Trial results for a prospective case series examining standalone Cognitive Behavioral Therapy (CBT) components for Multiple Sclerosis fatigue were posted on ClinicalTrials.gov on 2025-11-26. The study found high intervention acceptability, with Cognitive Therapy components scoring a mean of 4.68 on a scale.
Background
Multiple Sclerosis (MS) is a chronic, often debilitating disease that affects the brain and spinal cord. One of the most common and impactful symptoms experienced by individuals with MS is fatigue, which can significantly impair daily activities and quality of life. Current management strategies for MS fatigue often involve a combination of pharmacological and non-pharmacological approaches. Cognitive Behavioral Therapy has shown promise in managing fatigue in various chronic conditions, and adapting these interventions for telehealth delivery could improve accessibility for patients with MS, who may face mobility challenges or live in remote areas.
Trial design
This completed prospective case series enrolled 21 participants with Multiple Sclerosis and Fatigue. The study aimed to refine and examine the feasibility, acceptability, and initial effects of three telehealth cognitive behavioral therapy components: relaxation training, behavioral activation, and cognitive therapy. The trial was designated as Phase NA, indicating it was not a traditional drug or device development phase study, but rather an exploratory investigation into therapeutic components.
Key results
The trial results provided several key measurements related to the acceptability, appropriateness, and feasibility of the intervention components, as well as initial fatigue scores:
- Intervention Acceptability (Relaxation Training): The mean score was 4.36 with a Standard Deviation of 0.70 units on a scale.
- Intervention Acceptability (Behavioral Activation): The mean score was 4.64 with a Standard Deviation of 0.48 units on a scale.
- Intervention Acceptability (Cognitive Therapy): The mean score was 4.68 with a Standard Deviation of 0.59 units on a scale.
- Intervention Appropriateness (Relaxation Training): The mean score was 4.14 with a Standard Deviation of 0.57 units on a scale.
- Intervention Appropriateness (Behavioral Activation): The mean score was 4.25 with a Standard Deviation of 0.74 units on a scale.
- Intervention Appropriateness (Cognitive Therapy): The mean score was 4.25 with a Standard Deviation of 0.78 units on a scale.
- Intervention Feasibility (Relaxation Training): The mean score was 4.46 with a Standard Deviation of 0.57 units on a scale.
- Intervention Feasibility (Behavioral Activation): The mean score was 4.39 with a Standard Deviation of 0.61 units on a scale.
- Intervention Feasibility (Cognitive Therapy): The mean score was 4.42 with a Standard Deviation of 0.66 units on a scale.
- Fatigue (Relaxation Training): The mean score was 44.29 with a Standard Deviation of 11.13 units on a scale.
- Fatigue (Behavioral Activation): The mean score was 49.38 with a Standard Deviation of 9.74 units on a scale.
- Fatigue (Cognitive Therapy): The mean score was 54.71 with a Standard Deviation of 20.15 units on a scale.
What this means
The posted results indicate that telehealth-delivered cognitive behavioral therapy components for fatigue in people with Multiple Sclerosis are highly acceptable, appropriate, and feasible. The consistently high mean scores across all three components (relaxation training, behavioral activation, and cognitive therapy) for acceptability, appropriateness, and feasibility suggest that these interventions are well-received by patients and can be practically implemented. Specifically, Cognitive Therapy showed the highest mean acceptability score of 4.68. These findings support the potential for integrating such telehealth CBT components into comprehensive fatigue management strategies for MS patients, potentially enhancing access to care and improving patient engagement with therapeutic interventions. While initial fatigue scores are provided, further research would be needed to assess the long-term efficacy of these components in reducing MS-related fatigue.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05848323, titled "Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue", were posted on 2025-11-26 on clinicaltrials.gov.