DepressionENCODENCT02791724
Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression
A study testing Desiconnect and CAU in people with Depression and Epilepsy, run by Gaia AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Epilepsy
- What is being tested?
- Desiconnect and CAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf (UKE), Department of Psychiatry and Psychotherapy
Hamburg
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression, Epilepsy
- Being tested
- Desiconnect, CAU
- Medical subject headings
- Depression, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesiconnectBehavioural
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.
CAUOther
Care as Usual
| Study group | Role | What they receive |
|---|---|---|
| Desiconnect | Experimental | Desiconnect is an Internet-administered intervention developed for persons with epilepsy and elevated depression symptoms. Receives: 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). Receives: Other: CAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9)
Self-report depression symptom severity measure
Measured: 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)
Epilepsy-specific self-report measure of depression symptom severity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at 3 and 6 months
PESOS
Self-report measure of epilepsy symptoms
Measured: Assessed at baseline, 3, 6, and 9 months
LSSS (Liverpool Seizure Severity Scale)
Self-report measure of epilepsy symptoms
Measured: Assessed at baseline, 3, 6, and 9 months
QOLIE-10 (Health-related Quality of Life)
Self-report measure of health-related quality of life
Measured: Assessed at baseline, 3, 6, and 9 months
ESMS (Epilepsy Self-Management Scale)
Self-report measure of epilepsy self-management practices
Measured: Assessed at baseline, 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Yvonne Nestoriuc, Ph.D., Principal investigator, University Medical Center Hamburg-Eppendorf (UKE), Department of Psychosomatic Medicine and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791724
- Sponsor's protocol ID
- EP28b_01
- Acronym
- ENCODE
- Status last verified
- Jul 2019
- First submitted
- 1 Jun 2016
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
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.
PubMed 28173780Meyer 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.
PubMed 30802941
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Cognitive-Behavioral Online Depression Intervention for Persons With Epilepsy (Desiconnect): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02791724
- Acronym / sponsor ID
- ENCODE / EP28b_01
- Conditions
- Depression, Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- Jun 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desiconnect | Experimental | Behavioral: Desiconnect, Other: CAUDesiconnect is an Internet-administered intervention developed for persons with epilepsy and elevated depression symptoms. |
| Care-as-Usual (CAU) / wait list | Active comparator | Other: CAUIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesiconnectDesiconnect 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. | Behavioural | Desiconnect |
| CAUCare as Usual | Other | Care-as-Usual (CAU) / wait list, Desiconnect |
Primary outcome
Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9)
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Self-report depression symptom severity measure
10 secondary outcomes
NDDIE (Neurological Disorders Depression Inventory for Epilepsy)
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
GAD-7 (Generalized Anxiety Disorder Questionnaire)
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
DASS-21 (Depression and Anxiety Scales)
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
WSAS (Work and Social Adjustment Scale)
Time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)
Subjective usefulness of the program
Time frame: Assessed at 3 and 6 months
INEP (Inventory for the Assessment of Negative Effects of Psychotherapy)
Time frame: Assessed at 3 and 6 months
PESOS
Time frame: Assessed at baseline, 3, 6, and 9 months
LSSS (Liverpool Seizure Severity Scale)
Time frame: Assessed at baseline, 3, 6, and 9 months
QOLIE-10 (Health-related Quality of Life)
Time frame: Assessed at baseline, 3, 6, and 9 months
ESMS (Epilepsy Self-Management Scale)
Time frame: Assessed at baseline, 3, 6, and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 28173780Meyer 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.
- Results publication: PubMed 30802941Meyer 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.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Nestoriuc, Ph.D. principal investigator
University Medical Center Hamburg-Eppendorf (UKE), Department of Psychosomatic Medicine and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desiconnect and CAU in people with Depression and Epilepsy, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9) (time frame: Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.