Fatigue Clinical Trial
Official title:
e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
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?
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. ;
| 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 | |
| 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 |
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 | |
| Completed |
NCT03216616 -
Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases
|
N/A | |
| Completed |
NCT01919853 -
Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response
|
Phase 2 |