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

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Medical University of Vienna

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02752295
ISCIW trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 3 patient groups

Waiting list, intervention after EOS
No Intervention group
Description:
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 group
Description:
active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend
Treatment:
Behavioral: stress-coping week
Stress-coping week with follow-up
Active Comparator group
Description:
active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend
Treatment:
Behavioral: stress-coping week
Behavioral: additional two days follow-up weekend

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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