Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression

NCT02791724 | Completed

• 1 other identifier: EP28b_01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• NDDIE (Neurological Disorders Depression Inventory for Epilepsy)

  Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)

• GAD-7 (Generalized Anxiety Disorder Questionnaire)

  Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)

• DASS-21 (Depression and Anxiety Scales)

  Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)

• WSAS (Work and Social Adjustment Scale)

  Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)

• Subjective usefulness of the program

  Assessed at 3 and 6 months

Study Arms (2)

Desiconnect

EXPERIMENTAL

Desiconnect is an Internet-administered intervention developed for persons with epilepsy and elevated depression symptoms.

Behavioral: Desiconnect; Other: CAU

Care-as-Usual (CAU) / wait list

ACTIVE COMPARATOR

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

Interventions

Desiconnect BEHAVIORAL

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.

Desiconnect

CAU OTHER

Care as Usual

Care-as-Usual (CAU) / wait list; Desiconnect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaia AG: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

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

Hamburg, Germany

Location

Related Publications (2)

• 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.

  PMID: 28173780 BACKGROUND

• 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.

  PMID: 30802941 RESULT

MeSH Terms

Conditions

Depression; Epilepsy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yvonne Nestoriuc, Ph.D.

  University Medical Center Hamburg-Eppendorf (UKE), Department of Psychosomatic Medicine and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 7, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)