Confirmed diagnosis of unipolar major depression according to ICD-10, single or recurrent episode (F32.0, F32.1, F32.2, F33.0, F33.1, F33.2) as the primary clinical condition.
Conditions
Interventions
Group 1: The intervention group (intention-to-treat, ITT) receives a six-week app-based cognitive control training (CCT) using de:)press® as an add-on to treatment-as-usual (TAU), constituting a blend
primary endpoint).
Group 2: The control group (CG) receives guideline-based treatment as usual (TAU) following study inclusion and baseline assessment (T0). All assessments are repeated at six weeks (
Sponsors
Universität Leipzig, Medizinische Fakultät, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible participants are adults with a confirmed diagnosis of unipolar major depression (ICD-10 codes F32.0, F32.1, F32.2, F33.0, F33.1, F33.2) as the primary clinical condition. Requirements include signed informed consent, sufficient German language proficiency, and the ability and experience to use a mobile device for the intervention app.
Exclusion criteria
Exclusion criteria: Participants are excluded in cases of lacking consent capacity, acute suicidality, severe major depression with psychotic features (F32.3, F33.3), mental disorders due to known physiological causes (F00–F09), schizophrenia spectrum and other psychotic disorders (F20, F22, F23, F25), bipolar and related disorders (F30, F31, F34.0), primary alcohol or substance dependence (F1x.2; exception F17.2), intellectual disabilities (F70–F79), somatic or neurological comorbidities affecting cognitive performance, current use of other cognitive control training (CCT) interventions, legal guardianship or institutionalization, and lack of compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score on the Hamilton Depression Rating Scale (HAMD-21) at the final study visit four weeks after the end of the intervention (T2), assessing the severity of depressive symptoms and allowing for between-group comparisons. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include: (a) Response and remission rates, based on the total score of the HAMD-21 at the final study visit. (b) Changes in subjectively perceived depressive symptoms, measured by the BDI-II total score at the end of the intervention and at the final study visit. (c) Changes in general well-being, assessed using the WHO-5 at the end of the intervention and at the final study visit. (d) Changes in cognitive functioning (objective and subjective), measured via the app-based THINC-it neuropsychological test battery at the end of the intervention and at the final study visit. (e) Changes in trait and state rumination tendencies, assessed by the total score of the Rumination subscale of the Rumination-Reflection Questionnaire (RRQ) and an adapted version of the Perseverative Thinking Questionnaire (PTQ), at the end of the intervention and at the final study visit. (f) Influence of treatment expectation, operationalized by an adapted version of the “General Treatment Expectation” subscale of the Therapy Motivation Questionnaire (FMP), assessed before the intervention. (g) Influence of participant motivation, measured by the number of completed training sessions in the intervention group. (h) Treatment satisfaction, assessed by the total score of an adapted version of the ZUF-8 questionnaire at the end of the intervention. (i) Feasibility of implementation into inpatient care, evaluated through usage rates and documentation of reasons for non-usage | — |
Countries
Germany
Contacts
Public ContactMaria Strauß
Universität Leipzig, Medizinische Fakultät, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Outcome results
None listed