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

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?

NCT Number	NCT05863897
Lead Sponsor	Universiteit Leiden Collaborators: Heliomare Revalidatie
Conditions	Acquired Brain Injury, Fatigue
Enrollment	16 participants
Start Date	2023-09-01
Primary Completion	2026-09 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-04-03