Actively Recruiting

Phase Not Applicable
Age: 13Years - 19Years
All Genders
NCT06981312

Internet-Delivered Psychological Treatments for Chronic Pain in Adolescents: ACT and Pain Education.

Led by Region Stockholm · Updated on 2025-05-20

150

Participants Needed

1

Research Sites

134 weeks

Total Duration

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Sponsors

R

Region Stockholm

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Internet-Delivered Psychological Treatments for Chronic Pain in Adolescents: ACT and Pain Education.

Who Can Participate

Age: 13Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents aged 13-19 years with chronic pain lasting 3 months or more
  • Have had a medical examination regarding their pain condition
  • Not using pain-relieving medication or stable on such medication for at least 2 months with no planned changes
  • No prior Acceptance and Commitment Therapy or Cognitive Behavioral Therapy treatment in the past 6 months
  • Ability to read and write Swedish without difficulty
  • Access to a smartphone or computer with internet connection and e-ID
  • At least one parent or guardian willing and able to participate in parallel parent support treatment
Not Eligible

You will not qualify if you...

  • Insufficient understanding of Swedish to complete study tasks
  • Currently undergoing Acceptance and Commitment Therapy or Cognitive Behavioral Therapy treatment
  • Using pain-relieving medication or having unstable medication regimens
  • No access to a smartphone or computer with internet and e-ID

AI-Screening

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Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Vallentuna, Sweden, 18647

Actively Recruiting

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Research Team

C

Charlotte Gentili, Licensed Psychologist, PhD

CONTACT

A

Aleksi Bell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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