NCT01464463

The Impact of Psychological Interventions on Psychometric and Immunological Measures in Patients With Major Depression

The Impact of Psychological Interventions (With and Without Exercise) on Psychometric and Immunological Measures in Patients With Major Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	CBT - active	Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
BEHAVIORAL	CBT - euthymic	Patients get the same common CBT treatment as group I, but instead of physical exercise they receive an enjoyment training Patients get CBT treatment combined with euthymic exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
BEHAVIORAL	CBASP	Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, psychodynamic and interpersonal strategies. Foci of the CBASP-therapy are situation analysis and subsequent behavioral trainings as well as interpersonal strategies to create a therapeutic relationship.

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-04-01
• First posted: 2011-11-03
• Last updated: 2016-06-10

Locations

1 site across 1 country: Germany