University Medical Center Hamburg-Eppendorf (UKE), Department of Psychiatry and Psychotherapy
Hamburg, Germany
NCT Number: NCT02791724
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hamburg, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Desiconnect is an Internet intervention for persons with epilepsy and elevated depression. Content is continuously adapted to patients' concerns and needs. Techniques to overcome depression (e.g., cognitive restructuring, behavioral activation) and to cope with anxiety symptoms (e.g., exposure, role of avoidance, mindfulness exercises) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Topics covered also include coping with epilepsy symptoms, identifying and coping with seizure auras and triggers, and the role of nutrition and exercise. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 180 days after registration.
Care as Usual
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Self-report depression symptom severity measure
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Epilepsy-specific self-report measure of depression symptom severity
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Self-report anxiety symptom severity measure
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Self-report measure of anxiety, depression, and stress symptoms
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Self-report measure of depression-related psychosocial impairment
Time frame: Assessed at 3 and 6 months
Individually designed self-report items
Time frame: Assessed at 3 and 6 months
Adapted self-report measure assessing potential negative effects of the Internet intervention
Time frame: Assessed at baseline, 3, 6, and 9 months
Self-report measure of epilepsy symptoms
Time frame: Assessed at baseline, 3, 6, and 9 months
Self-report measure of epilepsy symptoms
Time frame: Assessed at baseline, 3, 6, and 9 months
Self-report measure of health-related quality of life
Time frame: Assessed at baseline, 3, 6, and 9 months
Self-report measure of epilepsy self-management practices
Gaia AG
Industry
Evaluating a Novel Cognitive-Behavioral Online Depression Intervention for Persons With Epilepsy (Desiconnect): Randomized Controlled Trial
Acronym: ENCODE
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