NCT02752295

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

April 7, 2016

Last Update Submit

September 15, 2016

Conditions

Affective DisordersPsychological StressInflammationOxidative StressAnxiety DisordersMood DisordersEmotions

Outcome Measures

Primary Outcomes (1)

  • Change of saliva cortisol

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

Secondary Outcomes (4)

  • 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

Study Arms (3)

Waiting list, intervention after EOS

NO INTERVENTION

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

Stress-coping week without follow-up

ACTIVE COMPARATOR

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

Behavioral: stress-coping week

Stress-coping week with follow-up

ACTIVE COMPARATOR

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

Behavioral: stress-coping weekBehavioral: additional two days follow-up weekend

Interventions

stress-coping weekBEHAVIORAL

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-upStress-coping week without follow-up
additional two days follow-up weekendBEHAVIORAL

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

Stress-coping week with follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24513877BACKGROUND

MeSH Terms

Conditions

Mood DisordersStress, PsychologicalInflammationAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim.Priv. Doz. Dr.

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 26, 2016

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share