Internet-Delivered Acceptance and Commitment Therapy (iACT) for Youth With PTSD and Chronic Pain
研究概览
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sophia Åkerblom, Associate professor
- 电话号码:0046707790415
- 邮箱:sophia.akerblom@skane.se
学习地点
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Lund、瑞典
- 招聘中
- Department of pain rehabilitation
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接触:
- Sophia Åkerblom, phd
- 电话号码:0046707790415
- 邮箱:sophia.akerblom@skane.se
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
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
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 |
|---|---|
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实验性的: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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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.
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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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety and depression
大体时间: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
大体时间: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
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parental psychological flexibility
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Sophia Åkerblom, phd、Skane University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SkaneU2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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