Depression - Major Depressive Disorder
Conditions
Brief summary
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.
Interventions
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.
BEHAVIORALCognitive-behavioral group treatment (CBGT-D)
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.
Sponsors
Goethe University
Johann Wolfgang Goethe University Hospital
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Depressive disorder (mild to moderate symptom severity) 2. 18-65 years 3. must own a smartphone with internet access
Exclusion criteria
1. severe depressive episode 2. acute suicidality, 3. bipolar disorder, 4. substance use disorder 5. psychotic depression 6. severe medical or neurological illness 7. insufficient german language skills 8. concurrent psychotherapeutic treatment 9. conditions that may interfere with fMRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR) | From Baseline (2 weeks) to immediately Post-Treatment (11 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Hamilton rating scale for depression (HAM-D) | From Inclusion to immediately Post-Treatment (11 weeks) | 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) | From Inclusion to immediately Post-Treatment (11 weeks) | 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) | From Inclusion to immediately Post-Treatment (11 weeks) | 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) | Immediately at Inclusion | Observer rated scale of social and functional impairment. Scores ranging from 0 to 100, with higher scores representing a higher level of functioning. |
| Positive and Negative Affect Schedule - Short Form (PANAS-SF) | From Inclusion to immediately Mid-Treatment (7 weeks) | 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 |
| Perseverative Thinking Questionnaire (PTQ) | From Inclusion to immediately Mid-Treatment (7 weeks) | Self-rating scale for repetitive negative thinking. The score ranges from 0 to 60. Higher scores indicate a higher level of repetitive negative thinking |
| The Acceptance and Action Questionnaire (AAQ-2) | From Inclusion to immediately Mid-Treatment (7 weeks) | 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. |
| Fragebogen zur sozialen Unterstützung (F-SozU) | From Inclusion to immediately Mid-Treatment (7 weeks) | Self-report scale of social support. A higher score indicates a better outcome. |
| Couples Satisafction Index (CSI-4) | From Inclusion to immediately Mid-Treatment (7 weeks) | 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. |
| Perceived Deficits Questionnaire - Depression (PDQ-D) | From Inclusion to immediately Mid-Treatment (7 weeks) | Self-rating scale of cognitive dysfunction. Score ranging from 0 to 80. Higher scores representing higher cognitive dysfunction. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORIgor Nenadic, Prof. Dr.
Philipps University Marburg
Outcome results
None listed