A Phase 4 interventional study of Psychopharmacological treatment and Cognitive-behavioral group treatment (CBGT-D) in Depression - Major Depressive Disorder, sponsored by Goethe University. Not yet recruiting at 3 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Goethe University · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Participants receive psychopharmacological treatment according to guideline-based clinical practice.
Drug: Psychopharmacological treatment
Participants receive manualized cognitive-behavioral group psychotherapy.
Behavioral: Cognitive-behavioral group treatment (CBGT-D)
Combination of the aforementioned psychopharmacological and cognitive-behavioral group treatment.
Drug: Psychopharmacological treatment · Behavioral: Cognitive-behavioral group treatment (CBGT-D)
Participants 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.
Consisting 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.
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.
Time frame: From Baseline (2 weeks) to immediately Post-Treatment (11 weeks)
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.
Time frame: From Inclusion to immediately Post-Treatment (11 weeks)
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.
Time frame: From Inclusion to immediately Post-Treatment (11 weeks)
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.
Time frame: From Inclusion to immediately Post-Treatment (11 weeks)
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.
Time frame: Immediately at Inclusion
Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Self report scale of positive and negative affect. Scores can range from 10 to 50 for both subscales (positive affect and negative affect). Higher scores indicate a higher level of either positive or negative affect
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Perseverative Thinking Questionnaire (PTQ)
Self-rating scale for repetitive negative thinking. The score ranges from 0 to 60. Higher scores indicate a higher level of repetitive negative thinking
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
The Acceptance and Action Questionnaire (AAQ-2)
Self-rated measure of psychological flexibility. Score ranging from 7 to 49. Higher total scores indicate less flexibility, while lower total scores indicate more flexibility.
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Fragebogen zur sozialen Unterstützung (F-SozU)
Self-report scale of social support. A higher score indicates a better outcome.
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Couples Satisafction Index (CSI-4)
Self-report scale of relationship satisfaction in couples with a score range from 0 to 21. Higher scores are associated with higher levels of relationship satisfaction.
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Perceived Deficits Questionnaire - Depression (PDQ-D)
Self-rating scale of cognitive dysfunction. Score ranging from 0 to 80. Higher scores representing higher cognitive dysfunction.
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Individual participant data that underlie reported results will be shared after deidentification.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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