Internet-Delivered Acceptance and Commitment Therapy (iACT) for Youth With PTSD and Chronic Pain
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sophia Åkerblom, Associate professor
- Telefonní číslo: 0046707790415
- E-mail: sophia.akerblom@skane.se
Studijní místa
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-
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Lund, Švédsko
- Nábor
- Department of pain rehabilitation
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Kontakt:
- Sophia Åkerblom, phd
- Telefonní číslo: 0046707790415
- E-mail: sophia.akerblom@skane.se
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: iACT
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Časové okno: Baseline, two-week-post treatment, 3 month-follow-up.
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The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Psychological inflexibility
Časové okno: Baseline, two-week-post treatment, 3 month-follow- up
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As measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52.
Higher scores indicate worse inflexibility
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Baseline, two-week-post treatment, 3 month-follow- up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Anxiety and depression
Časové okno: Baseline, two-week-post treatment, 3 month-follow up
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As measured by the Hospital Anxiety and Depression Scale (HADS) (changes between assessments) Min= 0; Max= 21.
Higher scores indicate worse depression/anxiety.
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Baseline, two-week-post treatment, 3 month-follow up
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Pain intensity
Časové okno: Baseline, two-week-post treatment, 3 month-follow- up
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As measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10.
Higher scores indicate worse pain intensity.
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Baseline, two-week-post treatment, 3 month-follow- up
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General acceptance
Časové okno: Baseline, two-week-post treatment, 3 month-follow-up
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As measured by the Swedish Acceptance and Action Questionnaire (SAAQ) (changes between assessments)
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Baseline, two-week-post treatment, 3 month-follow-up
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Parental psychological flexibility
Časové okno: Baseline, two-week-post treatment, 3 month-follow-up
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As measured by Parental Acceptance and Action Questionnaire (PAAQ)
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Baseline, two-week-post treatment, 3 month-follow-up
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Sophia Åkerblom, phd, Skane University Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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