Improving the effectiveness of cognitive based therapy for depression with digital interventions: findings from a randomized control trial
| ISRCTN | ISRCTN11129335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11129335 |
| Secondary identifying numbers | Dep_RCT_1 |
- Submission date
- 07/02/2023
- Registration date
- 08/02/2023
- Last edited
- 17/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
elona therapy is the first digital health application (DiGA) for therapy support in the treatment of depression and is reimbursed by all statutory health insurers in Germany. Psychotherapists can individualize the available content based on the progress of the therapy. This study follows a pilot study (https://www.isrctn.com/ISRCTN16328317) and aims to evaluate the efficacy and safety of the digital health application elona therapy (Depression module) for blended cognitive behavioral therapy (bCBT) compared to standard cognitive behavioral therapy (CBT) for depression.
Who can participate?
Patients aged 18 - 65 years with a unipolar depressive disorder
What does the study involve?
Participants will either receive bCBT with elona therapy or standard CBT over 12 weeks. All patients will fill out online questionnaires at the beginning (week 0) and at the end (week 12) of the study period.
What are the possible benefits and risks of participating?
During the use of the application, all participants will receive the usual behavioral therapy (TAU). All participants will benefit from cognitive-based therapy. One group will also additionally benefit from the prior pilot-study tested mental health application. The participants could face a worsening of their general depression symptoms in this setting. In addition, similar to other forms of psychotherapy, the increase in these symptoms could trigger other symptoms of other mental illnesses. In general, because all participants will receive the usual cognitive-based therapy, risks are very low.
Where is the study run from?
Heinrich-Heine-Universität Düsseldorf Clinical Psychology (Germany)
When is the study starting and how long is it expected to run for?
September 2022 to January 2025
Who is funding the study?
Elona Health GmbH (Germany)
Who is the main contact?
Jan Kalde of the University of Duesseldorf, jan.kalde@hhu.de
Contact information
Principal Investigator
Heinrich-Heine-Universität Düsseldorf
Clinical Psychology
Universitätsstraße 1
Düsseldorf
40225
Germany
 ORCID ID |
0000-0003-1880-1861 |
|---|---|
| Phone | +49 211 81-11563 |
| jan.kalde@hhu.de |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other therapist office |
| Study type | Treatment |
| Participant information sheet | 43176 PIS.pdf |
| Scientific title | Enhancing the efficacy of CBT for patients with unipolar depression by integrating digital interventions into treatment: Results from a randomized controlled trial |
| Study hypothesis | Current study hypothesis as of 10/08/2023: Primary hypothesis (confirmatory) P1: Patients receiving bCBT with elona therapy experience stronger improvements in depression symptoms (assessed with the PHQ-9) compared to patients receiving TAU over 12 weeks of treatment. Primary safety hypotheses PS: Patients receiving bCBT with elona therapy do not experience more adverse events or serious adverse events (assessed through therapist report via eCRF, see 5.4) over the course of 12 weeks of treatment. Secondary hypotheses (exploratory) S1: Patients receiving bCBT with elona therapy experience stronger improvements in generalized anxiety symptoms (assessed with the GAD-7) compared to patients receiving TAU over 12 weeks of treatment. S2: Patients receiving bCBT with elona therapy experience stronger improvements in their psychological health-related quality of life (assessed with the psychological health subscale of the WHOQOL- BREF) compared to patients receiving TAU over 12 weeks of treatment. S3: Patients receiving bCBT with elona therapy experience stronger improvements in their depression literacy (assessed with the D-Lit) compared to patients receiving TAU over 12 weeks of treatment. S4: Patients receiving bCBT with elona therapy show higher adherence (assessed through self and psychotherapist report using a self-validated 4-item instrument) compared to patients receiving TAU over 12 weeks of treatment. S5: The proportion of patients showing clinically significant improvement (i.e., ≥ 50% symptom reduction on the PHQ-9; Israel, 2006; Keller, 2003; McMillan et al., 2010) is larger for patients receiving bCBT with elona therapy compared to patients receiving TAU over 12 weeks of treatment. S6: Patients receiving bCBT with elona therapy experience stronger improvements in their therapist-rated CGI-S scores compared to patients receiving TAU over 12 weeks of treatment. S7: Patients receiving bCBT with elona therapy experience stronger improvements in their overall symptoms compared to patients receiving TAU over 12 weeks of treatment (indicated by higher therapist-reported CGI-I scores at T1). Previous study hypothesis: Primary hypothesis (confirmatory) P1: Patients receiving bCBT with elona therapy experience stronger improvements in depression symptoms (assessed with the PHQ-9) compared to patients receiving TAU after 12 weeks of treatment. Primary safety hypotheses PS: Patients receiving bCBT with elona therapy do not experience more adverse events or serious adverse events (assessed through therapist report via eCRF, see 5.4) over the course of 12 weeks of treatment. Secondary hypotheses (exploratory) S1: Patients receiving bCBT with elona therapy experience stronger improvements in generalized anxiety symptoms (assessed with the GAD-7) compared to