Work-focused Interpersonal Psychotherapy (W-IPT) versus treatment as usual for major depression related to work stress
- Conditions
- F32.1F32.2F33.1F33.2Moderate depressive episodeSevere depressive episode without psychotic symptomsRecurrent depressive disorder, current episode moderateRecurrent depressive disorder, current episode severe without psychotic symptoms
- Registration Number
- DRKS00011669
- Lead Sponsor
- niversitätsklinikum Freiburg, Zentrum für Psychische Erkrankungen, Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 28
•Primary diagnose of major depression (single-episode or recurrend), according to the Structured Clinical Interview for DSM-IV (SCID-I)
•depression score = 20, measured with 24-item version of the Hamilton Rating Scale for Depression (HRSD-24)
•work-related problems within the last 12 months, at least one of the following problems at work: (1) Mobbing, (2) interpersonal conflicts, (3) role transition, (4) role confusion, (5) burnout, (6) boreout, (7) job strain, (8) effort-reward-imbalance, (9) job demand-control imbalance (i.e. low dedicion latitiude, hight psychological demands), (10) work-life-imbalance, (11) low social support, (12) high job insecurity, (13) other work-related problems
•continuous medical treatment or psychiatric treatment
•during medical treatment: no change in the last four weeks before as well as within the twenty-week study periode (prevention of medication change effects during study period; in case of medication change during the study period it will be recorded as protocol violation.
•Age between 18 and 65
•native speaker German
•signed for informed consent
•acute suicidality (acute risc on the 5-item-suicide-risk scale)
•psychotic symptoms in clinical records
•bipolar disorder ( SCID-I)
•organic caused mental disorder
•other primary axis-I diagnosis
•concurrent substance abuse or dependency (SCID-I)
•antisocial personality disorder, schizotype or borderline personality disorder (SCID-II)
•severe physical sickness (which prevent patient from participation of the group program)
•unlimited pension applied or approved
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary analysis will be performed in the intention-to-treat (ITT) population. Primary endpoint (Hamilton Rating Scale for Depression HRSD-24, eight weeks after therapy start) will be analysed in a linear mixed model (intervention and baseline HRDS-24 as fixed effects). A conservative estimator of the effect size for the planned subsequent confirmatory study will be determined (two-sided 95% confidence intervall) in combination with clinical and statistical quantification.
- Secondary Outcome Measures
Name Time Method (+) W-IPT is more effective than the TAU intervention for ability of work improvement after eight week treatment: Work Ability Index (WAI), Return to Work Attitude (RTW-SE), Burnout-Mobbing-Inventory (BMI), Trier Inventory for Chronical Stress (TICS), Work-related Behaviour and Experience Patterns (AVEM).<br><br>(+) In the W-IPT group the remission rate (HRSD < 9) as well as the response rate (at least 50% reduction of the HRSD-24 sum score) will be higher in comparison to the TAU group.<br><br>(+) Depressive symptomatology (measured with the BDI-II, self-reported) will be lower in the W-IPT group in comparison to the TAU group.<br><br>(+) The general functioning (World Health Organization Disability Assessment Schedule/WHODAS 2.0) is significantly higher in the W-IPT group in comparison to the TAU group.<br><br>(+) Three months after completion of the treatment the depressive symptomatology (HRSD-24) in the W-IPT group will be lower in comparison to the TAU group.<br>