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

Not Applicable

Recruiting

• Conditions: Chronic Pain; Emotional Distress
• Interventions: Behavioral: Reactivate

• Registration Number: NCT06410963
• Lead Sponsor: Örebro University, Sweden

Brief 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.

Detailed Description

See description of arms and intervention.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Study Start: 2024-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reactivate	Reactivate	Reactivate treatment. Daily measurements are collected throughout treatment.

Primary Outcome Measures

Name	Time	Method
Activity engagement change	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 )
Symptom distress change	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)

Secondary Outcome Measures

Name	Time	Method
Change in psychological distress	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)
Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change	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)
Functional Disability Inventory (FDI) change	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)
Center of Epidemiological Studies Depression Scales for Children (CES-DC) change	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)
The Pediatric Quality of Life Acute version (PedsQL) PedsQL™	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)
The Photograph Series of Daily Activities for youth (PHODA) change - short	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)
Pain change	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)

Trial Locations

Locations (1)

Region Örebro county; 🇸🇪 Örebro, Sweden