The Impact of Psychological Interventions on Psychometric and Immunological Measures in Patients With Major Depression
- Conditions
- Depression
- Interventions
- Behavioral: CBT - euthymicBehavioral: CBASPBehavioral: CBT - active
- Registration Number
- NCT01464463
- Lead Sponsor
- Philipps University Marburg Medical Center
- Brief Summary
The objective of this study is to compare the impact of i) Cognitive Behavioral Therapy (CBT) combined with exercise, ii)CBT combined with euthymic therapy, and iii) 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) on psychometric and immunological measures in patients with major depression.
- Detailed Description
The interest of the investigation is to compare the impact of CBT combined with exercise, CBT combined with euthymic therapy and CBASP on depression and further psychopathological variables (assessed at 5 points).
Previous findings indicate increased concentration of pro-inflammatory cytokines in depression. A bidirectional relationship between depression and immunological alterations has been suggested: On the one hand pro-inflammatory cytokines may contribute to depression, on the other hand depression-linked changes (e.g. a reduction of activity, increased stress-sensitivity) may lead to increased secretion of pro-inflammatory cytokines. Therefore, this study is also supposed to investigate the influence of above mentioned interventions on pro-inflammatory cytokines. Using a waiting group, potential changes in psychometric and biological parameters without any intervention are controlled. Assessments take place at baseline, after 4 weeks of treatment, after 8 weeks of treatment, after 16 weeks of treatment and 6 months follow up.
200 patients with Major Depression (DSM IV, BDI II at baseline ≥18) will be included. Patients will be randomized and assigned to one of the 4 groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- patients with Major Depression (DSM IV), BDI >=18
- age:18-65 years
- patients with and without antidepressive medication
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT-euthymic CBT - euthymic Patients with Major Depression (N = 50) get the same common CBT treatment as the CBT-active-group, but instead of physical exercise they receive an enjoyment training, which is based on exercises from the "Kleine Schule des Genießens" (Koppenhöfer, 2004) CBASP CBASP Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP). CBT-active CBT - active Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise.
- Primary Outcome Measures
Name Time Method Changes in severity of depressive symptoms from baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up From baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up Becks Depression Inventory II (BDI-II; german adaptation by Hautzinger, Kühner \& Keller, 2006)
- Secondary Outcome Measures
Name Time Method Changes in self-rated physical activity from baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up From baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up Internationational Physical Activity Questionaire (IPAQ, Granger et al., 2000)
Changes in immunological measures from baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up From baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up C-reactive protein, inflammatory markers(Il-6, TNF-alpha, INF-gamma, IL-1ra, sTNF-RI, sTNF-RII) and anti-inflammatory cytokines (Il-10)
Changes in psychopathological variables from baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up From baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up Symptom-Checklist by Derogatis (SCL-90-R; german adaption by Franke, 1995)
Changes from baseline to 16 weeks after baseline (end of therapy) From baseline to 16 weeks after baseline (end of therapy) Verbal test for learning- and memory abilities (Verbaler Lern- und Merkfähigkeitstest-VLMT; Helmstaedter, Lendt, Lux, 2001)
Changes in perceived stress from baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up From baseline (beginning of therapy) to 4 weeks after baseline, to 8 weeks after baseline, to 16 weeks after baseline (end of therapy) to 6-month-follow up Trier inventary for chronic stress (TICS-K; Trierer Inventar zu chronischen Stress; Schulz et al., 2004)
Trial Locations
- Locations (1)
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
🇩🇪Marburg, Germany