- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07853989
Effect of TMS Treatment on Defense Mechanisms and Functionality in Patients With Depression
The Effect of Transcranial Magnetic Stimulation (TMS) Treatment on Defense Mechanisms and Functionality in Patients With Depression
This prospective observational study aims to evaluate changes in psychological defense mechanisms in patients with non-psychotic major depressive disorder (MDD) undergoing repetitive Transcranial Magnetic Stimulation (rTMS) therapy. The study investigates whether rTMS induces a shift from immature to more mature defense mechanisms and assesses how these changes relate to improvements in depressive symptom severity, anxiety levels, and overall functionality at baseline, 1-month, and 3-month follow-ups.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Major depressive disorder (MDD) significantly impacts mood, cognitive function, and psychological defense structures. While repetitive Transcranial Magnetic Stimulation (rTMS) is an established non-invasive neuromodulation therapy for depression, its influence on psychodynamic constructs such as defense mechanisms remains insufficiently explored.
This single-center prospective study will enroll 50 adult participants (aged 18-65) diagnosed with non-psychotic MDD according to DSM-5 criteria (confirmed via SCID-5). Participants will receive rTMS treatment as part of their standard clinical care. Clinical assessments will be conducted by a blinded researcher at three time points: baseline (pre-treatment), 1 month, and 3 months post-baseline.
Primary outcomes will measure shifts in defense mechanism styles (mature, neurotic, immature) using the Defense Style Questionnaire (DSQ). Secondary outcomes will assess depressive symptom severity (Hamilton Depression Rating Scale - HAM-D), anxiety levels (Hamilton Anxiety Rating Scale - HAM-A), clinical severity and improvement (Clinical Global Impression Scale - CGI), and functional impairment (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0).
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Kardelen Erdoğan, MD
- Telefonnummer: +90 543 691 87 52
- E-Mail: kardelenerdogan@nku.edu.tr
Studienorte
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Tekirdağ, Türkei (türkiye)
- Tekirdağ Namik Kemal University Faculty of Medicine, Department of Psychiatry
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Kontakt:
- kardeeln erdoğan, MD
- Telefonnummer: +90 543 691 87 52
- E-Mail: kardelenerdogan@nku.edu.tr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adults aged 18-65 years with non-psychotic major depressive disorder (MDD) who are evaluated for suitability for transcranial magnetic stimulation (TMS) treatment at the Psychiatry Clinic/TMS Unit of Tekirdağ Namık Kemal University Hospital. The diagnosis of MDD will be confirmed using the Structured Clinical Interview for DSM Disorders (SCID). Approximately 50 participants who meet the eligibility criteria and provide written informed consent will be included.
Beschreibung
Inclusion Criteria:
- Age between 18 and 65 years
- Diagnosis of major depressive disorder without psychotic features according to DSM-5 criteria
- Confirmation of diagnosis via SCID
- Major depressive disorder as the primary reason for admission
- Willingness to participate and signing the written informed consent form
Exclusion Criteria:
- Presence of contraindications for TMS (e.g., metallic implants)
- Known active psychotic symptoms
- History of TMS treatment in the past 3 months
- Presence of known organic brain syndrome, neurological, or major systemic medical conditions
- Presence of known intellectual disability or significant cognitive impairment
- Active substance or alcohol use disorder
- Illiteracy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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TMS Treatment Group
Patients diagnosed with major depressive disorder receiving Transcranial Magnetic Stimulation therapy. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Defense Mechanisms (Defense Style Questionnaire - DSQ)
Zeitfenster: Baseline, 1 month, and 3 months
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Evaluates shifts in mature, neurotic, and immature psychological defense mechanism styles in patients with major depressive disorder following TMS treatment. |
Baseline, 1 month, and 3 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Anxiety Symptom Severity (Hamilton Anxiety Rating Scale - HAM-A)
Zeitfenster: Baseline, 1 month and 3 months
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Assesses psychic and somatic anxiety symptom severity. |
Baseline, 1 month and 3 months
|
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Change in Depressive Symptom Severity (Hamilton Depression Rating Scale - HAM-D)
Zeitfenster: Baseline, 1 month, and 3 months
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Assesses the severity of depressive symptoms |
Baseline, 1 month, and 3 months
|
|
Change in Clinical Global Impression (CGI)
Zeitfenster: Baseline, 1 month, and 3 months
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Measures overall illness severity and clinical improvement. |
Baseline, 1 month, and 3 months
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Change in Disability and Functionality (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
Zeitfenster: Baseline, 1 month, and 3 months
|
Evaluates level of functional disability across six domains (understanding/communicating, mobility, self-care, getting along, life activities, participation). |
Baseline, 1 month, and 3 months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026.197.07.01
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