Skip to main content
OpenTrials
Completed

NCT Number: NCT02752295

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stress-coping week

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

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Sanatorium Hera Vienna

Registry information

Acronym: ISCIW

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2016
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.