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



This 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).



Results 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.



ClinicalTrials.gov: NCT02791724 . Registered 01 June 2016.
Research Department, Gaia Group, Gertigstr. 12-14, 22303, Hamburg, Germany. bjoern.meyer@gaia-group.com.|Department of Psychology, City, University of London, London, UK. bjoern.meyer@gaia-group.com.
Björn
0000-0003-1100-0260
B
Meyer
Research Department, Gaia Group, Gertigstr. 12-14, 22303, Hamburg, Germany.|Ashridge Business School, Berkhamsted, UK.
Mario
M
Weiss
Department of Neurology, Epilepsy-Center Berlin-Brandenburg, Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
Martin
M
Holtkamp
Schön Clinic Vogtareuth, Clinic for Eplilepsy, Krankenhausstraße 20, 83569, Vogtareuth, Germany.
Stephan
S
Arnold
Department of Neurology and Epileptology, Epilepsy-Center Hamburg, Evangelical Hospital Alsterdorf, Elisabeth-Flügge-Straße 1, 22337, Hamburg, Germany.
Katja
K
Brückner
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Johanna
J
Schröder
Research Department, Gaia Group, Gertigstr. 12-14, 22303, Hamburg, Germany.
Franziska
F
Scheibe
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf and Schön Klinik Hamburg Eilbek, Martinistraße 52, 20246, Hamburg, Germany.
Yvonne
Y
Nestoriuc
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000523:psychology / Q000628:therapy*; D004827:Epilepsy / Q000150:complications / Q000523:psychology*; D005260:Female; D006296:Health Services; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D011613:Psychotherapy / Q000379:methods*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000928:Antidepressive Agents
Anxiety; Depression; Epilepsy; Internet interventions