Internet-Delivered Acceptance and Commitment Therapy (iACT) for Youth With PTSD and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
iACT
干预措施: iACT (Behavioral)
结局指标
主要结局
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
时间窗: Baseline, two-week-post treatment, 3 month-follow-up.
The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
Psychological inflexibility
时间窗: 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
次要结局
- 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)
研究者
Sophia Åkerblom
Associate professor
Skane University Hospital