Panic disorder and/or agoraphobia Mental and Behavioural Disorders
Conditions
Interventions
elona therapy is a digital health application that supports patients in outpatient psychotherapy in the treatment of mental illnesses (depression, anxiety/panic disorders, hypochondriacal disorders) t
Sponsors
Elona Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. All participants without the inclusion ICD-10 diagnosis criteria as well as participants with the following comorbid ICD-10 diagnoses are excluded: 1.1 F0x.x: Organic, including symptomatic, mental disorders 1.2. F1x.x Mental and behavioural disorders due to psychoactive substance use (except F17.x) 1.3. F2x.x: Schizophrenia, schizotypal and delusional disorders 1.4. F31: Bipolar affective disorder 1.5. F32.3: Severe depressive episode with psychotic symptoms 1.6. F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms 2. Individuals with acute suicidality (operationalized via BDI-II screening question greater than 1 or first checkup) are excluded from this study first checkup) 3. Participants under the age of 18 years 4. Participants without any access to a smartphone (iOS or Android operating system) with internet access 5. Participants without German language proficiency 6. Participants who are currently enrolled in a potentially confounding drug or device trial 7. Participants who plan to change the dose of their current psychiatric medication or start a new one during the study period (a stable dose of psychiatric medication is allowed)
Exclusion criteria
Exclusion criteria: 1. All participants without the inclusion ICD-10 diagnosis criteria as well as participants with the following comorbid ICD-10 diagnoses are excluded: 1.1 F0x.x: Organic, including symptomatic, mental disorders 1.2. F1x.x Mental and behavioural disorders due to psychoactive substance use (except F17.x) 1.3. F2x.x: Schizophrenia, schizotypal and delusional disorders 1.4. F31: Bipolar affective disorder 1.5. F32.3: Severe depressive episode with psychotic symptoms 1.6. F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms 2. Individuals with acute suicidality (operationalized via BDI-II screening question greater than 1 or first checkup) are excluded from this study first checkup) 3. Participants under the age of 18 years 4. Participants without any access to a smartphone (iOS or Android operating system) with internet access 5. Participants without German language proficiency 6. Participants who are currently enrolled in a potentially confounding drug or device trial 7. Participants who plan to change the dose of their current psychiatric medication or start a new one during the study period (a stable dose of psychiatric medication is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of panic and agoraphobia measured using the PAS online questionnaire at the beginning of the treatment and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of anxiety assessed with the Beck Anxiety Inventory (BAI) at the beginning of the treatment and after 8 weeks 2. Symptoms of depression assessed with the Beck Depression Inventory-II (BDI-II) at the beginning of the treatment and after 8 weeks 3. Physical health-related quality of life assessed with the World Health Organization Quality of Life-Brief version (WHOQOL-BREF) at the beginning of the treatment and after 8 weeks 4. Psychological health-related quality of life assessed with the World Health Organization Quality of Life-Brief version (WHOQOL-BREF) at the beginning of the treatment and after 8 weeks 5. Functional impairment of the patient assessed with the Work and Social Adjustment Scale (WSAS) at the beginning of the treatment and after 8 weeks 6. Adherence to treatment assessed through self and psychotherapist report using a self-validated 4-item instrument after 8 weeks In addition to that, psychotherapists participating in this study will fill out the following questionnaires for their patients: 7. Overall symptoms assessed by the clinician (assessed through Clinical Global Impression - Improvement (CGI-I)) at the beginning of the treatment and after 8 weeks 8. Improvement in the severity of their symptoms assessed by the clinician through Clinical Global Impression-Severity (CGI-S) at the beginning of the treatment and after 8 weeks Additionally, the study will evaluate whether the proportion of patients experiencing clinically significant improvements (i.e., =50% symptom reduction on the PAS) differs significantly between the two study groups after 8 weeks. | — |
Countries
Germany
Contacts
Public ContactEce Atik
Outcome results
None listed