e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

e-COGRAT (a blended eHealth intervention): The blended eHealth intervention for fatigue complaints after ABI, e-COGRAT, is a cognitive behaviorial intervention. It consists of 12 weekly sessions, including 6 individual online sessions, 2 face-to-face group sessions and 4 online group sessions, in 4 groups of 4 patients.

Study summary

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?

Eligibility

Primary outcome measure(s)

• Daily fatigue — 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.

Trial sites (1)

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