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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Marburg, Duitsland, 35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cognitive behavioral therapy
Cognitive behavioral therapy for Major Depression
|
|
|
Geen tussenkomst: Waitlist group
Waitlist group to control for repeated physiological measures and fluctuations over time
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in depressive symptoms (BDI-II)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in heart rate variability
Tijdsspanne: 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 blood pressure
Tijdsspanne: 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 baroreceptor sensitivity (ms/mmHg)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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 proinflammatory cytokines
Tijdsspanne: 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 anti-inflammatory interleukin-10
Tijdsspanne: 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 Subjective social status (MacArthur scale)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Frank Euteneuer, PhD, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DFG EU 154 2 1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .