Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy.

Area of Science:

• Neurology
• Psychiatry
• Digital Health

Background:

• Depression affects approximately one in three individuals with epilepsy (PwE), leading to significant suffering and impaired quality of life.
• Despite effective treatments, depression in PwE is often undertreated due to concerns about drug interactions or antidepressant side effects.
• Internet-administered psychological interventions show promise as an adjunct to standard care for PwE.

Purpose of the Study:

• To evaluate the efficacy of a novel, internet-administered psychological intervention for reducing depression and anxiety in persons with epilepsy (PwE).
• To assess the intervention's impact on work and social adjustment, epilepsy symptoms, medication adherence, and quality of life in PwE.
• To determine if the internet intervention, as an adjunct to treatment as usual, can achieve sustained symptom reduction.

Main Methods:

• A randomized controlled trial involving 200 participants with epilepsy and current depressive disorder (PHQ-9 score ≥ 10).
• Participants were recruited from epilepsy treatment centers and online sources in German-speaking countries.
• The intervention group received six-month access to the internet intervention alongside care-as-usual, while the control group received care-as-usual/waitlist.

Main Results:

• The primary outcome measure is the Patient Health Questionnaire (PHQ-9) score at three months post-baseline.
• Secondary outcomes include self-reported anxiety, work and social adjustment, epilepsy symptoms, medication adherence, and quality of life.
• Data collection occurred online at baseline, three, six, and nine months.

Conclusions:

• This trial is expected to provide valuable insights into effective and efficient treatment strategies for comorbid depression and anxiety in persons with epilepsy.
• Findings will contribute to the evidence base for digital mental health interventions in neurological populations.
• The study aims to inform clinical practice by offering a potentially accessible and effective treatment option for PwE experiencing depression.