The Impact of Psychological Interventions on Psychometric and Immunological Measures in Patients With Major Depression
NCT ID: NCT01464463
Last Updated: 2016-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2011-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CBT-active
Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise.
CBT - active
Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
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)
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).
CBASP
Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP).
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.
Waiting List
Patients randomized to the waiting list receive psychological treatment after waiting for 4 month.
No interventions assigned to this group
Interventions
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CBT - active
Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
65 Years
ALL
Yes
Sponsors
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Universität Duisburg-Essen
OTHER
Philipps University Marburg
OTHER
Responsible Party
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Winfried Rief
Prof.Dr. / Principal investigator / Head of the department of clinical psychology and psychotherapy, Philipps University of Marburg
Principal Investigators
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Winfried Rief, Prof.
Role: STUDY_DIRECTOR
Philipps University Marburg
Locations
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Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
Marburg, , Germany
Countries
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Other Identifiers
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DFG RI 574/23-1
Identifier Type: -
Identifier Source: org_study_id
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