Clinical trial NCT06410963: ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.
Official title: ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress. A Sequential Replicated and Randomized Single Case Experimental Design (SCED).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Emotional Distress
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Region Örebro County
First posted: 2024-05-13
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Activity engagement change
timeFrame: 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
measure: Symptom distress change
timeFrame: 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 outcomes:
measure: Functional Disability Inventory (FDI) change
timeFrame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
measure: Center of Epidemiological Studies Depression Scales for Children (CES-DC) change
timeFrame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
measure: The Pediatric Quality of Life Acute version (PedsQL) PedsQL™
timeFrame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
measure: Change in psychological distress
timeFrame: 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.
measure: Pain change
timeFrame: 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.
measure: Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change
timeFrame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
measure: The Photograph Series of Daily Activities for youth (PHODA) change - short
timeFrame: First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)
Other outcomes:
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), medical resources
timeFrame: baseline, 12 weeks, 6 months after terminated intervention
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), school absence
timeFrame: baseline, 12 weeks, 6 months after terminated intervention
measure: Accelerometer
timeFrame: 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.
Locations:
city: Örebro
country: Sweden
facility: Region Örebro county
Study officials:
affiliation: Örebro University, Sweden
name: Katja Boersma, PhD
role: PRINCIPAL_INVESTIGATOR
References: