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

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
CBT - active
CBT - euthymic
CBASP
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Exercise, Psychoneuroimmunology, Cognitive Behavioral Therapy, CBASP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

CBT-active

CBT-euthymic

CBASP

Waiting List

Arm Description

Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise.

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)

Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP).

Patients randomized to the waiting list receive psychological treatment after waiting for 4 month.

Outcomes

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
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
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
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
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
Internationational Physical Activity Questionaire (IPAQ, Granger et al., 2000)
Changes from baseline to 16 weeks after baseline (end of therapy)
Verbal test for learning- and memory abilities (Verbaler Lern- und Merkfähigkeitstest-VLMT; Helmstaedter, Lendt, Lux, 2001)

Full Information

First Posted
October 19, 2011
Last Updated
June 9, 2016
Sponsor
Philipps University Marburg Medical Center
Collaborators
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01464463
Brief Title
The Impact of Psychological Interventions on Psychometric and Immunological Measures in Patients With Major Depression
Official Title
The Impact of Psychological Interventions (With and Without Exercise) on Psychometric and Immunological Measures in Patients With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Exercise, Psychoneuroimmunology, Cognitive Behavioral Therapy, CBASP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT-active
Arm Type
Experimental
Arm Description
Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise.
Arm Title
CBT-euthymic
Arm Type
Active Comparator
Arm Description
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)
Arm Title
CBASP
Arm Type
Active Comparator
Arm Description
Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP).
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
Patients randomized to the waiting list receive psychological treatment after waiting for 4 month.
Intervention Type
Behavioral
Intervention Name(s)
CBT - active
Intervention Description
Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
Intervention Type
Behavioral
Intervention Name(s)
CBT - euthymic
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
CBASP
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Becks Depression Inventory II (BDI-II; german adaptation by Hautzinger, Kühner & Keller, 2006)
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
Secondary Outcome Measure Information:
Title
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
Description
C-reactive protein, inflammatory markers(Il-6, TNF-alpha, INF-gamma, IL-1ra, sTNF-RI, sTNF-RII) and anti-inflammatory cytokines (Il-10)
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
Title
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
Description
Symptom-Checklist by Derogatis (SCL-90-R; german adaption by Franke, 1995)
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
Title
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
Description
Trier inventary for chronic stress (TICS-K; Trierer Inventar zu chronischen Stress; Schulz et al., 2004)
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
Title
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
Description
Internationational Physical Activity Questionaire (IPAQ, Granger et al., 2000)
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
Title
Changes from baseline to 16 weeks after baseline (end of therapy)
Description
Verbal test for learning- and memory abilities (Verbaler Lern- und Merkfähigkeitstest-VLMT; Helmstaedter, Lendt, Lux, 2001)
Time Frame
From baseline to 16 weeks after baseline (end of therapy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany

12. IPD Sharing Statement

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

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