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

2026年9月4日 更新者: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.

研究概览

地位

招聘中

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Lund、瑞典
        • 招聘中
        • Department of pain rehabilitation
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Anxiety and depression
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Parental psychological flexibility
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sophia Åkerblom, phd、Skane University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月4日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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