- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Kardelen Erdoğan, MD
- Telefonnummer: +90 543 691 87 52
- E-post: kardelenerdogan@nku.edu.tr
Studieorter
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-
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Tekirdağ, Turkiet (Türkiye)
- Tekirdağ Namik Kemal University Faculty of Medicine, Department of Psychiatry
-
Kontakt:
- kardeeln erdoğan, MD
- Telefonnummer: +90 543 691 87 52
- E-post: kardelenerdogan@nku.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
TMS Treatment Group
Patients diagnosed with major depressive disorder receiving Transcranial Magnetic Stimulation therapy. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Defense Mechanisms (Defense Style Questionnaire - DSQ)
Tidsram: Baseline, 1 month, and 3 months
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Anxiety Symptom Severity (Hamilton Anxiety Rating Scale - HAM-A)
Tidsram: Baseline, 1 month and 3 months
|
Assesses psychic and somatic anxiety symptom severity. |
Baseline, 1 month and 3 months
|
|
Change in Depressive Symptom Severity (Hamilton Depression Rating Scale - HAM-D)
Tidsram: Baseline, 1 month, and 3 months
|
Assesses the severity of depressive symptoms |
Baseline, 1 month, and 3 months
|
|
Change in Clinical Global Impression (CGI)
Tidsram: Baseline, 1 month, and 3 months
|
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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026.197.07.01
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