Clinical trial NCT06981312: Internet-Delivered Psychological Treatments for Chronic Pain in Adolescents: ACT and Pain Education.
Official title: Internet-Delivered Acceptance and Commitment Therapy for Chronic Pain in Adolescents: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Nociplastic Pain
Pain Management
Acceptance and Commitment Therapy
Cognitive Behavior Therapy
Keywords: Pain Science Education
Pain Education
Chronic Pain
Nociplastic Pain
Pain Management
Acceptance and Commitment Therapy
Cognitive Behavior Therapy
Adolescent
Parent-Child Relations
Psychological Flexibility
iCBT
Telemedicine
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: Forskningsrådet för hälsa, arbetsliv och välfärd (FORTE)
First posted: 2025-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One in four children in Sweden experiences chronic pain. For many, the pain is temporary, but for about 5% it significantly affects daily life, leading to sleep problems, school absence, and reduced physical activity. Youth with chronic pain report lower life satisfaction and overall health compared to their peers. In most cases, there is no underlying disease or injury, suggesting that chronic pain is a condition in itself, driven by dysregulation in the pain system and influenced by biological, psychological, and social factors.

National guidelines in Sweden recommend cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) for children and adolescents with chronic pain and substantial functional limitations. However, more high-quality randomized controlled trials (RCTs) are needed to strengthen the evidence base for these treatments.

The investigators' clinic has developed and evaluated ACT-based treatments for pediatric chronic pain over the past two decades. The protocol has now been adapted into an internet-delivered version to increase accessibility. In a preliminary feasibility study, the investigators observed promising effects on pain interference, though some usability issues have since been addressed.

The treatment is grounded in the fear-avoidance model, which explains how avoidance of pain-related activities can worsen disability over time. In ACT, such avoidance is seen as driven by unwanted thoughts, emotions, and bodily sensations. The aim of treatment is to help young people relate more flexibly to pain and fear and to move toward personally meaningful goals - a skill referred to as psychological flexibility. Exposure is a core component of ACT, encouraging patients to engage with avoided thoughts, feelings, and activities in order to reduce avoidance and improve functioning.

In addition to treating the young person, the study also targets parental behaviors. Parents often respond to their child's pain by increasing protection and monitoring, which is natural but can sometimes contribute to further avoidance and reduced independence in the child. ACT-based parent support is designed to help caregivers support their child more effectively.

In this randomized trial, internet-delivered ACT will be compared to two control conditions: (1) an active comparator involving online pain education, and (2) a passive control group on a wait list. The pain education intervention is based on Pain Science Education (PSE), which aims to shift how individuals understand their pain - from seeing it as a sign of injury to recognizing it as a false alarm in the nervous system. PSE has shown promising effects in adults, but research in youth is still limited, and no RCTs have yet been published.

The study responds to the need for well-designed digital interventions that reach more young people, evaluate treatment components more clearly, and include comparison groups that also receive digital interventions. The goal of the study is to further improve treatment effects by (1) emphasizing exposure strategies to reduce avoidance, (2) expanding pain education to enhance treatment understanding, and (3) refining parent support to better help families manage chronic pain over the long term.

The project aims to increase knowledge about the effects of psychological treatments - in this case delivered online - for adolescents with chronic pain. As previous studies have highlighted the promise of exposure-based strategies and digital accessibility, the study aims to evaluate the effect of a treatment that combines and optimizes both. The study also aims to better understand the specific impact of pain education as a stand-alone intervention, as this is a growing research field with limited studies in youth. Regarding the parent support component of ACT, the study will evaluate whether changes in parental behaviors related to their child's pain are associated with reduced parenting stress and improved functioning and quality of life in the adolescents. In addition to evaluating treatment outcomes, the study aims to explore the underlying processes that may contribute to the effects of ACT and pain education.


Eligibility criteria: Inclusion Criteria:

* Adolescents aged 13-19 years with chronic pain (duration ≥ 3 months).
* Have undergone a medical examination regarding their pain condition.
* Are not using pain-relieving medication, or have been stable on such medication for at least 2 months, with no planned medication changes.
* Have not undergone ACT or CBT treatment in the past six months.
* Can read and write in Swedish without difficulty.
* Have access to a smartphone/computer with an internet connection and e-ID.
* Have at least one parent or guardian who is willing and able to participate in parallel parent support treatment.

Exclusion Criteria:

* Insufficient understanding of Swedish to complete study-related tasks.
* Adolescents currently undergoing ACT or CBT treatment.
* Adolescents who are using pain-relieving medication or have unstable medication regimes.
* Adolescents without access to a smartphone/computer or e-ID.

Primary outcomes:
measure: Pain Interference Index
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
Secondary outcomes:
measure: Psychological Inflexibility in Pain Scale-Avoidance (PIPS-A)
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: KIDSCREEN-10
timeFrame: Collected at baseline and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: Revised-Childrens Anxiety and Depression Scale 25 (RCADS-25)
timeFrame: Collected at baseline and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: Fear of Pain Questionnaire - Child - Short Form (FOPQ-C-SF)
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: Numeric Rating Scale (NRS) - Pain Intensity
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: Numeric Rating Scale (NRS) - Pain Interference
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: Pain Reactivity Scale for Parents (PRS-P)
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: School Absence (Parent-Reported)
timeFrame: Collected at baseline and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: The Parent Psychological Flexibility Questionnaire (PPFQ-10)
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
measure: Adult Responses to Children's Symptoms - Protect and Monitor - Youth (ARCS)
timeFrame: Collected at baseline, periprocedural, and directly after completion of the treatment/control condition, as well as at follow-up 3 weeks, 6 months, and 12 months after the end of active treatment.
Other outcomes:
Locations:
city: Vallentuna
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: