A study to evaluate a digital intervention for treating adjustment disorder in adults
| ISRCTN | ISRCTN55669001 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55669001 |
| Sponsor | Elona Health GmbH |
| Funder | Elona Health GmbH |
- Submission date
- 14/01/2026
- Registration date
- 15/01/2026
- Last edited
- 03/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Psychological help is not always readily available when patients need it, leaving many individuals struggling with their mental health without the support they require. The lack of immediate access to psychotherapy can contribute to the worsening of mental health conditions. In response to this challenge, the digital intervention "elona explore" was created as a low-threshold digital tool to offer psychological support, providing patients with immediate resources to manage their mental health and improve their well-being.
This study aims to evaluate the effects and safety of the digital intervention elona explore in addition to treatment-as-usual (TAU) compared to TAU alone. 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 over 18 years and diagnosed with adjustment disorders (F43.2 according to the ICD-10 criteria)
What does the study involve?
Participants will be enrolled in the study after psychotherapeutic consultation hour(s) at the study sites. Patients will be diagnosed during the consultation hour(s) by the psychotherapist, based on the Mini-DIPS and the SCID-5 adjustment disorder module.
Potential participants will be invited via online and offline advertising to the consultation hour(s) at the study sites. However, they will not be recruited from existing waiting lists of the study sites. Inclusion and exclusion criteria will be assessed by the participating therapist at the study site, who has received corresponding training on the study procedures.
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). Randomization to the study groups will be stratified according to study sites.
Participants assigned to the intervention group (IG) will receive access to the elona explore digital intervention in addition to TAU for 10 weeks, while participants assigned to the control group (CG) will only receive unrestricted access to TAU and will not use elona explore during the same period. CG will also be provided with elona explore application after 10 weeks, i.e., after the end of the study period.
Study assessments will be at baseline as part of the initial screening (T0), after 5 weeks (T1), and after 10 weeks (T2) of treatment. Patient-rated outcome measures will be collected through online questionnaires sent to patients by e-mail. Therapist-rated outcome measures will be conducted in on-site interviews with the patient held at T0, T1, and T2.
What are the possible benefits and risks of participating?
Participants in the IG may benefit from improvements in their perceived stress, general level of functioning, self- and therapist-rated symptoms of depression, self-rated symptoms of anxiety, quality of life, overall symptom alleviation, and social/occupational functioning, 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 evaluated to be minimal. Therefore, the expected benefits clearly outweigh the expected risks.
Where is the study run from?
Georg-August University of Göttingen (Germany)
When is the study starting and how long is it expected to run for?
February 2026 to December 2027
Who is funding the study?
Elona Health GmbH (Germany)
Who is the main contact?
Anika Meißner, anika.meissner@uni-goettingen.de
Contact information
Scientific, Public
Georg-August University of Göttingen
Georg-Elias-Müller Institute of Psychology
Department of Translational Psychotherapy
Kurze-Geismar-Str.1
Göttingen
37073
Germany
 ORCID ID |
0009-0002-5635-6463 |
|---|---|
| Phone | +495513929022 |
| anika.meissner@uni-goettingen.de |
Principal investigator
Georg-August University of Göttingen
Georg-Elias-Müller Institute of Psychology
Kurze-Geismar-Str. 1
Göttingen
37073
Germany
| ORCID ID |
0000-0003-3787-9576 |
|---|---|
| Phone | +49 (0)551 39 29020 |
| andre.pittig@uni-goettingen.de |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Health services research, Treatment | |
| Scientific title | A randomized controlled study to evaluate a digital intervention for the treatment of adjustment disorders in adults | |
| Study objectives | ||
| Ethics approval(s) |
Approved 16/12/2025, Ethics Committee of the Georg Elias Müller Institute for Psychology (Georg-August-Universität Göttingen, Georg-Elias-Müller-Institut für Psychologie, Goßlerstraße 14, Goettingen, 37073, Germany; +49 551 39 - 21110; ethikkommission@psych.uni-goettingen.de), ref: 464 | |
| Health condition(s) or problem(s) studied | Adjustment disorders (F43.2 based on ICD-10 criteria) | |
| Intervention | elona explore is a digital health application that provides patients with mental health disorders (depression, anxiety/panic disorders, OCD, adjustment disorders, burnout and somatoform disorders) with interventions, techniques, helpful activities, exercises, and psychoeducational resources. 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 efficacy and safety of elona explore, a randomized controlled trial (RCT) with patients with a clinical diagnosis of adjustment disorder (F43.2 based on ICD-10 criteria) is planned. The RCT comprises two arms: Participants assigned to the intervention group (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 control group (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 3 (time: baseline (week 0), 5 weeks, 10 weeks) study design will be used. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | elona explore | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
Updated 30/01/2026. Previous key secondary outcomes: | |
| Completion date | 15/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 112 |
| Key inclusion criteria | All subjects must have been diagnosed with the following ICD-10 diagnosis: F43.2: Adjustment disorders Subjects further need to: 1. Be over the age of 18 years 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 5. Be willing to comply with the protocol |
| Key exclusion criteria | All individuals without the included ICD-10 diagnosis, as well as individuals with the following comorbid 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 Further exclusion criteria are as follows: 1. Patients who are currently undergoing psychotherapy (at the point of enrollment) 2. Patients who plan to terminate or change the dose of their current medication that was prescribed for a mental health disorder, or those who plan to start taking a prescription medication prescribed for a mental health disorder within the next 10 weeks (a stable dose of medication three months before enrollment in trial is allowed). 3. Patients who are currently using a digital health application for a mental health disorder (at the point of enrollment) 4. Individuals with acute suicidality (assessed via suicidality screening of the mini-DIPS at the initial screening) 5. If an individual is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study is not possible. 6. If an individual underwent psychotherapy three months prior to enrolling, study participation is not possible. 7. It should be noted that the influence of concomitant treatments (especially psychotherapy) is intended to be reduced. Therefore, patients should not be recruited from an existing waiting list. |
| Date of first enrolment | 04/02/2026 |
| Date of final enrolment | 30/09/2027 |
Locations
Countries of recruitment
- Germany
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
03/02/2026: The date of first enrolment was changed from 14/01/2026 to 04/02/2026.
30/01/2026: Key secondary outcome(s) were updated.
15/01/2026: Study’s existence confirmed by the Ethics Committee of the Georg Elias Müller Institute for Psychology, Germany.
