Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression (ENCODE)

Evaluating a Novel Cognitive-Behavioral Online Depression Intervention for Persons With Epilepsy (Desiconnect): Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Depression; Epilepsy
• Intervention / Treatment: Behavioral: Desiconnect; Other: CAU

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • University Medical Center Hamburg-Eppendorf (UKE), Department of Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desiconnect; Desiconnect is an Internet-administered intervention developed for persons with epilepsy and elevated depression symptoms.	Behavioral: Desiconnect; 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.; Other: CAU; Care as Usual
Active Comparator: Care-as-Usual (CAU) / wait list; In the CAU/wait list control group, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Desiconnect three months post-baseline (i.e., wait list with respect to Desiconnect access).	Other: CAU; Care as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9)	Self-report depression symptom severity measure	Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NDDIE (Neurological Disorders Depression Inventory for Epilepsy)	Epilepsy-specific self-report measure of depression symptom severity	Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
GAD-7 (Generalized Anxiety Disorder Questionnaire)	Self-report anxiety symptom severity measure	Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
DASS-21 (Depression and Anxiety Scales)	Self-report measure of anxiety, depression, and stress symptoms	Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
WSAS (Work and Social Adjustment Scale)	Self-report measure of depression-related psychosocial impairment	Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Subjective usefulness of the program	Individually designed self-report items	Assessed at 3 and 6 months
INEP (Inventory for the Assessment of Negative Effects of Psychotherapy)	Adapted self-report measure assessing potential negative effects of the Internet intervention	Assessed at 3 and 6 months
PESOS	Self-report measure of epilepsy symptoms	Assessed at baseline, 3, 6, and 9 months
LSSS (Liverpool Seizure Severity Scale)	Self-report measure of epilepsy symptoms	Assessed at baseline, 3, 6, and 9 months
QOLIE-10 (Health-related Quality of Life)	Self-report measure of health-related quality of life	Assessed at baseline, 3, 6, and 9 months
ESMS (Epilepsy Self-Management Scale)	Self-report measure of epilepsy self-management practices	Assessed at baseline, 3, 6, and 9 months

Collaborators and Investigators

• Sponsor: Gaia AG
• Collaborators: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Yvonne Nestoriuc, Ph.D., University Medical Center Hamburg-Eppendorf (UKE), Department of Psychosomatic Medicine and Psychotherapy

Publications and helpful links

General Publications

• Meyer B, Weiss M, Holtkamp M, Arnold S, Bruckner K, Schroder J, Scheibe F, Nestoriuc Y. Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy. BMC Psychiatry. 2017 Feb 7;17(1):55. doi: 10.1186/s12888-017-1229-y.
• Meyer B, Weiss M, Holtkamp M, Arnold S, Bruckner K, Schroder J, Scheibe F, Nestoriuc Y. Effects of an epilepsy-specific Internet intervention (Emyna) on depression: Results of the ENCODE randomized controlled trial. Epilepsia. 2019 Apr;60(4):656-668. doi: 10.1111/epi.14673. Epub 2019 Feb 25.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Epilepsy; Depression; Depressive Disorder
• Other Study ID Numbers: EP28b_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study