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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02752295

Collaborator

Sanatorium Hera Vienna (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Affective Disorders Psychological Stress Inflammation Oxidative Stress Anxiety Disorders Mood Disorders Emotions	Behavioral: stress-coping week Behavioral: additional two days follow-up weekend	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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.

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

Behavioral: additional two days follow-up weekend

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

Outcome Measures

Primary Outcome Measures

Change of saliva cortisol [Change from baseline saliva sample at week 1 to end of study visit at week 38]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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