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

Not Applicable

Completed

• Conditions: Psychological Stress; Anxiety Disorders; Mood Disorders; Inflammation; Affective Disorders; Oxidative Stress; Emotions
• Interventions: Behavioral: stress-coping week; Behavioral: additional two days follow-up weekend

• Registration Number: NCT02752295
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress-coping week without follow-up	stress-coping week	active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend
Stress-coping week with follow-up	stress-coping week	active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend
Stress-coping week with follow-up	additional two days follow-up weekend	active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend

Primary Outcome Measures

Name	Time	Method
Change of saliva cortisol	Change from baseline saliva sample at week 1 to end of study visit at week 38

Secondary Outcome Measures

Name	Time	Method
Change of interleukin-6	Change from baseline at week 1 to end of study visit at week 38
Change of myeloperoxidase	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
Change of homocystein	Change from baseline at week 1 to end of study visit at week 38