Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05863897
Other study ID # e-COGRAT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT04959214 - The Effect Of Progressıve Relaxatıon Exercıses N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Completed NCT04531891 - Utility and Validity of a High-intensity, Intermittent Exercise Protocol N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT04960865 - Kinesio Taping and Calf Muscle Fatigue N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A
Active, not recruiting NCT05344183 - Immediate and Short-term Effects of Low-level Laser N/A
Completed NCT04716049 - Effectiveness of Recovery Protocols in Elite Professional Young Soccer Players N/A
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05241405 - Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer N/A
Active, not recruiting NCT06074627 - Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes N/A
Completed NCT03943212 - The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis N/A
Recruiting NCT05567653 - Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers N/A
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT05002894 - Effect of Pilates Exercises On Fatigue In Post Menopausal Women N/A
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT02911649 - Reducing Sedentary Behaviour With Technology N/A
Completed NCT03216616 - Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases N/A
Completed NCT02321358 - Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors N/A