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

Inflammation Clinical Trial

— ISCIW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752295
• Other study ID #: ISCIW trial
• Status: Completed
• Phase: N/A
• First received: April 7, 2016
• Last updated: September 15, 2016
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• stress-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.
• additional two days follow-up weekend
A two-days follow-up which recapitulates previous treatment elements.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Sanatorium Hera Vienna

References & Publications (1)

Pilger A, Haslacher H, Ponocny-Seliger E, Perkmann T, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of saliva cortisol		Change from baseline saliva sample at week 1 to end of study visit at week 38	No
Secondary	Change of myeloperoxidase		Change from baseline at week 1 to end of study visit at week 38	No
Secondary	Change of interleukin-6		Change from baseline at week 1 to end of study visit at week 38	No
Secondary	Change of homocystein		Change from baseline at week 1 to end of study visit at week 38	No
Secondary	Change of psychometric stress-index (Questionnaire)		Change from baseline at week 1 to end of study visit at week 38	No