worse outcome)
First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), medical resources
Time Frame: baseline, 12 weeks, 6 months after terminated intervention
Change in use of medical resources. Dichotomous scale completed by open ended answers if answer is yes.
baseline, 12 weeks, 6 months after terminated intervention
Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), school absence
Time Frame: baseline, 12 weeks, 6 months after terminated intervention
Change in school abcense. Dichotomous scale completed by open ended answers if answer is yes. One question is completed by one question with Numerical Rating Scale 1-10 (higher values, worse outcome) if answer is yes.
baseline, 12 weeks, 6 months after terminated intervention
Accelerometer
Time Frame: 7 days of the first week of baseline (randomly assigned to be 7, 14 or 21 days). 7 days assessment 6 months after terminated assessment.
Change in physical activity, digital device counting steps
7 days of the first week of baseline (randomly assigned to be 7, 14 or 21 days). 7 days assessment 6 months after terminated assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Katja Boersma, PhD, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reactivate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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