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Acquired Brain InjuryNCT05863897

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

A study testing e-COGRAT (a blended eHealth intervention) in people with Acquired Brain Injury and Fatigue, run by Universiteit Leiden at 1 site in Netherlands.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acquired Brain Injury, Fatigue
What is being tested?
e-COGRAT (a blended eHealth intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNetherlands
Study dates
1 Sep 2023to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site

  • Heliomare

    Wijk aan Zee, North Holland, 1949EC

Other trials in Netherlands

About this study

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?
Read the detailed description

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.

Being tested
e-COGRAT (a blended eHealth intervention)
Keywords
Intervention, eHealth, Rehabilitation, Feasibility
Medical subject headings
Brain Injuries, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-COGRAT (a blended eHealth intervention)Behavioural

    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 groups in NCT05863897
Study groupRoleWhat they receive
eCOGRATExperimentalNot described
Receives: Behavioral: e-COGRAT (a blended eHealth intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Fatigue after ABI

    Fatigue after ABI will be assessed with the Dutch Multifactor Fatigue Scale (DMFS). The DMFS measures 5 aspects of fatigue regarding the four weeks preceding the assessment: Impact of fatigue, Mental fatigue, Signs and Direct consequences of fatigue, Physical fatigue and Coping with fatigue. The DMFS contains 38 items. Questions are answered on a 5-point Likert scale. Subscales of the DMFS showed sufficient to good reliability (Cronbach's alpha = 0.70 to 0.91), good convergent validity with an existing fatigue scale, and good divergent validity with measures of mood and self-esteem.

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

  2. Fatigue in the general population

    Fatigue in the general population will be assessed with the Checklist Individual Strength - subscale Fatigue (CIS-f). The CIS-f contains 8 questions on fatigue severity regarding the two weeks preceding the assessment. The CIS-f has good reliability and is sensitive to change. Questions are answered on a 7-point Likert scale (1-7, higher scores represent higher fatigue).

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

  3. Emotional distress

    Depression and anxiety symptoms of the last week will be assessed with the Dutch version of the 14-item Hospital Anxiety and Depression Scale (HADS). The reliability of the HADS is good (Cronbach's Alpha = 0.71 to 0.90) as is the test-retest reliability (0.86-0.90) (Spinhoven et al., 1997). Questions are answered on a 4-point Likert scale (0-3): 7 items on the depression subscale (HADS-D) and 7 items of the anxiety subscale (HADS-A). Subscale sumscores are categorized as normal (0-7), mild (8-10), moderate (11-14) or severe (15-21).

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

  4. Level of participation

    The Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) is a questionnaire to rate objective and subjective participation after rehabilitation. Internal consistency is satisfactory (Cronbach's Alpha = 0.70-0.91).

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

  5. Feasibility of the overall online intervention

    Feasibility will be assessed with structured interviews about overall usability, experienced benefits and difficulties and level of involvement. These interviews, for both participants and therapists, will take place posttreatment and after follow up.

    Measured: 1 year (once in treatment and follow-up)

  6. Feasibility of each specific online session

    After each online session both patients and therapists fill in a questionnaire with questions about their experiences with the specific session concerning usability, content, lay out, potential technical difficulties and other assorted comments.

    Measured: 1 year (weekly during treatment and after follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start1 Sep 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single-case experimental design with AB and follow-up phases across participants.
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05863897
Sponsor's protocol ID
e-COGRAT
Status last verified
Mar 2025
First submitted
14 Apr 2023
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22308241

  • 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.

    PubMed 25559057

  • 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.

    PubMed 9089829

  • 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.

    PubMed 20809057

  • 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.

    PubMed 34354018

  • 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.

    PubMed 29215315

  • 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.

    PubMed 35641443

  • 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.

    PubMed 29072086

  • 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.

    PubMed 24675372

  • 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.

    PubMed 29436329

Questions about this trial

What is this clinical trial studying?

A study testing e-COGRAT (a blended eHealth intervention) in people with Acquired Brain Injury and Fatigue, run by Universiteit Leiden at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily fatigue (time frame: 1 year (daily in baseline and intervention phase and daily in the last week of follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05863897, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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