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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: CBT - active
* Behavioral: CBT - euthymic
* Behavioral: CBASP


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-active<br>Patients with Major Depression (N = 50) get a common CBT treatment in combination with physical exercise. | Behavioral: CBT - active<br>* Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).<br>|
| Active Comparator: CBT-euthymic<br>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<br>* 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).<br>|
| Active Comparator: CBASP<br>Patients with Major Depression (N=50) get a cognitive therapy according to the Cognitive Behavioral Analysis System of Psychotherapy (CBASP). | Behavioral: CBASP<br>* 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.<br>|
| No Intervention: Waiting List<br>Patients randomized to the waiting list receive psychological treatment after waiting for 4 month. | |

What is the study measuring?
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Primary Outcome Measures

| 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 | 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

| 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 | 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 | 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 | 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 | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Exercise, Psychoneuroimmunology, Cognitive Behavioral Therapy, CBASP