Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02752295
Acronym
ISCIW
Enrollment
43
Registered
2016-04-26
Start date
2015-05-31
Completion date
2016-07-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Sponsors

Sanatorium Hera Vienna
CollaboratorUNKNOWN
Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change of myeloperoxidaseChange from baseline at week 1 to end of study visit at week 38
Change of interleukin-6Change from baseline at week 1 to end of study visit at week 38
Change of homocysteinChange 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026