Internet-delivered ACT for PTSD and Chronic Pain : a Development Pilot Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- PTSD diagnostic status as measured by the Clinician-Administered PTSD Scale (CAPS)
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 PTSD and comorbid chronic pain. First, a pilot study (no randomization; N=10) will be conducted to test the intervention and assessment procedures. This will be followed by a randomized controlled trial with waitlist control. 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 PTSD and comorbid chronic pain.
Sample size: 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 collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up.
Assessment includes:
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a CAPS of ≥25
- •subjected to single traumatic events
- •were able to understand Swedish
- •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 (ongoing substance dependence, 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 emotional outbursts or 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 (indicated by the MINI and a score of 3 to item 9 of the Patient Health Questionnaire 9-item version (PHQ9))
结局指标
主要结局
PTSD diagnostic status as measured by the Clinician-Administered PTSD Scale (CAPS)
时间窗: Baseline, two-week-post treatment.
(changes between assessments) The scale assesses the presence of the DSM-5 PTSD criteria A-J.
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) and the Life Events Checklist (LEC-5)
时间窗: Baseline, two-week-post treatment, 3 month-follow-up.
(changes between assessments) The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
次要结局
- Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Acceptance as measured by the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Pain interference as measured by the Multidimensional Pain Inventory (MPI)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Pain intensity as measured by the Numerical Rating Scale (NRPS)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Perceived health as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36)(Baseline, two-week-post treatment, 3 month-follow-up.)
- Number of adverse events reported by the participant(2-week-post treatment.)
- Health care utilization, pharmaeconomics, medication use, and return to work as measured by the MiDAS-database of the Swedish Social Insurance Agency, the Swedish Prescribed Drug Register and health-care database of Region Skåne(Baseline, two-week-post treatment, 3 month-follow-up.)
研究者
Sophia Åkerblom
Prinicpal Investigator
Skane University Hospital