OBJECTIVE(S)/RESEARCH QUESTION(S) What is the cost-effectiveness of a cognitive control training (CCT) as an add-on intervention in elderly depressed patients (EDP)?
HYPOTHESIS CCT is superior to placebo training in reducing depressive symptoms in EDP. As seen from a probabilistic and medical decision-making point of view, CCT will be more cost-effective than usual care alone both from a health care and societal perspective.
STUDY DESIGN A randomized controlled trial with two arms, in patients receiving treatment as usual (TAU).
STUDY POPULATION(S)/DATASETS 104 EDP (>= 60 y.) who attend outpatient care for old-age psychiatry.
INTERVENTION CCT is an individually tailored training scheme to improve cognitive control.
USUAL CARE /COMPARISON TAU is the standard care delivered in old-age psychiatry. CCT is compared to an active placebo training that does not train cognitive control.
OUTCOME MEASURES IDS depressive symptom severity, rumination, neurocognitive processing (working memory), EQ-5D-5L health-related quality of life.
SAMPLE SIZE CALCULATION/DATA ANALYSIS To detect a medium effect size of d=0.45 (or larger) at a=0.05 (2-tailed) and a power of (1-b)=0.80 the required sample size should be n=104 at baseline. All analyses will adhere to the intention to treat principle using (generalised) linear mixed-models.
COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS The health-economic evaluation will be conducted alongside the trial and encompass a CEA, CUA and BIA as per the pertinent guidelines.
TIME SCHEDULE The project will start 1.12.2018 and will run for 48 months.