Psychotherapy and Cardiovascular Risk Factors in Depression
The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.
The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Marburg, Allemagne, 35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients with Major Depression (DSM IV), BDI >=14
- age:18-65 years
- patients without antidepressive medication (stable for at least 2 weeks)
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
Exclusion Criteria:
- current psychotherapy
- psychotic disorder
- serious drug-addiction
- drugs which seriously affect immune status (except contraceptives) or central
- nervous system functions (except antidepressants)
- infections during the last 2 weeks
- injuries during the last 2 weeks
- neurological disorders
- diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Cognitive behavioral therapy
Cognitive behavioral therapy for Major Depression
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Aucune intervention: Waitlist group
Waitlist group to control for repeated physiological measures and fluctuations over time
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in depressive symptoms (BDI-II)
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in heart rate variability
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
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Change in blood pressure
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
|
Change in baroreceptor sensitivity (ms/mmHg)
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
|
Change in peripheral vascular resistance (dyne*s/cm5)
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
|
Change in C-reactive protein
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
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Change in proinflammatory cytokines
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
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Change in anti-inflammatory interleukin-10
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
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Change in Subjective social status (MacArthur scale)
Délai: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Frank Euteneuer, PhD, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DFG EU 154 2 1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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