Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Postcincussion symptom burden
研究概览
简要总结
The investigators aim to evaluate effects of an outpatient rehabilitation program based on Acceptance and Commitment Therapy compared to usual care on function in patients with post-concussion syndrome (PCS) and post-traumatic headache (PTH). This study builds on the investigators' previous observational studies and treatment studies in this patient group.
详细描述
The study is run in an outpatient setting at the Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway. All patients are also participants in the observational study: "Minimal and mild head injury: an exercise and outpatient follow-up study at St. Olavs Hospital" (REK number 2018/2159).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Having sustained a minimal HI or MTBI
- •PCS/ PTH had evolved within 1 week after the head trauma.
- •At least one post-concussion symptoms of at least moderate degree, that affects daily life.
- •> 6 months post-injury.
- •First line treatment has been tried, e.g. psychoeducation, increase of physical activity and pharmacological treatments for headache
排除标准
- •More than 5 years since last injury.
- •Symptoms are better explained by other conditions.
- •Severe communication problems, typically due to poor knowledge of Norwegian.
- •Severe psychiatric, neurological, somatic or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.
研究组 & 干预措施
Acceptance and Commitment Therapy
Participation in a 4 week group program based on Acceptance and Commitment Therapy, individual councelling and home lessions.
干预措施: Acceptance and Commitment Therapy (Behavioral)
control group
Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists.
结局指标
主要结局
Postcincussion symptom burden
时间窗: 3, 6 and 12 months after the intervention
The Rivermead postconcussion symptom questionnaire. The scale measures 13 common postconcussion somatic, emotional and cognitive symptoms on a range from 0 (no symptoms) to 64 (all symptoms graded as severe).
次要结局
- Headache(3, 6 and 12 months after the intervention)
- Work participation(3, 6 and 12 months after the intervention)