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

NCT ID: NCT02752295

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-07-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Stress-coping week without follow-up

active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend

Group Type ACTIVE_COMPARATOR

stress-coping week

Intervention Type BEHAVIORAL

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.

Stress-coping week with follow-up

active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend

Group Type ACTIVE_COMPARATOR

stress-coping week

Intervention Type BEHAVIORAL

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 weekend

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

additional two days follow-up weekend

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanatorium Hera Vienna

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Robert Winker

Prim.Priv. Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 24513877 (View on PubMed)

Other Identifiers

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ISCIW trial

Identifier Type: -

Identifier Source: org_study_id

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