The Impact of Psychological Interventions (With and Without Exercise) on Psychometric and Immunological Measures in Patients With Major Depression
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Philipps University Marburg Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Winfried Rief
Prof.Dr. / Principal investigator / Head of the department of clinical psychology and psychotherapy, Philipps University of Marburg
Philipps University Marburg Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
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.)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- Changes from baseline to 16 weeks after baseline (end of therapy)(From baseline to 16 weeks after baseline (end of therapy))
- 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)