patients receiving TAU after 12 weeks of treatment. S2: Patients receiving bCBT with elona therapy experience stronger improvements in their psychological health-related quality of life (assessed with the psychological health subscale of the WHOQOL- BREF) compared to patients receiving TAU after 12 weeks of treatment. S3: Patients receiving bCBT with elona therapy experience stronger improvements in their depression literacy (assessed with the D-Lit) compared to patients receiving TAU after 12 weeks of treatment. S4: Patients receiving bCBT with elona therapy show higher adherence (assessed through self and psychotherapist report using a self-validated 4-item instrument) compared to patients receiving TAU after 12 weeks of treatment. S5: The proportion of patients showing clinically significant improvement (i.e., ≥ 50% symptom reduction on the PHQ-9; Israel, 2006; Keller, 2003; McMillan et al., 2010) is larger for patients receiving bCBT with elona therapy compared to patients receiving TAU after 12 weeks of treatment. S6: Patients receiving bCBT with elona therapy experience stronger improvements in their therapist-rated CGI-S scores compared to patients receiving TAU after 12 weeks of treatment. S7: Patients receiving bCBT with elona therapy experience stronger improvements in their overall symptoms compared to patients receiving TAU after 12 weeks of treatment (indicated by higher therapist-reported CGI-I scores at T1). |
| Ethics approval(s) |
Approved 05/08/2023, Ethics Committee HHU Duesseldorf (Moorenstrasse 5, Building 14.82, Dusseldorf, 40225, Germany; +49 211 81-19591; Ethikkommission@med.uni-duesseldorf.de), ref: 2022-2183-andere Forschung erstvotierend |
| Condition | Outpatient psychotherapeutic treatment of unipolar depression |
| Intervention | Current interventions as of 10/08/2023: elona therapy (Depression module) is a digital health application that supports patients in outpatient psychotherapy for unipolar depression through the delivery of therapeutic content between regular therapy sessions. With elona therapy, psychotherapists can assign interventions, helpful activities, exercises and psychoeducational resources that provide patients with information and treatment techniques related to their mental illness. Overall, over 400 different types of interventions, techniques, exercises, and psychoeducation are available beyond the regular therapy session through the elona therapy smartphone application. The content is based on current and evidence-based therapeutic methods in CBT. elona therapy allows individualizing the content to the needs of the patient. The application is designed to strengthen the active cooperation and participation of patients in outpatient psychotherapy and to integrate therapeutic content in the daily life of the patient. To test the efficacy and safety of elona therapy (Depression module), a randomized controlled trial (RCT) with patients with a clinical diagnosis of depression (including ICD-10: F32.x, F33.x, F34.1) based on ICD-10 criteria, is planned. Randomization is achieved 1:1 and stratified according to the subgroups of depression (mild/moderate/severe/dysthymia). This study follows a pilot study (https://www.isrctn.com/ISRCTN16328317). The RCT comprises two arms: Participants assigned to the treatment group will receive access to the elona therapy (Depression module) application in addition to face-to-face cognitive behavioral therapy (CBT) for 12 weeks (blended CBT; bCBT). The other group (active control group) will receive face-to-face CBT for 12 weeks (treatment as usual; TAU). The active control group will receive access to elona therapy after the study period. For evaluating the primary and secondary objectives of this study (see below) a 2 (group: bCBT, TAU) x 2 (time: pre, post) design will be used. Previous interventions: elona therapy (Depression module) is a digital health application that supports patients in outpatient psychotherapy for unipolar depression through the delivery of therapeutic content between regular therapy sessions. With elona therapy, psychotherapists can assign interventions, helpful activities, exercises and psychoeducational resources that provide patients with information and treatment techniques related to their mental illness. Overall, over 400 different types of interventions, techniques, exercises, and psychoeducation are available beyond the regular therapy session through the elona therapy smartphone application. The content is based on current and evidence-based therapeutic methods in CBT. elona therapy allows individualizing the content to the needs of the patient. The application is designed to strengthen the active cooperation and participation of patients in outpatient psychotherapy and to integrate therapeutic contents in the daily life of the patient. To test the efficacy and safety of elona therapy (Depression module), a randomized controlled trial (RCT) with patients with a clinical diagnosis of depression (including ICD-10: F32.x, F33.x, F34.1) based on ICD-10 criteria is planned. Randomization via online tool ('Climedo') The RCT comprises two arms: Participants assigned to the treatment group will receive access to the elona therapy (Depression module) application in addition to face-to-face cognitive behavioral therapy (CBT) for 12 weeks (blended CBT; bCBT). The other group (active control group) will receive face-to-face CBT for 12 weeks (treatment as usual; TAU). The active control group will receive access to elona therapy after the study period. For evaluating the primary and secondary objectives of this study (see below) a 2 (group: bCBT, TAU) x 2 (time: pre, post) design will be used. