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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Marburg, Tyskland, 35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Cognitive behavioral therapy
Cognitive behavioral therapy for Major Depression
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Ingen inngripen: Waitlist group
Waitlist group to control for repeated physiological measures and fluctuations over time
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in depressive symptoms (BDI-II)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in heart rate variability
Tidsramme: 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 blood pressure
Tidsramme: 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 baroreceptor sensitivity (ms/mmHg)
Tidsramme: 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 peripheral vascular resistance (dyne*s/cm5)
Tidsramme: 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 C-reactive protein
Tidsramme: 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 proinflammatory cytokines
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Frank Euteneuer, PhD, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DFG EU 154 2 1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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