A Pilot Study of Internet-based ACT for Endometriosis 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
- Pain interference as measured by the Multidimensional Pain Inventory (MPI)
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 endometriosis and chronic pain. A pilot study (no randomization; N=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 endometriosis and chronic pain, value-based exposure for 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 2 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 endometriosis.
Sample size 10 participants.
Trial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit and the team for endometriosis 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 posttreatment (2 weeks after treatment) assessments will be conducted. Self-report measures will also be collected at baseline, post-treatment as well as during a 3-month follow up.
Assessment includes:Pre-and post assessment Assessors collected demographic information and self-report measures. During the pre-assessment the Mini International Neuropsychiatric Interview 5.0 (MINI) was administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •verified endometriosis
- •age between 18-65 years
- •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
- •had 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, PTSD)
- •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))
研究组 & 干预措施
treatment group
Acceptance and commitment therapy
干预措施: Acceptance and commitment therapy (Behavioral)
结局指标
主要结局
Pain interference as measured by the Multidimensional Pain Inventory (MPI)
时间窗: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up
(changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.
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)
- Pain intensity as measured by the Numerical Rating Scale (NRPS)(Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up)
- Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)(Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), 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)
- Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)(Baseline, two-week-post treatment, 3 month-follow- up)
- Health care utilization as measured by the health-care database of Region Skåne(Baseline, 3 month-follow- up)
- Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)(Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up)
- Health-related quality of life as measured by the Endometriosis Health Profile (EHP-30)(Baseline, two-week-post treatment, 3 month-follow- up)
研究者
Sophia Åkerblom
Associate professor
Skane University Hospital