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

Philipps University

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Behavioral: CBASP; Behavioral: CBT - euthymic; Behavioral: CBT - active

Study type: Interventional

Funder types: Other

Identifiers

NCT01464463

DFG RI 574/23-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

CBT-active

Experimental group

Description:

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

Treatment:

Behavioral: CBT - active

CBT-euthymic

Active Comparator group

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)

Treatment:

Behavioral: CBT - euthymic

CBASP

Active Comparator group

Description:

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

Treatment:

Behavioral: CBASP

Waiting List

No Intervention group

Description:

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