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 17/08/2023: Assessments will take place at baseline (T0) and 12 weeks after treatment start (T1): Primary efficacy objective Depressive symptoms (PHQ-9) Primary safety objective Number or seriousness of adverse events measured using patient records Previous primary outcome measure as of 10/08/2023 to 17/08/2023: Assessments will take place at baseline (T0), 6 weeks after treatment start (T1) and 10 weeks after treatment start (T2): Primary efficacy objective Depressive symptoms (PHQ-9) Primary safety objective Number or seriousness of adverse events measured using patient records Previous primary outcome measure: Assessments will take place at baseline (T0) and 12-week after treatment start (T1): Primary efficacy objective Depressive symptoms (PHQ-9) Primary safety objective Number or seriousness of adverse events measured using patient records |
| Secondary outcome measures | Assessments will take place at baseline (T0) and 12-week after treatment start (T1): 1. Generalized anxiety symptoms (measured with the GAD-7) 2. Psychological health (measured with the psychological health subscale of the WHOQOL-BREF) 3. Depression literacy (measured with the D-Lit) 4. Self efficacy (GSE) 5. Overall therapist-rated symptoms (measured with the Clinical Global Impression (CGI) Scale Item 1, CGI-S (Severity), and Item 2, CGI-I (Improvement)). 6. Adherence (assessed with a 4-item scale from the patient and therapist perspective) 7. Proportion of patients experiencing clinically significant improvements (i.e., ≥ 50% symptom reduction on the PHQ-9; Israel, 2006; Keller, 2003; McMillan et al., 2010) |
| Overall study start date | 01/09/2022 |
| Overall study end date | 31/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 324 participants (162 in each group). |
| Participant inclusion criteria | 1. All participants must have been diagnosed with one of the following ICD-10 diagnoses: F32: Depressive episode F32.0: Mild depressive episode F32.1: Moderate depressive episode F32.2: Severe depressive episode without psychotic symptoms F33: Recurrent depressive disorder F33.0: Recurrent depressive disorder, current episode mild F33.1: Recurrent depressive disorder, current episode moderate F33.2: Recurrent depressive disorder, current episode severe without psychotic symptoms F34.1: Dysthymia 2. Between the age of 18 and 65 years 3. Sufficient German language skills (in writing and reading) 4. Possess a smartphone (iOS or Android operating system) with internet access 5. Provide signed and dated informed consent, and be willing to comply with the protocol |
| Participant exclusion criteria | 1. All individuals without the included ICD-10 diagnoses 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 2. Individuals with acute suicidality (assessed via clinical assessment by the responsible therapist), 3. Individuals without any access to a smartphone (iOS or Android operating system) with internet access, and 4. Individuals with insufficient German language proficiency are excluded from this study 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. Participants will also be excluded for the respective measurement point if they fail to complete the study questionnaires within 14 days after having received them |
| Recruitment start date | 17/08/2023 |
| Recruitment end date | 31/05/2024 |
Locations
Countries of recruitment
- Germany
Study participating centres
40210 Düsseldorf, Germany
Düsseldorf
40210
Germany
50672 Köln, Germany
Köln
50672
Germany
97070 Würzburg, Germany
Würzburg
97070
Germany
44787 Bochum, Germany
Bochum
44787
Germany
01097 Dresden, Germany
Dresden
01097
Germany
09112 Chemnitz, Germany
Chemnitz
09112
Germany
50677 Köln, Germany
Köln
50677
Germany
40212 Düsseldorf, Germany
Düsseldorf
40212
Germany
Sponsor information
University/education
Heinrich-Heine-Universität Düsseldorf Clinical Psychology
Clinical Psychology
Universitätsstraße 1
40225 Düsseldorf, Germany
Düsseldorf
40225
Germany
| Phone | +49 211 81-11563 |
|---|---|
| klipsych@uni-duesseldorf.de | |
| Website | https://hhu.de |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| 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 (anonymised data) is available upon request from Jan Kalde (jan.kalde@hhu.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in German | 08/02/2023 | No | Yes |
Additional files
- 43176 PIS.pdf
- in German
Editorial Notes
17/08/2023: The following changes were made to the study record:
1. The primary outcome measure was changed to remove a timepoint and the plain English summary was updated to reflect that change.
2. The recruitment start date was changed from 14/08/2023 to 17/08/2023.
11/08/2023: Internal review.
10/08/2023: The following changes were made to the study record:
1. The ethics approval, which referred to the pilot study ISRCTN16328317 and was added in error to this study at registration, was updated accordingly.
2. The study's existence was confirmed by the ethics approval document for this study from HHU Duesseldorf provided.
3. The overall study end date was changed from 15/12/2023 to 31/01/2025 and the plain English summary was updated.
4. The study hypotheses have been updated to reflect the change in outcome measure time points.
5. The intervention field was updated to include information on randomization.
6. The primary outcome measure was updated to include a new time point.
7. The recruitment start date was changed from 13/02/2023 to 14/08/2023.
8. The recruitment end date was changed from 30/09/2023 to 31/05/2024.
9. The intention to publish date was changed from 01/07/2024 to 31/12/2024.
05/02/2023: Trial's existence confirmed by HHU Duesseldorf.
