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

This study is currently recruiting participants.
Verified November 2013 by Philipps University Marburg Medical Center
Sponsor:
Collaborator:
Universität Duisburg-Essen
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01464463
First received: October 19, 2011
Last updated: November 13, 2013
Last verified: November 2013

October 19, 2011
November 13, 2013
August 2011
July 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Becks Depression Inventory II (BDI-II; german adaptation by Hautzinger, Kühner & Keller, 2006)
Same as current
Complete list of historical versions of study NCT01464463 on ClinicalTrials.gov Archive Site
  • 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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    Symptom-Checklist by Derogatis (SCL-90-R; german adaption by Franke, 1995)
  • 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 [ 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 ] [ Designated as safety issue: No ]
    Trier inventary for chronic stress (TICS-K; Trierer Inventar zu chronischen Stress; Schulz et al., 2004)
  • 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 [ 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 ] [ Designated as safety issue: No ]
    Internationational Physical Activity Questionaire (IPAQ, Granger et al., 2000)
  • Changes from baseline to 16 weeks after baseline (end of therapy) [ Time Frame: From baseline to 16 weeks after baseline (end of therapy) ] [ Designated as safety issue: No ]
    Verbal test for learning- and memory abilities (Verbaler Lern- und Merkfähigkeitstest-VLMT; Helmstaedter, Lendt, Lux, 2001)
Same as current
Not Provided
Not Provided
 
The Impact of Psychological Interventions (With and Without Exercise) 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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • 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.

  • Experimental: CBT-active
    Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise.
    Intervention: Behavioral: CBT - active
  • Active Comparator: 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)
    Intervention: Behavioral: CBT - euthymic
  • Active Comparator: CBASP
    Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP).
    Intervention: Behavioral: CBASP
  • No Intervention: Waiting List
    Patients randomized to the waiting list receive psychological treatment after waiting for 4 month.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
July 2014   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 65 Years
Yes
Contact: Winfried Rief, Prof. Dr. +49-6421-2823657 rief@staff.uni-marburg.de
Contact: Frank Euteneuer, Dipl.Psych. +49-6421-2823350 euteneuer@staff.uni-marburg.de
Germany
 
NCT01464463
DFG RI 574/23-1
No
Winfried Rief, Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
Universität Duisburg-Essen
Study Director: Winfried Rief, Prof. Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP