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

NCT01464463 | Completed Phase 3

• 1 other identifier: DFG RI 574/23-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Exercise; Psychoneuroimmunology; Cognitive Behavioral Therapy; CBASP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

  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

  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

  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)

  From baseline to 16 weeks after baseline (end of therapy)

Study Arms (4)

CBT-active

EXPERIMENTAL

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

Behavioral: CBT - active

CBT-euthymic

ACTIVE COMPARATOR

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

CBASP

ACTIVE COMPARATOR

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

Behavioral: CBASP

Waiting List

NO INTERVENTION

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

Interventions

CBT - active BEHAVIORAL

Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).

CBT-active

CBT - euthymic BEHAVIORAL

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).

CBT-euthymic

CBASP BEHAVIORAL

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.

CBASP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Philipps University Marburg: lead
• Universität Duisburg-Essen: collaborator

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps University Marburg

Marburg, 35032, Germany

Location

MeSH Terms

Conditions

Depression; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Winfried Rief, Prof.

  Philipps University Marburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. / Principal investigator / Head of the department of clinical psychology and psychotherapy, Philipps University of Marburg

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 3, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

DE (1)