Depression Clinical Trial
Official title:
The Impact of Psychological Interventions (With and Without Exercise) on Psychometric and Immunological Measures in Patients With Major Depression
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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