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CompletedNCT02752295ISCIWUpdated Sep 16, 2016

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

An interventional study of stress-coping week and additional two days follow-up weekend in Affective Disorders, Psychological Stress and Inflammation, sponsored by Medical University of Vienna. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Affective Disorders
  • Psychological Stress
  • Inflammation
  • Oxidative Stress
  • Anxiety Disorders
  • Mood Disorders
  • Emotions
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 43 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralstress-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.

  • Behavioraladditional two days follow-up weekend

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

06

What researchers measure

Primary outcomes

  1. Change of saliva cortisol

    Time frame: Change from baseline saliva sample at week 1 to end of study visit at week 38

Secondary outcomes

  1. Change of myeloperoxidase

    Time frame: Change from baseline at week 1 to end of study visit at week 38

  2. Change of interleukin-6

    Time frame: Change from baseline at week 1 to end of study visit at week 38

  3. Change of homocystein

    Time frame: Change from baseline at week 1 to end of study visit at week 38

  4. Change of psychometric stress-index (Questionnaire)

    Time frame: Change from baseline at week 1 to end of study visit at week 38

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 24513877 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02752295
Lead sponsor
Medical University of Vienna
Collaborators
Sanatorium Hera Vienna
Responsible party
Robert Winker (Prim.Priv. Doz. Dr., Medical University of Vienna) — Principal investigator
First posted
Apr 26, 2016
Start date
May 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Sep 16, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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