NCT Number: NCT07488910
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 4
Clinical Psychology and Psychotherapy, Frankfurt, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Self-report scale of social support. A higher score indicates a better outcome.
Time frame: 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.
Time frame: 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.
Goethe University
Other
Veränderungen Dynamischer Symptom-Netzwerke Unter Pharmakologischer, Psychotherapeutischer Und Kombinierter Behandlung Bei Depression (DYNDET)
Acronym: DYNDET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738146
Behavior, Behavioral Symptoms
Astana, Kazakhstan
View Trial DetailsNCT07553364
Behavior, Behavioral Symptoms
Winston-Salem, North Carolina, United States
View Trial DetailsNCT07684521
Anxiety, Anxiety Disorders
Los Angeles, California, United States
View Trial DetailsNCT07680140
Depression - Major Depressive Disorder, Depressive Disorder
New York, United States
View Trial Details