About this trial
This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Using intensive longitudinal ecological momentary assessment data, the trial examines treatment-specific changes in symptom interactions.
By applying network-based analytic approaches, the study aims to elucidate differential and potentially complementary mechanisms of change across treatment modalities. Findings may contribute to more informed and individualized treatment strategies for major depressive disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Depressive disorder (mild to moderate symptom severity)
18-65 years
must own a smartphone with internet access
Disqualifiers
severe depressive episode
acute suicidality,
bipolar disorder,
substance use disorder
Trial design
Parallel
Treatments tested in this trial
Psychopharmacological treatment
DrugParticipants will receive outpatient treatment with escitalopram. Treatment will be initiated at 5 mg/day for three days and increased to a target dose of 10 mg/day. Clinical re-evaluations will take place after two and four weeks. In case of insufficient clinical response, the dose may be increased to 15 mg/day in accordance with guideline recommendations.
Cognitive-behavioral group treatment (CBGT-D)
BehavioralConsisting of a group treatment of the same time frame as the psychopharmacological treatment and includes the following components: psychoeducation, behavioral activation, cognitive restructuring, social problem-solving, homework assignments and relapse prevention.
Treatment groups
Trial outcomes
Primary outcomes
Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR)
Planned network intervention analyses will focus on intervention-specific effects at the symptom-network level. We will describe whether each of the three interventions shows differential direct associations with specific depressive symptoms or processes, operationalized as edges between intervention indicators and symptom/process nodes. We will also examine whether the interventions differ in their pattern of indirect associations within the network, that is, whether changes in some symptoms appear to be associated with downstream changes in other symptoms or processes. In addition, we will compare centrality metrics of depressive symptoms across interventions and over time.
Secondary outcomes
Hamilton rating scale for depression (HAM-D)
Observer rated scale of depression severity. Total score ranging from 0 to 51, with lower scores indicating less severity of depressive symptoms.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Observer rated scale of depression severity. Total score ranging from 0 to 60, with lower scores representing less severity of depressive symptoms.
The Inventory of Depressive Symptomatology clinician (IDS-C)
Observer rated scale of depression severity. Total score ranging from 0 to 84, with lower scores indicating less severity of depressive symptoms.
Social and Occupational Functioning Assessment Scale (SOFAS)
Observer rated scale of social and functional impairment. Scores ranging from 0 to 100, with higher scores representing a higher level of functioning.
Sponsors and contacts
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Goethe University
Lead sponsor
Johann Wolfgang Goethe University Hospital
Collaborator
Philipps University Marburg
Collaborator
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