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

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)

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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