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Internet-Delivered Acceptance and Commitment Therapy (iACT) for Youth With PTSD and Chronic Pain

4 settembre 2026 aggiornato da: Sophia Åkerblom, Skane University Hospital
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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Objective: The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT) for youth with PTSD and comorbid chronic pain.

Sample size: 5-10 participants.

Trial design: All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit at Skåne University Hospital. The unit is a government supported, regional specialist center focused on assessment and treatment of chronic pain and related disability.

Assessments: Baseline and post treatment (2 weeks after treatment) assessments will be conducted by an assessor who is trained to administer the study measures. Self-report measures will also be collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up.

Pre-and post assessment: Assessors will collect demographic information, self-report measures, and trauma history. During the pre- and post-assessment the Clinician-Administered PTSD Scale for DSM-5 will be administered to establish PTSD whether participants met the DSM-5 criteria for PTSD.

During the pre-assessment a clinical interview will be administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.

Post-treatment exit interview: At the post-assessment, the assigned assessor will ask participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.

During treatment: During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment is following the introduction of the treatment rationale and the main treatment components (included in the internet program).

Safety parameters: As a mean to monitor safety and progress participants complete a short daily diary during the baseline and treatment phases. In addition, participants can report any adverse events during treatment, at post treatment and follow-up assessment.

Data collection: Self-report measures will be mailed to participants

A single-case design with daily data collection during a baseline phase (A) and an intervention phase (B) will also be used. The treatment intervention spans 10 weeks.

For the daily data collection, a shortened set of measures comprising approximately 10 items focusing on ptsd symptoms, psychological flexibility, and pain intensity will be used. Data will be collected via a digital platform, with secure handling of any personal data.

Main statistical analysis Between-group estimates on outcome will be conducted using repeated measurements. The analyses will be conducted using intention to treat principles and post hoc comparisons. Randomization test for the A/B single case data collection will be conducted.

Tipo di studio

Interventistico

Iscrizione (Stimato)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Svezia
      • Lund, Svezia
        • Reclutamento
        • Department of pain rehabilitation
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: iACT
Comportamentale: iACT
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Lasso di tempo: Baseline, two-week-post treatment, 3 month-follow-up.
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
Lasso di tempo: Baseline, two-week-post treatment, 3 month-follow- up
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety and depression
Lasso di tempo: Baseline, two-week-post treatment, 3 month-follow up
As measured by the Hospital Anxiety and Depression Scale (HADS) (changes between assessments) Min= 0; Max= 21. Higher scores indicate worse depression/anxiety.
Baseline, two-week-post treatment, 3 month-follow up
Pain intensity
Lasso di tempo: Baseline, two-week-post treatment, 3 month-follow- up
As measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity.
Baseline, two-week-post treatment, 3 month-follow- up
General acceptance
Lasso di tempo: Baseline, two-week-post treatment, 3 month-follow-up
As measured by the Swedish Acceptance and Action Questionnaire (SAAQ) (changes between assessments)
Baseline, two-week-post treatment, 3 month-follow-up

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Parental psychological flexibility
Lasso di tempo: Baseline, two-week-post treatment, 3 month-follow-up
As measured by Parental Acceptance and Action Questionnaire (PAAQ)
Baseline, two-week-post treatment, 3 month-follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Skane University Hospital

Investigatori

  • Investigatore principale: Sophia Åkerblom, phd, Skane University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 marzo 2028

Date di iscrizione allo studio

Primo inviato

4 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SkaneU2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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