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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list, intervention after EOS; 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; active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend	Behavioral: stress-coping week; 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.
Active Comparator: Stress-coping week with follow-up; active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend	Behavioral: stress-coping week; 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.; Behavioral: additional two days follow-up weekend; A two-days follow-up which recapitulates previous treatment elements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Sanatorium Hera Vienna

Publications and helpful links

General Publications

• Pilger A, Haslacher H, Ponocny-Seliger E, Perkmann T, Bohm K, Budinsky A, Girard A, Klien K, Jordakieva G, Pezawas L, Wagner O, Godnic-Cvar J, Winker R. Affective and inflammatory responses among orchestra musicians in performance situation. Brain Behav Immun. 2014 Mar;37:23-9. doi: 10.1016/j.bbi.2013.10.018. Epub 2013 Oct 26.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Disease; Inflammation; Anxiety Disorders; Stress, Psychological; Mood Disorders
• Other Study ID Numbers: ISCIW trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO