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. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Depression
Behavioral: CBT - active
Behavioral: CBT - euthymic
Behavioral: CBASP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Psychological Interventions (With and Without Exercise) on Psychometric and Immunological Measures in Patients With Major Depression

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-active
Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise.
Behavioral: CBT - active
Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
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)
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).
Active Comparator: CBASP
Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP).
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.

No Intervention: Waiting List
Patients randomized to the waiting list receive psychological treatment after waiting for 4 month.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464463

Contacts
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

Locations
Germany
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg Recruiting
Marburg, Germany, 35032
Contact: Frank Euteneuer, Dipl.Psych.    +49-6421-2823350    frank.euteneuer@staff.uni-marburg.de   
Contact: Katharina Dannehl, Dipl.Psych.    +49-6421-2823347    dannehl@staff.uni-marburg.de   
Principal Investigator: Winfried Rief, Prof. Dr.         
Sub-Investigator: Frank Euteneuer, Dipl.Psych.         
Sub-Investigator: Katharina Dannehl, Dipl.Psych.         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Universität Duisburg-Essen
Investigators
Study Director: Winfried Rief, Prof. Philipps University Marburg Medical Center
  More Information

No publications provided

Responsible Party: Winfried Rief, Prof.Dr. / Principal investigator / Head of the department of clinical psychology and psychotherapy, Philipps University of Marburg, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01464463     History of Changes
Other Study ID Numbers: DFG RI 574/23-1
Study First Received: October 19, 2011
Last Updated: November 13, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
Depression
Exercise
Psychoneuroimmunology
Cognitive Behavioral Therapy
CBASP

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014