NCT07813728

Brief Summary

The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for youth with PTSD and comorbid chronic pain. A pilot study (no randomization; N=5-10) will be conducted to test the intervention and assessment procedures. The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
18mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Mar 2028

Study Start

First participant enrolled

September 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.

    Baseline, two-week-post treatment, 3 month-follow-up.

  • Psychological inflexibility

    As measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility

    Baseline, two-week-post treatment, 3 month-follow- up

Secondary Outcomes (3)

  • Anxiety and depression

    Baseline, two-week-post treatment, 3 month-follow up

  • Pain intensity

    Baseline, two-week-post treatment, 3 month-follow- up

  • General acceptance

    Baseline, two-week-post treatment, 3 month-follow-up

Other Outcomes (1)

  • Parental psychological flexibility

    Baseline, two-week-post treatment, 3 month-follow-up

Study Arms (1)

iACT

EXPERIMENTAL
Behavioral: iACT

Interventions

iACTBEHAVIORAL

The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.

iACT

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a CAPS of ≥25 and a diagnosis of PTSD
  • subjected to single traumatic events
  • aged 15-24 years
  • had symptoms of chronic pain that interfered significantly with everyday life
  • were fully examined medically and had received medical treatment if indicated
  • were able to be an active part of the rehabilitation process, regain functioning in different life areas and participate in treatment interventions for approximately 5 hours every week
  • stable dose of medication
  • able to read and write in Swedish
  • had access to a smart phone or computer with internet access

You may not qualify if:

  • repeated and extensive traumatic events
  • had other acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ADHD, autism spectrum disorder, untreated bipolar disorder, OCD, psychotic symptoms, severe depression, )
  • were actively abusing analgesic medications (including narcotics), alcohol or other drugs
  • had great difficulty to harbour and handle strong emotions that could lead to self-harming behavior
  • had health risks due to medical reasons
  • had social or economic difficulties or lack of social support that hindered behavior change
  • current severe suicidal ideation that warranted immediate intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pain rehabilitation

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic PainStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Sophia Åkerblom, phd

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Åkerblom, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 10, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations