Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07488910 (DYNDET) for Depression - Major Depressive Disorder is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
Goethe UniversityDynamic Networks in Depression Treatment: Mechanisms of Change in Pharmacological, Psychological and Combined Treatment of Depression (DYNDET) Phase 4 90
Clinical Trial NCT07488910 (DYNDET) is designed to study Treatment for Depression - Major Depressive Disorder. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 February 2026 until the study accrues 90 participants. Led by Goethe University, this study is expected to complete by 1 January 2028. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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 an...
Show MoreOfficial Title
Veränderungen Dynamischer Symptom-Netzwerke Unter Pharmakologischer, Psychotherapeutischer Und Kombinierter Behandlung Bei Depression (DYNDET)
Conditions
Depression - Major Depressive DisorderOther Study IDs
- DYNDET
- 2025-2718
NCT ID Number
Start Date (Actual)
2026-02
Last Update Posted
2026-03-23
Completion Date (Estimated)
2028-01
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPsychopharmacological treatment Participants receive psychopharmacological treatment according to guideline-based clinical practice. | Psychopharmacological treatment 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. |
ExperimentalPsychotherapeutical group treatment Participants receive manualized cognitive-behavioral group psychotherapy. | Cognitive-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. |
ExperimentalCombined intervention Combination of the aforementioned psychopharmacological and cognitive-behavioral group treatment. | Psychopharmacological treatment 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. Cognitive-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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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) |
| Outcome Measure | 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) | 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Depressive disorder (mild to moderate symptom severity)
- 18-65 years
- must own a smartphone with internet access
- severe depressive episode
- acute suicidality,
- bipolar disorder,
- substance use disorder
- psychotic depression
- severe medical or neurological illness
- insufficient german language skills
- concurrent psychotherapeutic treatment
- conditions that may interfere with fMRI
Goethe University38 active studies to explore- Johann Wolfgang Goethe University Hospital
- Philipps University Marburg
Study Responsible Party
Prof. Dr. Ulrich Stangier, Principal Investigator, Goethe Research Professorship, Goethe University
No contact data.
3 Study Locations in 1 Countries
Clinical Psychology and Psychotherapy, Frankfurt, 60486, Germany
Ulrich Stangier, Prof. Dr., Contact, +496979823842, [email protected]
Mareike Ebert, M.Sc., Contact, [email protected]
Department of Psychiatry, Psychosomatics and Psychotherapy, Frankfurt, 60528, Germany
Oliver Grimm, PD Dr., Contact, +6906963012224, [email protected]
Department of Psychiatry and Psychotherapy, Marburg, 35039, Germany
Igor Nenadić, Prof. Dr., Contact, +4964215865002, [email protected]