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

NCT ID: NCT06410963

Last Updated: 2024-05-13

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Emotional Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This study employs a sequential single-case experimental AB design with randomized waiting period lengths (7, 14 or 21 days). Included in the design is also standardized pre-post and 6-month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from participating adolescents.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Reactivate

Reactivate treatment. Daily measurements are collected throughout treatment.

Group Type EXPERIMENTAL

Reactivate

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Tove Axelsson-Landberg, MSc

Role: CONTACT

+46 736318264

Emma Nilsing-Strid, PhD

Role: CONTACT

+46 721411696

Facility Contacts

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Tove Axelsson-Landberg, McS

Role: primary

+46 721410514

Other Identifiers

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Reactivate

Identifier Type: -

Identifier Source: org_study_id

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