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| Name | Class |
|---|---|
| Johann Wolfgang Goethe University Hospital | OTHER |
| Philipps University Marburg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychopharmacological treatment | Experimental | Participants receive psychopharmacological treatment according to guideline-based clinical practice. |
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| Psychotherapeutical group treatment | Experimental | Participants receive manualized cognitive-behavioral group psychotherapy. |
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| Combined intervention | Experimental | Combination of the aforementioned psychopharmacological and cognitive-behavioral group treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychopharmacological treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline (2 weeks) to immediately Post-Treatment (11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Inclusion to immediately Post-Treatment (11 weeks) |
| Montgomery-Åsberg Depression Rating Scale (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Nenadic, Prof. Dr. | Philipps University Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Psychology and Psychotherapy | Frankfurt | 60486 | Germany |
Individual participant data that underlie reported results will be shared after deidentification.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2026 | Mar 18, 2026 |
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The study employs a parallel-group design with three arms: selective serotonin reuptake inhibitor (SSRI) pharmacotherapy, cognitive behavioral therapy (CBT) delivered in a group format, and a combination of both interventions. The study is multicentred across two locations encompassing three study centres.
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Due to the nature of the interventions, full blinding is not feasible. Participants are aware of their assigned treatment condition, as the interventions differ in format (e.g., pharmacotherapy versus group CBT). Similarly, therapists and prescribing physicians are not blinded. However, clinical outcome assessments, specifically structured interviews such as the HAM-D, are conducted by trained raters who remain blinded to group allocation wherever possible. To reduce analytical bias, data analysis will be conducted on pseudonymized datasets, with group identifiers masked during preprocessing and statistical modeling stages (Schulz et al., 2010).
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| Cognitive-behavioral group treatment (CBGT-D) | Behavioral | 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. |
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Observer rated scale of depression severity. Total score ranging from 0 to 60, with lower scores representing less severity of depressive symptoms. |
| 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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. | From Inclusion to immediately Mid-Treatment (7 weeks) |
| Department of Psychiatry, Psychosomatics and Psychotherapy | Frankfurt | 60528 | Germany |
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| Department of Psychiatry and Psychotherapy | Marburg | 35039 | Germany |
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| Prot_000.pdf |