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

June 9, 2016 updated by: Winfried Rief, Philipps University Marburg Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35032
        • Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
C-reactive protein, inflammatory markers(Il-6, TNF-alpha, INF-gamma, IL-1ra, sTNF-RI, sTNF-RII) and anti-inflammatory cytokines (Il-10)
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
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
Symptom-Checklist by Derogatis (SCL-90-R; german adaption by Franke, 1995)
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 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
Trier inventary for chronic stress (TICS-K; Trierer Inventar zu chronischen Stress; Schulz et al., 2004)
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 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
Internationational Physical Activity Questionaire (IPAQ, Granger et al., 2000)
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)
Time Frame: 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)
From baseline to 16 weeks after baseline (end of therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universität Duisburg-Essen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Winfried Rief, Prof., Philipps University Marburg Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DFG RI 574/23-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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