Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients

Medical University of Vienna43 enrolled

Overview

This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients.

Affective disorders are associated with a substantial personal and socio-economic burden. This study evaluates an intensive brief stress-coping intervention week (ISCIW) as feasible follow-up treatment for real world patients who suffer from this highly prevalent and chronic stress-related disorders. Stress-associated blood (Interleukin-6, Homocystein, Myeloperoxidase), saliva cortisol and psychosocial screening parameters will be analyzed to determine who will benefit from the ISCIW. All patients were identified in a preventive medical screening before pre-treatment for at least three month as outpatient and the following inclusion to the follow-up ISCIW-trial at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria. For the three planed groups and interventions see interventions and arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Affective Disorders Psychological Stress Inflammation Oxidative Stress Anxiety Disorders Mood Disorders Emotions

Interventions

stress-coping weekBEHAVIORAL

The multidisciplinary team will offer Mindfulness-Based Stress Reduction (MBSR), group psychotherapy (resilience, Cognitive Behavioral Analysis System of Psychotherapy CBASP, psychodynamic therapy), relaxation training, nutrition course, stress-coping and physical training in a group setting.

additional two days follow-up weekendBEHAVIORAL

A two-days follow-up which recapitulates previous treatment elements.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Affective or anxiety disorder DSM-IV diagnosis (structured interview, M.I.N.I. International Neuropsychiatric Interview ) * Minimum 3-weeks previous therapeutic treatment as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria * Clinical Global Impression - Severity (CGI-S) score \> 2 points * Minimum improvement of 1 CGI-S points as outpatient * Written informed consent Exclusion Criteria: * More than 60 days away sick per year in the last year before intervention * Therapy adherence as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria * Work Ability Index (WAI) score \< 25 points * Major neurological or cognitive deficits * Current psychotic symptoms * Current or previous DSM-IV diagnosis of substance dependence, except for nicotine or current substance abuse * Failures to comply with the study protocol or to follow the instructions of the study team * Currently requested application for retirement * Middle to high suicidal tendency in the M.I.N.I.-examination

Outcomes

Primary Outcomes

Change of saliva cortisol

Time frame: Change from baseline saliva sample at week 1 to end of study visit at week 38

Secondary Outcomes

Change of myeloperoxidase

Time frame: Change from baseline at week 1 to end of study visit at week 38

Change of interleukin-6

Time frame: Change from baseline at week 1 to end of study visit at week 38

Change of homocystein

Time frame: Change from baseline at week 1 to end of study visit at week 38

Change of psychometric stress-index (Questionnaire)

Time frame: Change from baseline at week 1 to end of study visit at week 38

Data from ClinicalTrials.gov

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