Cognitive Dysfunction, Cognitive Impairment, Depression, Depressive Disorder
Conditions
Brief summary
Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.
Interventions
BEHAVIORALde:)press
Patients will receive de:)press for the duration of six weeks. They will be encourages to use the app at least three times a week, up to once per day.
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male, female, diverse, * age \>= 18, * informed consent, * sufficient understanding of German (native speaker or CEFR level B skills or higher), * unipolar depression diagnosed according to ICD-10 (F32.0, F32.1, F32.2 or F33. 0, F32.1, F32.2). * consultation with a physician due to depressive symptomatology within the last 6 months
Exclusion criteria
* Inability to give consent, * inability to use de:)press® on a tablet or smartphone, * acute suicidality, * schizophrenia (F20), * brief psychotic disorder (F23), * schizoaffective disorder (F25), * mental disorders due to known physiological conditions (F00 - F09), * major depressive disorder, single episode, severe with psychotic features (F32.3), * major depressive disorder, recurrent, severe with psychotic features (F33.3), * Intellectual disability (F70 - F79).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS | 10 weeks | Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate | 10 weeks | MADRS score ≤ 10. |
| IDS-SR reduction | 10 weeks | Reduction (IG vs. CG) of IDS-SR score during treatment phase and at final examination. |
| WHO-5 changes | 10 weeks | Changes of well-being according to WHO-5 during treatment period and at final examination. |
| Response rate | 10 weeks | Response rate (MADRS ≤ 50%) at the final examination. |
| Training sessions | 6 weeks | Number of completed training sessions in IG. |
| Adverse events | 10 weeks | Adverse events. |
| Self-esteem | 10 weeks | Influence of RSES on the primary endpoint. |
| WPAI changes | 10 weeks | Changes of functionality according to WPAI during treatment period and at final examination. |
Countries
Germany
Contacts
Primary ContactSimone Weller, M.Sc.
Outcome results
None listed