ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.
NCT ID: NCT06410963
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2024-06-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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No treatment waiting period
Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period.
No interventions assigned to this group
Reactivate
Reactivate treatment. Daily measurements are collected throughout treatment.
Reactivate
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.
Interventions
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Reactivate
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in other rehabilitation program
* Severe mental health problems
* Substance abuse
* Severe learning disabilities
12 Years
19 Years
ALL
No
Sponsors
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Region Örebro County
OTHER
Örebro University, Sweden
OTHER
Responsible Party
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Principal Investigators
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Katja Boersma, PhD
Role: PRINCIPAL_INVESTIGATOR
Örebro University, Sweden
Locations
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Region Örebro county
Örebro, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Reactivate
Identifier Type: -
Identifier Source: org_study_id
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