Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- MADRS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 F
- •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).
Arms & Interventions
Control
Control group that will receive the app after primary endpoint was assessed.
Intervention
Experimental group that will receive the app at the start of their participation
Intervention: de:)press (Behavioral)
Outcomes
Primary Outcomes
MADRS
Time Frame: 10 weeks
Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination.
Secondary Outcomes
- Training sessions(6 weeks)
- Response rate(10 weeks)
- IDS-SR reduction(10 weeks)
- WHO-5 changes(10 weeks)
- Remission rate(10 weeks)
- Self-esteem(10 weeks)
- WPAI changes(10 weeks)
- Adverse events(10 weeks)