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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: stress-coping week
* Behavioral: additional two days follow-up weekend


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting list, intervention after EOS<br>control group / waiting list one week stress-coping intervention planned after end of study (EOS) without one week stress-coping intervention AND without an additional two days follow-up care | |
| Active Comparator: Stress-coping week without follow-up<br>active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend | Behavioral: stress-coping week<br>* 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.<br>|
| Active Comparator: Stress-coping week with follow-up<br>active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend | Behavioral: stress-coping week<br>* 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.<br>Behavioral: additional two days follow-up weekend<br>* A two-days follow-up which recapitulates previous treatment elements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of saliva cortisol |  | Change from baseline saliva sample at week 1 to end of study visit at week 38 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of myeloperoxidase |  | Change from baseline at week 1 to end of study visit at week 38 | 
| Change of interleukin-6 |  | Change from baseline at week 1 to end of study visit at week 38 | 
| Change of homocystein |  | Change from baseline at week 1 to end of study visit at week 38 | 
| Change of psychometric stress-index (Questionnaire) |  | Change from baseline at week 1 to end of study visit at week 38 |