Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 43
- Primary Endpoint
- Change of saliva cortisol
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Waiting list, intervention after EOS
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 with one week stress-coping intervention BUT without an additional two days follow-up weekend
Intervention: stress-coping week (Behavioral)
Stress-coping week with follow-up
active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend
Intervention: stress-coping week (Behavioral)
Stress-coping week with follow-up
active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend
Intervention: additional two days follow-up weekend (Behavioral)
Outcomes
Primary Outcomes
Change of saliva cortisol
Time Frame: Change from baseline saliva sample at week 1 to end of study visit at week 38
Secondary Outcomes
- 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 psychometric stress-index (Questionnaire)(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)
Investigators
Robert Winker
Prim.Priv. Doz. Dr.
Medical University of Vienna