Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression

Depression Clinical Trial

— ENCODE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791724
• Other study ID #: EP28b_01
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2019
• Source: Gaia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf (UKE), Department of Psychiatry and Psychotherapy	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Gaia AG	Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Meyer B, Weiss M, Holtkamp M, Arnold S, Brückner K, Schröder 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: — View Citation

Meyer B, Weiss M, Holtkamp M, Arnold S, Brückner K, Schröder 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Subjective usefulness of the program	Individually designed self-report items	Assessed at 3 and 6 months
Secondary	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
Secondary	PESOS	Self-report measure of epilepsy symptoms	Assessed at baseline, 3, 6, and 9 months
Secondary	LSSS (Liverpool Seizure Severity Scale)	Self-report measure of epilepsy symptoms	Assessed at baseline, 3, 6, and 9 months
Secondary	QOLIE-10 (Health-related Quality of Life)	Self-report measure of health-related quality of life	Assessed at baseline, 3, 6, and 9 months
Secondary	ESMS (Epilepsy Self-Management Scale)	Self-report measure of epilepsy self-management practices	Assessed at baseline, 3, 6, and 9 months