Clinical trial NCT02752295: Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
Official title: Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorders
Psychological Stress
Inflammation
Oxidative Stress
Anxiety Disorders
Mood Disorders
Emotions
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Sanatorium Hera Vienna
First posted: 2016-04-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of saliva cortisol
timeFrame: Change from baseline saliva sample at week 1 to end of study visit at week 38
Secondary outcomes:
measure: Change of myeloperoxidase
timeFrame: Change from baseline at week 1 to end of study visit at week 38
measure: Change of interleukin-6
timeFrame: Change from baseline at week 1 to end of study visit at week 38
measure: Change of homocystein
timeFrame: Change from baseline at week 1 to end of study visit at week 38
measure: Change of psychometric stress-index (Questionnaire)
timeFrame: Change from baseline at week 1 to end of study visit at week 38
Other outcomes:
Locations:
Study officials:
References:
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.