Improving the effectiveness of cognitive based therapy for depression with digital interventions: findings from a randomized control trial

Not Applicable

• Conditions: Outpatient psychotherapeutic treatment of unipolar depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN11129335
• Lead Sponsor: Heinrich-Heine-Universität Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 28 August 2023
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 324

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified