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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05863897
• Other study ID #: e-COGRAT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Universiteit Leiden
• Contact: Michelle Bertelkamp, MSc
• Phone: +31 88 9208374
• Email: m.bertelkamp[@]heliomare.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Fatigue
• Wounds and Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Leiden	Heliomare Revalidatie

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year (once in baseline, treatment and follow-up)
Secondary	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).	1 year (once in baseline, treatment and follow-up)
Secondary	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).	1 year (once in baseline, treatment and follow-up)
Secondary	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).	1 year (once in baseline, treatment and follow-up)
Secondary	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.	1 year (once in treatment and follow-up)
Secondary	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.	1 year (weekly during treatment and after follow-up)