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

NCT05863897 | Enrolling By Invitation

• 1 other identifier: e-COGRAT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Acquired Brain Injury; Fatigue

Keywords

Intervention; eHealth; Rehabilitation; Feasibility

Outcome Measures

Primary Outcomes (1)

• Daily fatigue

  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.

  1 year (daily in baseline and intervention phase and daily in the last week of follow-up)

Secondary Outcomes (6)

• Fatigue after ABI

  1 year (once in baseline, treatment and 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)

• Level of participation

  1 year (once in baseline, treatment and follow-up)

• Feasibility of the overall online intervention

  1 year (once in treatment and follow-up)

Study Arms (1)

eCOGRAT

EXPERIMENTAL

Behavioral: e-COGRAT (a blended eHealth intervention)

Interventions

e-COGRAT (a blended eHealth intervention) BEHAVIORAL

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.

eCOGRAT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Leiden: lead
• Heliomare Revalidatie: collaborator

Study Sites (1)

Heliomare

Wijk aan Zee, North Holland, 1949EC, Netherlands

Location

Related Publications (10)

• Zedlitz AM, Rietveld TC, Geurts AC, Fasotti L. Cognitive and graded activity training can alleviate persistent fatigue after stroke: a randomized, controlled trial. Stroke. 2012 Apr;43(4):1046-51. doi: 10.1161/STROKEAHA.111.632117. Epub 2012 Feb 2.

  PMID: 22308241 BACKGROUND

• Visser-Keizer AC, Hogenkamp A, Westerhof-Evers HJ, Egberink IJ, Spikman JM. Dutch multifactor fatigue scale: a new scale to measure the different aspects of fatigue after acquired brain injury. Arch Phys Med Rehabil. 2015 Jun;96(6):1056-63. doi: 10.1016/j.apmr.2014.12.010. Epub 2015 Jan 2.

  PMID: 25559057 BACKGROUND

• Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70. doi: 10.1017/s0033291796004382.

  PMID: 9089829 BACKGROUND

• van der Zee CH, Priesterbach AR, van der Dussen L, Kap A, Schepers VP, Visser-Meily JM, Post MW. Reproducibility of three self-report participation measures: The ICF Measure of Participation and Activities Screener, the Participation Scale, and the Utrecht Scale for Evaluation of Rehabilitation-Participation. J Rehabil Med. 2010 Sep;42(8):752-7. doi: 10.2340/16501977-0589.

  PMID: 20809057 BACKGROUND

• Ali A, Morfin J, Mills J, Pasipanodya EC, Maas YJ, Huang E, Dirlikov B, Englander J, Zedlitz A. Fatigue After Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):E249-E257. doi: 10.1097/HTR.0000000000000710. Epub 2021 Aug 4.

  PMID: 34354018 BACKGROUND

• Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.

  PMID: 29215315 BACKGROUND

• Ford ME, Geurtsen GJ, Groet E, Rambaran Mishre RD, Van Bennekom CAM, Van Someren EJW. A blended eHealth intervention for insomnia following acquired brain injury: a randomised controlled trial. J Sleep Res. 2023 Feb;32(1):e13629. doi: 10.1111/jsr.13629. Epub 2022 May 31.

  PMID: 35641443 BACKGROUND

• Theadom A, Barker-Collo S, Jones K, Dudley M, Vincent N, Feigin V. A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury. Clin Rehabil. 2018 May;32(5):619-629. doi: 10.1177/0269215517736671. Epub 2017 Oct 26.

  PMID: 29072086 BACKGROUND

• van Beugen S, Ferwerda M, Hoeve D, Rovers MM, Spillekom-van Koulil S, van Middendorp H, Evers AW. Internet-based cognitive behavioral therapy for patients with chronic somatic conditions: a meta-analytic review. J Med Internet Res. 2014 Mar 27;16(3):e88. doi: 10.2196/jmir.2777.

  PMID: 24675372 BACKGROUND

• Janse A, Worm-Smeitink M, Bleijenberg G, Donders R, Knoop H. Efficacy of web-based cognitive-behavioural therapy for chronic fatigue syndrome: randomised controlled trial. Br J Psychiatry. 2018 Feb;212(2):112-118. doi: 10.1192/bjp.2017.22.

  PMID: 29436329 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Fatigue

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aglaia M. Zedlitz, Dr.

  Leiden University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A single-case experimental design with AB and follow-up phases across participants.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 18, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

NL (1)