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

Abstract

BackgroundDepression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual.Methods/DesignThis randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected at three months post-baseline; secondary measures include self-reported anxiety, work and social adjustment, epilepsy symptoms (including seizure frequency and severity), medication adherence, potential negative treatment effects and health-related quality of life. Measurements are collected online at pre-treatment (T0), three months (T1), six months (T2), and nine months (T3).DiscussionResults of this trial are expected to extend the body of knowledge with regard to effective and efficient treatment options for PwE who experience elevated depression and anxiety.Trial registrationClinicalTrials.gov: NCT02791724. Registered 01 June 2016.

Effects of an epilepsy‐specific Internet intervention (Emyna) on depression: Results of the ENCODE randomized controlled trial

“…The intervention (termed Emyna) is described in the trial protocol; further details are provided in the online Appendix S1. 21 The intervention name "Emyna" was inspired by the Greek word "amyna," which in English denotes "defense," alluding to the idea that the program might help PwE to defend themselves against some of the adverse emotional effects wrought by epilepsy. In brief, Emyna is a fully automatic Internet intervention that requires no clinician support.…”

“…Outcome measures are described in detail in the trial protocol. 21 The primary outcome was depressive symptom severity, assessed at the before and after time points with two self-report measures: (1) the PHQ-9 and (2) the Neurological Disorders Depression Inventory for Epilepsy (NDDIE). Whereas the PHQ-9 is a generic self-report measure of depression symptoms, the NDDIE was developed specifically for PwE.…”

“…Secondary outcomes included (1) anxiety severity, measured with the Generalized Anxiety Disorder-7 items; (2) general distress (depression, stress, and anxiety), as assessed by the Depression Anxiety Stress Scales-21 items total score, which is more appropriate than subscale scores 25 ; (3) depression-related social-occupational impairment, measured by the Work and Social Adjustment Scale (WSAS); and (4) health-related quality of life in PwE, measured with the Quality of Life in Epilepsy-10 items (QOLIE-10). 21 As described in the protocol, subjective usefulness of the intervention as well as seizure frequency was measured with individually designed items. For seizure frequency, the following item was used: "How many debilitating seizures did you experience in the past month?…”

“…However, the effect size achieved in a trial with 76 PwE was small (Cohen d = 0.22 for the posttreatment group difference in depression severity), and participants noted that the intervention could have been better tailored to suit their illness‐specific needs . Based on these experiences, we developed a novel, epilepsy‐focused Internet intervention, which was evaluated in this RCT …”

“…18,19 Based on these experiences, we developed a novel, epilepsy-focused Internet intervention, which was evaluated in this RCT. 21 The primary hypothesis was that using this intervention adjunctively to care as usual (CAU) would result in greater depression reduction over 3 months than receiving only CAU. Secondarily, we hypothesized that intervention effects could be shown on several secondary outcomes, including anxiety, as detailed in the trial protocol and below.…”