Pilot study to test a digital health program for the blended therapy of unipolar depression and anxiety disorder in adults

Not Applicable

Completed

• Conditions: nipolar depression and anxiety disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN16328317
• Lead Sponsor: Heinrich Heine University Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-26
• Study Completion: 2022-09-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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
F32.8: Other depressive episodes
F32.9: Depressive episode, unspecified

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
F33.8: Other recurrent depressive disorders
F33.9: Recurrent depressive disorder, unspecified

F34: Persistent mood [affective] disorders
F34.0: Cyclothymia
F34.1: Dysthymia
F34.8: Other persistent mood [affective] disorders
F34.9: Persistent mood [affective] disorder, unspecified

F40.0 Agoraphobia
F40.00 Agoraphobia without panic disorder
F40.01 Agoraphobia with panic disorder
F40.1 Social phobias
F40.2 Specific (isolated) phobias
F40.8 Other phobic anxiety disorders
F40.9 Phobic anxiety disorder, unspecified

F41.0 Panic disorder [episodic paroxysmal anxiety]
F41.1 Generalized anxiety disorder
F41.2 Mixed anxiety and depressive disorder
F41.3 Other mixed anxiety disorders
F41.8 Other specified anxiety disorders
F41.9 Anxiety disorder, unspecified

F45.2 Hypochondriacal disorder

2. Participants need to be between the age of 18 and 65 years
3. Participants need to possess sufficient German language skills (in writing and reading)
4. Participants need to possess a smartphone (iOS or Android operating system) with internet access
5. Participants need to provide signed and dated informed consent and are willing to comply with the protocol

Exclusion Criteria

1. All participants without the inclusion ICD-10 diagnosis criteria as well as participants with the following 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
If a participant 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Group 1 (patients with depression):<br>Depression symptoms measured using the 5-point (Likert Scale) BDI-II online questionnaire at the beginning of the treatment and after 6 and 12 weeks<br><br>Group 2 (patients with anxiety):<br>Anxiety symptoms measured using the 5-point (Likert Scale) BAI online questionnaire at the beginning of the treatment and after 6 and 12 weeks