A randomized controlled study to evaluate a digital intervention for treating anxiety disorders in adults
| ISRCTN | ISRCTN12481277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12481277 |
| Secondary identifying numbers | EX-M11ANX-CIP Version 1.1 |
- Submission date
- 06/07/2023
- Registration date
- 06/07/2023
- Last edited
- 07/03/2025
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Patients in need of psychotherapy typically have to wait a long time to start treatment. Long waiting times contribute to the chronification (transition from acute to chronic) of mental disorders if no treatment is provided during this time. This highlights the importance of providing patients with adequate treatment during this time so that patients have reduced symptoms, feel supported, stay on the waiting list, and eventually receive the psychotherapy they need. To address this need, the digital intervention 'elona explore' was created as a digital tool for treatment for patients during the waiting period.
The aim of this study is to evaluate the effectiveness and safety of the digital intervention elona explore in addition to treatment-as-usual (TAU) compared to TAU alone (i.e. waiting list for outpatient psychotherapy). Within TAU, patients are not restricted in the use of medical or psychological services that are available as usual care.
Who can participate?
Patients aged 18 - 65 years and diagnosed with an anxiety disorder (agoraphobia with or without panic disorder, social anxiety disorder, panic disorder)
What does the study involve?
Participants will be enrolled in the study after their first psychotherapeutic consultation hour(s) at the investigation sites, which will clarify the indication for psychotherapy. Patients will be diagnosed during the consultation hour(s), as decided by the treating psychotherapist on the basis of the Mini-DIPS. If the patient cannot be offered an immediate psychotherapy place, they will be referred to the waiting list of the investigation site and invited to the study if they have also been diagnosed as suitable for this study. If regular psychotherapy can be offered, they will not be considered for this study.
If a sufficient number of patients cannot be recruited from the waiting list of the investigation site, further potential participants will be invited to the consultation hour(s) via online and offline advertising. The same diagnostic assessment procedure (by the treating psychotherapist based on the Mini-DIPS) and recruitment procedure will apply to these participants.
Enrolment will take place after patients have been informed about the study and have signed the informed consent form at the study sites. After agreeing to take part in the study, participants will be randomized to one of the study conditions (intervention or control).
Participants assigned to the intervention group (IG) will receive access to the elona explore digital intervention in addition to TAU for a period of 10 weeks, while participants assigned to the control group (CG) will only receive TAU and will not use elona explore during the same time period.
What are the possible benefits and risks of participating?
Participants in the IG may benefit from improvements in their symptoms of anxiety and depression, improvements in disorder-specific symptoms of panic and agoraphobia or social anxiety, quality of life, social/occupational functioning, perceived self-efficacy, and mental health literacy compared to the CG. Patients may experience symptom worsening, perceived dependence on the digital intervention, anxiety, or confusion due to potential device malfunction or user error. The level of potential risk is judged to be minimal. Therefore, the expected benefits clearly outweigh the expected risks.
Where is the study run from?
Elona Health GmbH
When is the study starting and how long is it expected to run for?
February 2023 to June 2024
Who is funding the study?
Elona Health GmbH (Germany)
Who is the main contact?
Ece Atik, ece@elona.health
Contact information
Scientific
Elona Health GmbH
Schirmerstraße 61
Düsseldorf
40211
Germany
 ORCID ID |
0000-0002-1361-6301 |
|---|---|
| Phone | +49 (0)211 82268660 |
| ece@elona.health |
Study information
| Study design | Multicenter interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Other therapist office |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomized controlled study to evaluate a digital intervention for the treatment of anxiety disorders in adults |
| Study hypothesis | Effectiveness hypotheses: Primary hypothesis: P1: Patients receiving access to elona explore in addition to TAU experience greater improvements in symptoms of anxiety (assessed with the Beck Anxiety Inventory (BAI)) compared to patients receiving TAU over 10 weeks of treatment. Secondary hypotheses: S1: Patients receiving access to elona explore in addition to TAU experience greater improvements in symptoms of depression (assessed with the Patient Health Questionnaire-9 (PHQ-9)) compared to patients receiving TAU over 10 weeks of treatment. S2a (only patients with F40.00, F40.01, or F41.0): Patients receiving access to elona explore in addition to the TAU experience greater improvements in panic and agoraphobia symptoms (assessed with the Panic and Agoraphobia Scale (PAS)) compared to patients receiving TAU over 10 weeks of treatment. S2b (only patients with F40.1): Patients receiving access to elona explore in addition to the TAU experience greater improvements in symptoms of social anxiety (assessed with the Liebowitz Social Anxiety Scale (LSAS)) compared to patients receiving TAU over 10 weeks of treatment. S3: Patients receiving access to elona explore in addition to TAU experience greater improvements in their quality of life (assessed with the World Health Organization-Brief Quality of Life Scale (WHOQOL-BREF) - Psychological health subscale) compared to patients receiving TAU over 10 weeks of treatment. S4: Patients receiving access to elona explore in addition to TAU experience greater improvements in work and social adjustment (assessed with the Work and Social Adjustment Scale (WSAS)) compared to patients receiving TAU over 10 weeks of treatment. S5: Patients receiving access to elona explore in addition to TAU experience greater improvements in their general self-efficacy (assessed with the General Self Efficacy Scale (GSE)) compared to patients receiving TAU over 10 weeks of treatment. S6: Patients receiving access to elona explore in addition to TAU experience greater improvements in their mental health literacy (assessed with the Mental Health Literacy Scale (MHLS)) compared to patients receiving TAU over 10 weeks of treatment. Additionally, the proportion of patients who demonstrate a clinically significant improvement in the BAI will be compared between the two intervention conditions. Safety hypothesis: P1: Patients receiving access to elona explore in addition to the TAU do not experience a higher number of or more serious adverse events than TAU. Mixed linear models with the intention-to-treat (ITT) data set will be used as the primary method of data analysis. For the missing values, multiple imputation will be used. In addition, per-protocol (PP) analyses will be performed as an additional sensitivity analysis. Primary and secondary hypotheses will be tested in a fixed sequence procedure (hierarchical testing), where they will be tested in the predefined order until the first non-significant result. |
