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

Primary Purpose

Affective Disorders, Psychological Stress, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stress-coping week
additional two days follow-up weekend
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Affective Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    Waiting list, intervention after EOS

    Stress-coping week without follow-up

    Stress-coping week with follow-up

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change of saliva cortisol

    Secondary Outcome Measures

    Change of myeloperoxidase
    Change of interleukin-6
    Change of homocystein
    Change of psychometric stress-index (Questionnaire)

    Full Information

    First Posted
    April 7, 2016
    Last Updated
    September 15, 2016
    Sponsor
    Medical University of Vienna
    Collaborators
    Sanatorium Hera Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02752295
    Brief Title
    Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
    Acronym
    ISCIW
    Official Title
    Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna
    Collaborators
    Sanatorium Hera Vienna

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Affective Disorders, Psychological Stress, Inflammation, Oxidative Stress, Anxiety Disorders, Mood Disorders, Emotions

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Waiting list, intervention after EOS
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    Stress-coping week without follow-up
    Arm Type
    Active Comparator
    Arm Description
    active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend
    Arm Title
    Stress-coping week with follow-up
    Arm Type
    Active Comparator
    Arm Description
    active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend
    Intervention Type
    Behavioral
    Intervention Name(s)
    stress-coping week
    Intervention Description
    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
    Intervention Name(s)
    additional two days follow-up weekend
    Intervention Description
    A two-days follow-up which recapitulates previous treatment elements.
    Primary Outcome Measure Information:
    Title
    Change of saliva cortisol
    Time Frame
    Change from baseline saliva sample at week 1 to end of study visit at week 38
    Secondary Outcome Measure Information:
    Title
    Change of myeloperoxidase
    Time Frame
    Change from baseline at week 1 to end of study visit at week 38
    Title
    Change of interleukin-6
    Time Frame
    Change from baseline at week 1 to end of study visit at week 38
    Title
    Change of homocystein
    Time Frame
    Change from baseline at week 1 to end of study visit at week 38
    Title
    Change of psychometric stress-index (Questionnaire)
    Time Frame
    Change from baseline at week 1 to end of study visit at week 38

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24513877
    Citation
    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.
    Results Reference
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    Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients

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