A remotely delivered intervention targeting adults with persisting mild-to-moderate post-concussion symptoms (GAIN Lite): a study protocol for a parallel group randomised trial

Trials, 2024 · DOI: https://doi.org/10.1186/s13063-024-08546-3 · Published: October 8, 2024

Neurology Rehabilitation Telehealth & Digital Health

Simple Explanation

This study evaluates a new remote treatment (GAIN Lite) for adults experiencing ongoing symptoms after a concussion. Participants will be assigned to either receive enhanced usual care (EUC) or GAIN Lite in addition to EUC. The study aims to determine if GAIN Lite, which includes e-learning and remote counselling, can improve post-concussion symptoms and daily life limitations compared to standard care alone.

Study Duration

36 weeks

Participants

132 adults with mild-to-moderate PPCS

Evidence Level

Level 1: Randomized controlled superiority trial (RCT)

Key Findings

1
The study aims to evaluate the efficacy of GAIN Lite added to enhanced usual care (EUC) for adults with mild-to-moderate PPCS compared to EUC only.
2
The primary outcomes are mean changes in PPCS and limitations in daily life from baseline to 24 weeks after baseline.
3
GAIN Lite is a remote programme based on the treatment principles and content from GAIN with a duration of 8 weeks

Research Summary

The study is designed as an open-label, parallel-group, two-arm randomised controlled superiority trial (RCT) with 1:1 allocation ratio. Participants will be identified through hospital records or referred by general practitioners within 2–4 months post-concussion. The primary goal is to assess whether GAIN Lite improves PPCS and daily life limitations compared to enhanced usual care alone over a 24-week period.

Practical Implications

Improved Access to Care

Remote intervention may improve access to rehabilitation and prevent chronification.

Reduced Healthcare Demands

Improvements may reduce demands on the social and healthcare systems.

Evidence-Based Treatment

Results could add to the empirical evidence of the efficacy of cognitive and behavioural-based interventions.

Study Limitations

1
Evidence-based recommendations for effective non-pharmacological treatment for people with PPCS are sparse
2
Due to the nature of the intervention, neither participants nor providers can be blinded to allocation.
3
The data cannot be shared publicly due to existing data protection laws in Denmark

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