| Ethics approval(s) |
Approved 16/05/2023, Ethics Committee University of Mannheim (Ethikkommission Schloss, Mannheim, 68161, Germany; N/A; ethik@mail.uni-mannheim.de), ref: EK Mannheim 17/2023 |
| Condition | Treatment of anxiety disorders in patients on the waiting list for the outpatient psychotherapeutic treatment |
| Intervention | elona explore is a digital health application that provides patients with mental health disorders (depression, anxiety/panic disorders, OCD, adjustment disorders, and somatoform disorders) with interventions, techniques, helpful activities, exercises, and psychoeducational resources for the period they are on the waiting list for outpatient psychotherapy. By retrieving regular check-ups, elona explore responds individually to patients’ mood records and adjusts the content accordingly. The application is intended for independent use by the patient and to assist in the self-management of symptoms of the patient’s mental disorder. The treatment elements of elona explore are in line with current recommendations for the psychotherapeutic treatment of common mental disorders. To test the effectiveness and safety of elona explore, a randomized controlled trial (RCT) with patients who are on the waiting list for outpatient psychotherapy with a clinical diagnosis of an anxiety disorder (including F40.00, F40.01, F40.1, and F41.0 based on ICD-10 criteria) is planned. The RCT comprises two arms. Randomization will be achieved 1:1 and stratified according to the specific anxiety disorder group (Group 1: F40.00, F40.01, F41.0, and Group 2: F40.1). Participants assigned to the IG will receive access to the elona explore digital application in addition to the treatment as usual (TAU) for 10 weeks. Within TAU, patients are not restricted in the use of medical or psychological services that are available as usual care. The CG will receive only TAU for 10 weeks. The CG will receive access to the elona explore application after the study period. For evaluating the primary and secondary objectives of this study (see below) a 2 (group: IG, CG) x 2 (time: pre, post) design will be used. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | elona explore |
| Primary outcome measure | Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2): Primary effectiveness objective: Symptoms of anxiety measured using BAI Primary safety objective: Number and seriousness of adverse events measured using patient records |
| Secondary outcome measures | Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2): 1. Symptoms of depression measured with the PHQ-9 2. Symptoms of panic and agoraphobia or social anxiety measured with the PAS or the LSAS 3. Psychological health measured with the psychological health subscale of the WHOQOL-BREF 4. Work and social maladjustment measured with the WSAS 5. Self-efficacy measured with the GSE 6. Mental health literacy measured with the MHLS |
| Overall study start date | 01/02/2023 |
| Overall study end date | 30/06/2024 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 158 participants (79 in each group) |
| Participant inclusion criteria | All subjects must have been diagnosed with one of the following ICD-10 diagnoses: F40.00: Agoraphobia: Without history of panic disorder F40.01: Agoraphobia: With panic disorder F40.1: Social phobia F41.0: Panic disorder (episodic paroxysmal anxiety) Subjects further need to: 1. Be at least 18 years old 2. Possess sufficient German language skills (in writing and reading) 3. Possess a smartphone (iOS or Android operating system) with internet access 4. Provide signed and dated informed consent and be willing to comply with the protocol |
| Participant exclusion criteria | All subjects without the inclusion ICD-10 diagnosis criteria, as well as subjects with the following ICD-10 diagnoses, are excluded: F00-F09: Organic, including symptomatic, mental disorders F10-F19 Mental and behavioural disorders due to psychoactive substance use (except F17.1, F17.2, F17.3) F20-F29: Schizophrenia, schizotypal and delusional disorders F30: Manic episode F31.0, F31.1, F31.2, F31.5, F31.6, F31.8, F31.9: Bipolar disorder current hypomanic or manic episode F32.3: Severe depressive episode with psychotic symptoms F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms 1. Subjects with acute suicidality (assessed via suicidality screening of the mini-DIPS at the initial screening) 2. Subjects under the age of 18, subjects without any access to a smartphone (iOS or Android operating system) with internet access 3. Subjects without German language proficiency If a subject is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study needs to be pre-approved by the principal investigator. |
| Recruitment start date | 12/07/2023 |
| Recruitment end date | 30/03/2024 |
Locations
Countries of recruitment
- Germany
Study participating centres
Düsseldorf
40212
Germany
Köln
50677
Germany
Köln
50672
Germany
Sponsor information
Industry
Schirmerstraße 61
Düsseldorf
40211
Germany
| Phone | +49 (0)211 82 26 86 60 |
|---|---|
| info@elona.health | |
| Website | https://www.elona.health/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results are planned to be published in a peer-review academic journal after the end of the trial. |
| IPD sharing plan | Participant-level data (anonymized data) is available upon request from Ece Atik (ece@elona.health). |
Editorial Notes
07/03/2025: The study has been stopped due to a lack of resources.
06/07/2023: Study's existence confirmed by the Ethics Committee University of Mannheim.
