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App against Depression - Efficacy of a guided smartphone self-management app for mild to moderate depression.

Organizational Data

DRKS-ID:
DRKS00031388
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-03-02
Last update in DRKS:
2024-04-02
Registration type:
Prospective

Acronym/abbreviation of the study

App against Depression

URL of the study

No Entry

Brief summary in lay language

The study, App against Depression, will investigate the efficacy of the online self-management app, "iFightDepression App" for mild to moderate depression. The iFightDepression app includes six workshops based on cognitive behavioral therapy. In the workshops, participants receive information on different aspects of the disease and are guided to perform exercises and document them within the app. The potential study participants are patients who have been diagnosed with a depressive disorder and are currently receiving outpatient treatment. The study participants will be required to use the iFightDepression app for eight weeks, alongside their usual treatment. The effect of the app will be compared to a control group receiving only treatment-as-usual (TAU). The effect of the app on symptoms will be assessed through regular telephone interviews and online questionnaires (before, during and after the program). We expect depressive symptoms to be significantly lower after 8 weeks of intervention than in the TAU control group. In order to investigate whether changes are also stable long term, we conduct additional surveys three months after the end of the program. The survey consists of a telephone interview and self-report questionnaires.

Brief summary in scientific language

Depressive symptoms are very prevalent among primary care patients and are often not adequately treated due to e.g. long waiting times. Evidence-based treatment options need to be developed and implemented for this large group of patients in order to close the gaps between single outpatient and inpatient treatment options. E-health applications can be an effective way to contribute to a remission of depressive symptoms. Therefore, the App against Depression study will investigate the efficacy of the iFightDepression app for mild to moderate depression. The iFightDepression app includes six workshops based on cognitive behavioral therapy. In the workshops, participants receive information on different aspects of the disease and are guided to perform exercises and document them within the app. The potential study participants are patients who have been diagnosed with a depressive disorder and are currently receiving outpatient treatment. The study participants will be required to use the iFightDepression app for eight weeks, alongside their usual treatment. The effect of the app will be compared to a control group receiving only treatment-as-usual (TAU). The effect of the app on symptoms will be assessed through regular telephone interviews and online questionnaires (before, during and after the program). We expect depressive symptoms to be significantly lower after 8 weeks of intervention than in the TAU control group. In order to investigate whether changes are also stable long term, we conduct additional surveys three months after the end of the program. The survey consists of a telephone interview and self-report questionnaires.

Health condition or problem studied

ICD10:
F34.1 - Dysthymia
ICD10:
F32.0 - Mild depressive episode
ICD10:
F32.1 - Moderate depressive episode
ICD10:
F33.0 - Recurrent depressive disorder, current episode mild
ICD10:
F33.1 - Recurrent depressive disorder, current episode moderate
ICD10:
F32.9 - Depressive episode, unspecified
ICD10:
F33.9 - Recurrent depressive disorder, unspecified
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Arm 1 - Usage of iFightDepression app (self-management programme), 8 weeks. The iFightDepression app includes workshops on the following topics: "Thinking, feeling and doing", "Sleep and depression", "Planning and doing things you enjoy", "Getting things done", "Recognizing negative thoughts" and "Changing negative thoughts". In each workshop, videos illustrate information and provide exercises that can be applied in everyday life. Interactive elements of the app support the implementation of the exercises and regularly remind participants to use the app. The participants remain in treatment and are guided in the use of the app by their doctor or psychological psychotherapist.
Arm 2:
Arm 2 - TAU (Treatment as usual), 8 weeks Patients in the TAU group receive antidepressants and/or psychotherapy or are initially observed further in the context of active-waiting observation ("watchfull waiting").

Endpoints

Primary outcome:
The primary outcome of the current study is the improvement of depressive symptoms through participation in an internet-based self-management app in adults with mild to moderate depression compared to a TAU control group (treatment as usual). The primary outcome measure is the German version of the "Inventory of Depressive Symptomatology - Self Report" (IDS-SR) after the end of the 8-week intervention.
Secondary outcome:
Secondary outcome are changes in quality of life (SF-12) and improvement of depressive symptoms (IDS-SR) compared to the TAU control group 3 months after the end of the intervention. An exploratory analysis of patient satisfaction (ZUF-8/CSQ-8) as well as the usage of outpatient care services will be conducted and both results will be compared to those found in the literature. The frequency of logins, number of entries and completed workshops (as objective measures) as well as the amount of guidance (according to self-report) will be reported descriptively.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
The person who decides on the inclusion of the participants in the study does not know at the time which group they will belong to. The allocation to the group is carried out by the study management programme "Castor EDC" after inclusion.
Blinding:
No
Assignment:
Parallel
Sequence generation:
1:1 randomisation into the intervention + TAU group and the TAU group (treatment-as-usual) stratified for screening score on the PHQ-9 (current depression severity) with two levels (severe and moderate, cut-off at sum score of 14) and the professional group of the guide to the intervention with 3 levels (psychotherapist, specialist or GP).
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Universitätsklinikum Klinik für Psychiatrie, Psychosomatik und Psychotherapie Frankfurt am Main

Recruitment period and number of participants

Planned study start date:
2024-05-15
Actual study start date:
No Entry
Planned study completion date:
2024-10-31
Actual Study Completion Date:
No Entry
Target Sample Size:
234
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
-Mild to moderate depressive episode in the context of a unipolar depressive episode (ICD-10 F32.0; F32.1, F32.9) or a recurrent unipolar depressive disorder (ICD-10: F33.0, F33.1, F33.9) or a dysthymia - Outpatient status - Respondent is able to communicate both verbally and in writing, German-speaking - Internet-enabled smartphone to download and use the intervention (iFightDepression app) - Written informed consent - PHQ-9 score 5-19

Exclusion Criteria

ICD-10 diagnoses: dementia, alcohol dependence, drug dependence, schizophrenia, mania and bipolar disorder, obsessive-compulsive disorder (F0, F1, F2, F30, F31, F42), personality disorder (F60.2, F60. 31), Known alcohol or drug abuse within the last 6 months based on information from the treating physician/therapist. Acute suicidality (according to item 9 PHQ and physician). Physical illness requiring immediate (partial) inpatient treatment. Participation in another clinical trial within the last 4 weeks. Pregnancy

Addresses

Primary Sponsor

Stiftung Deutsche Depressionshilfe
Goerdelerring 9
04109 Leipzig
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Stiftung Deutsche Depressionshilfe Forschungszentrum
Prof. Dr. Ulrich Hegerl
Heinrich-Hoffmann-Str. 10
60528 Frankfurt am Main
Germany
Telephone:
+49 341 22387420
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Stiftung Deutsche Depressionshilfe Forschungszentrum
M.Sc. Psych Katharina Scholze
Goerdelerring 9
04109 Leipzig
Germany
Telephone:
+49 341 22387420
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Stiftung Deutsche Depressionshilfe Forschungszentrum
Prof. Dr. Ulrich Hegerl
Heinrich-Hoffmann-Str. 10
60528 Frankfurt am Main
Germany
Telephone:
+49 341 22387420
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Stiftung Deutsche Depressionshilfe
Goerdelerring 9
04109 Leipzig
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o Universitätsklinikum
Theodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-211
60590 Frankfurt/Main
Germany
Telephone:
+49-69-63017239
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-09-14
Ethics committee number:
2021-419
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-12-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
DRKS00009301 - Pilotstudie

Publication of study results

Planned publication:
01.07.2024
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry