Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression
Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression
The trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect),
 which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to
 Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current
 depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and
 randomized to two groups: (1) a control group, in which they may engage with any epilepsy
 treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three
 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately
 receives six-month access to Desiconnect and may also use CAU. The primary outcome measure is
 the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three months
 post-baseline.
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 concerns over drug
 interactions. Previous studies strongly suggest that cognitive behavioral therapy (CBT) can
 help alleviate depression in PwE, but CBT is not always available to patients.
 Internet-administered psychological interventions are easily accessible and might complement
 antidepressant medication or psychotherapy, and preliminary evidence suggests that such
 interventions can be effective. However, no trial has yet examined whether a CBT-based
 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.

 The Internet-based intervention evaluated in this trial was designed with the aim of
 conveying evidence-based psychotherapeutic techniques, gleaned primarily from CBT, to PwE
 over a period of 180 days. The intervention focuses on identifying and challenging cognitions
 that trigger or sustain depression and anxiety, increasing activities that are likely to
 reduce depression and anxiety, practicing relaxation and stress management exercises and
 increasing mindfulness skills. The program is based on general CBT and other evidence-based
 psychotherapeutic techniques that have been shown to be helpful for patients suffering from
 depression (and ideally, that have been shown to be helpful among PwE). Furthermore, program
 content addresses other issues in disease self-management, including lifestyle habits (e.g.,
 nutrition, exercise) and medication adherence. The delivery and training of content is
 continuously individualized to match users' preferences and needs, based on responses within
 the program. The intervention is delivered via the Internet and protected by individually
 assigned passwords.

 This randomized controlled trial will include 200 participants with epilepsy and a current
 depressive disorder, along with currently at least moderately elevated depression.
 Participants will be recruited from various settings, including epilepsy treatment clinics,
 outpatient treatment centers, and Internet forums/groups. Methods such as newspaper articles,
 flyers, posters, and media articles or web-advertisements will be used to inform potential
 participants about the study (all material will be in German). Participants will be randomly
 assigned to either (1) a control group, in which they receive care as usual (CAU) and are
 given access to the internet intervention (Desiconnect) after a delay of 3 months (i.e.,
 CAU/Wait list 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
 (Desiconnect). Measurements are collected online at pre-treatment (baseline, T0), three
 months (T1), six months (T2), and nine months (T3).
Inclusion Criteria:

 -  Age at least 18 years

 -  diagnosis of active epilepsy (that is, at least one epileptic seizure within the past
 10 years or taking antiseizure medicines within the past five years)

 -  current depressive disorder (either major depressive disorder or dysthymic disorder,
 as determined by telephone interview with the MINI Neuropsychiatric Interview)

 -  no current antidepressant medication, or current antidepressant medication but no
 changes in dosage for at least one month prior to study inclusion (medication changes
 after study inclusion are permitted, given the pragmatic design of the trial)

 -  currently at least moderate self-reported depressive symptom severity, as
 operationalized by a score of at least 10 on the PHQ-9, a cut-off score that has been
 well validated

 -  ability to speak and read German

 -  access to the internet and personal possession of an appropriate device on which the
 internet-based intervention can be used regularly (e.g., smartphone, computer, laptop)

 -  expressed motivation to participate in the trial and use an internet-based
 intervention to acquire skills and knowledge that may aid in the amelioration of
 depression symptoms

 Exclusion Criteria:

 -  current psychotherapy

 -  other known major psychiatric disorder, such as bipolar disorder, schizophrenia or
 another psychotic disorder, or borderline personality disorder (based on the MINI
 interview)

 -  acute suicidality (that is, intention or plan to commit suicide, as assessed with the
 respective module of the MINI interview)

 -  newly prescribed antidepressant medication or change in antidepressant medication
 dosage in month prior to study inclusion