Late-Life Treatment Resistant Depression Difficult-to-treat depression in the elderly
Conditions
Interventions
Behavioural Activation (BA)BA will be provided in the active condition, complementing rTMS treatment with intervention aimed at alleviating depressive symptoms through structured, goal-oriented activi
BA is designed to increase engagement with positively reinforcing activities and reduce avoidance behaviors that perpetuate depressive states (Crits-Christoph et al., 2021). Sessions will focus on ide
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Older adults (aged =60) with moderate to severe, non-psychotic, unipolar depression, with inadequate response to =2 adequate trials.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they have a lifetime diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, or a current addiction disorder, exhibit psychotic features, or have severe cognitive impairment (MOCA score < 15).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the study is absolute change of depressive symptoms after 8 weeks of treatment assessed by change in MADRS score from baseline, with repeated measures performed after sessions 8, 16, 24, and 30. The study is considered successful if there is a clinically meaningful improvement in depressive symptoms, defined as a 50% reduction in the MADRS score from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are:Cost-effectiveness of rTMS + BA versus rTMS alone: Health care usage/costs (TicP) and other costs (such as informal care or productivity losses due to absenteeism/presenteeism if applicable in the LLD group)Response (50% symptom reduction) Remission (sum score MADRS<10) Clinician-rated change in depressive symptom severity, assessed by change in MADRS score over time during follow-upChange in anhedonia (as measured with the SHAPS) and other depression-related symptoms (IDS-Self Report) to align also with an ongoing ZONMW trial on BAChange in apathy (SAS) and cognitive functioning ( MOCA)Quality-adjusted life years based on the EQ-5D-5L.Behavioral activation (BADS-SF)Recurrence of depressive symptoms, assessed by change in remitter status between end of treatment and follow-up measures Safety assessed by adverse eventsAcceptability assessed by questions based on TFA acceptability questionnaire | — |
Countries
Netherlands
Contacts
Public ContactI. Tendolkar
Radboud Universitair Medisch Centrum
Outcome results
None listed