e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Daily fatigue
研究概览
简要总结
Fatigue is a common, persistent consequence of acquired brain injury (ABI). Research into treatments that may alleviate post-ABI fatigue is been limited. Pharmacological treatment (methylphenidate) has shown the greatest scientific effects, but is complicated because the risk of adverse side effects and its potential for abuse. COGRAT, an evidence-based treatment combining cognitive therapy (CO) with graded activity training (GRAT), is found to be effective in treating fatigue in patients with acquired brain injury. However, therapist guided internet-based CBT (I-CBT) could offer a more accessible and cheaper alternative to this highly frequent face to face treatment. Moreover, I-CBT is found to be effective in a population with patients with psychiatric and chronic somatic disorders, including chronic fatigue syndrome. Recent studies suggests that I-CBT is effective for people with ABI as well. To obtain optimal benefit from both group delivered face to face therapy and e-health and to combine the available evidence of COGRAT and I-CBT in patients with ABI, we developed a blended e-health cognitive behavioral (group)intervention; e-COGRAT.
The goal of this intervention study is to evaluate the efficacy and feasibility of e-COGRAT to treat fatigue in people with ABI. The main questions it aims to answer are:
- Is a blended eHealth cognitive behavioral (group)intervention (e-COGRAT) effective as a treatment for fatigue in people with ABI?
- Is e-COGRAT the blended care variant of COGRAT, a cognitive behavioral group treatment for fatigue afer ABI, comparable to COGRAT in terms of efficacy?
- Will participants of e-COGRAT improve significant on overall fatigue, emotional well-being and participation?
- Will it be feasible for at least 80% of the participants to complete the intervention completely?
详细描述
A single case experimental design (SCED) with AB and follow-up phases across participants will be used. Within this study design, every participant will receive the blended eHealth cognitive behavioral (group)intervention (e-COGRAT). Patients who have given consent to participate in the study will be assigned to a treatment group by random assignment. Each group consists of 4 participants. Due to the group-based intervention all participants of each group will start simultaneously and immediately after baseline phase (2 weeks) with the 12-week intervention phase. Start dates will be predetermined based on the running dates of each group. The follow-up phase, immediately following after intervention phase, will take 24 weeks. The total duration of the study is 37 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An ABI diagnosis (stroke and traumatic brain injury) in the chronic phase (≥6 months after injury)
- •Complaints of severe fatigue (Checklist Individual Strength - subscale Fatigue score ≥ 40)
- •Full comprehension of Dutch language
- •Being cognitive capable of using the internet and having regular internet access.
排除标准
- •Having severe cognitive deficits (Behavioural Assessment of the Dysexecutive Syndrome (BADS) < borderline)
- •Having major untreated or unstable medical or psychiatric comorbidities (eg, epilepsy, psychosis)
- •Patients with (complaints of) depression are excluded if the depression subscale of the Hospital Anxiety and Depression Scale (HADS) is > 10
结局指标
主要结局
Daily fatigue
时间窗: 1 year (daily in baseline and intervention phase and daily in the last week of follow-up)
Primary outcome is the change in severity of fatigue complaints on a daily visual analogue scale (VAS) ("How would you rate your fatigue today?") which will be registered by text messages. Participants can indicate the severity of the experienced fatigue by given themselves a grade between 0 - 4. 0: "I'm not tired"; 1: "I'm a little bit tired"; 2: "tired"; 3: "pretty tired"; "; 4: "seriously tired". These grades will also be used in the intervention.
次要结局
- Level of participation(1 year (once in baseline, treatment and follow-up))
- Fatigue after ABI(1 year (once in baseline, treatment and follow-up))
- Feasibility of the overall online intervention(1 year (once in treatment and follow-up))
- Feasibility of each specific online session(1 year (weekly during treatment and after follow-up))
- Fatigue in the general population(1 year (once in baseline, treatment and follow-up))
- Emotional distress(1 year (once in baseline, treatment and follow-up))
研究者
Aglaia Zedlitz
Assistant Professor
Universiteit Leiden