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Search / Trial NCT05863897

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

Launched by UNIVERSITEIT LEIDEN · May 8, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Intervention E Health Rehabilitation Feasibility

ClinConnect Summary

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 predete...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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

About Universiteit Leiden

Universiteit Leiden, a prestigious academic institution in the Netherlands, is dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration and a commitment to ethical standards, the university leverages its extensive expertise in various fields, including medicine, pharmacology, and public health, to drive impactful research initiatives. By fostering partnerships with healthcare professionals and industry stakeholders, Universiteit Leiden aims to contribute to the development of novel therapies and enhance clinical outcomes, ultimately benefiting patients and the broader scientific community.

Locations

Wijk Aan Zee, Noord Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Aglaia M. Zedlitz, Dr.

Study Chair

Leiden University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported