Trial document




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  DRKS00011669

Trial Description

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Title

Work-focused Interpersonal Psychotherapy (W-IPT) versus treatment as usual for major depression related to work stress

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Trial Acronym

W-IPT

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URL of the Trial

https://www.uniklinik-freiburg.de/psych/forschung-research/research-groups/rg-schramm/project-7.html

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Brief Summary in Lay Language

Objective:
The purpose of the program is a specific therapy for work-related problems, which should lead to a permanent remission from depression.

Brief description:
The work-related group program is based on the Interpersonal Psychotherapy (IPT), a specific and effective depression therapy. In this respect especially the following contents will be considered: stressful events, social roles and relationships in working context. Within the framework of the therapy individual risk factors in stress experience as well as personal imbalances (e.g. work effort and appreciation in work) will be worked out. Strategies for more balance between everyday life and work life will be acquired in order to pursue a value oriented way of living.

Study members:
Possible study members are between 18 and 65 years old with an acute major depression and work-related problems (e.g. conflicts in the workplace, high workload, work-related stress). In addition, the members need good knowledge of the German language and connection to an attending physician.
The patients run through a full diagnostic examination before and after the intervention.
Participants will be randomly assigned to one of the two conditions: work-related interpersonal group (W-IPT) or conventional medical treatment (TAU, treatment as usual). The participants of the W-IPT group start immediately with the eight-week group program. The TAU group participants, on the other hand, continue their current treatment (e.g. medication, psychotherapy). After the 20-weeks-duration of the study they are offered to participate to a W-IPT as well, without additive costs.

Hypotheses:
The work-related interpersonal group psychotherapy intervention leads to a greater improvement of depressive symptoms than the conventional medical treatment.

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Brief Summary in Scientific Language

The purpose of the program is a specific therapy for work-related problems, which should lead to a permanent remission from depression.
The work-related group program is based on the Interpersonal Psychotherapy (IPT), a specific and effective depression therapy. In this respect especially the following contents will be considered: stressful events, social roles and relationships in working context. Within the framework of the therapy individual risk factors in stress experience as well as personal imbalances (e.g. work effort and appreciation in work) will be worked out. Strategies for more balance between everyday life and work life will be acquired in order to pursue a value oriented way of living.
The authors assume that, after an eight-week-intervention, work-related interpersonal group psychotherapy (W-IPT) results in an enhanced improvement of depressive symptomatology as this is possible with the conventional medical treatment (TAU, treatment as usual). Secondly, the W-IPT should result more effective in the ability of work improvement regarding some indicators such as the work ability index (WAI). Furthermore, the authors expect a significant higher general functioning in the W-IPT group as well as a higher remission (HRSD < 9) and response rate (at least 50% reduction of HRSD-24).
Possible study members are between 18 and 65 years old with an acute major depression and work-related problems (e.g. conflicts in the workplace, high workload, and work-related stress). In addition, the members need good knowledge of the German language and connection to an attending physician.
The patients run through a full diagnostic examination before and after the intervention.
They are randomly assigned to the two conditions (W-IPT or TAU). The participants of the W-IPT group start immediately with the eight-week group program. The TAU group participants, on the other hand, initially continue their current treatment (e.g. medication, psychotherapy). After the 20-weeks-duration of the study they are offered to participate to a W-IPT as well, without additive costs.

Hypotheses:
The work-related interpersonal group psychotherapy intervention leads to a greater improvement of depressive symptoms than the conventional medical treatment.

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Organizational Data

  •   DRKS00011669
  •   2017/03/14
  •   [---]*
  •   no
  •   Approved
  •   389/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   W-IPT: W-IPT: Work-related Interpersonal Psychotherapy will follow a manual (Schramm & Thiel, 2015). The intervention is focused on work stress related depression by adding specific elements to the regular IPT strategies: identification of work related stress factors by using a stress- and resource profile, learn of mindfulness and coping strategies at work-related stress, practice of social communication skills and the recovery of the balance between performance values and interpersonal values. By applying those strategies, social and interpersonal problems at work are addressed (such as mobbing, interpersonal conflicts, role transition, role confusion, burnout, boreout, job strain, low social support, effort-reward-imbalance, job demand-control imbalance, and work-life-imbalance). The intervention includes one weekly group session of 90 minutes for 6 – 8 outpatients over 8 weeks.
  •   Treatment as usual (TAU, Guideline oriented treatment by a primary care physician, psychiatrist, or licensed psychotherapist during the study period. Patients already in psychiatric or psychotherapeutic treatment at study intake can go on with their medications and consultations. There are no restrictions on other forms of supplementary treatment. Current national guidelines recommend antidepressants or psychotherapy as mono- or combination therapy for patients with moderate to severe MDD). Patients of the control group can participate in the W-IPT program after the evaluation of the follow-up.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Treatment
  •   Parallel
  •   IIb
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

(+) 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).

(+) 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.

(+) Depressive symptomatology (measured with the BDI-II, self-reported) will be lower in the W-IPT group in comparison to the TAU group.

(+) 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.

(+) 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/01
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

•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

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Exclusion Criteria

•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

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Addresses

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    • Universitätsklinikum Freiburg, Zentrum für Psychische Erkrankungen, Klinik für Psychiatrie und Psychotherapie
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Elisabeth  Schramm 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
    • Ms.  Dr.  Hannah  Piosczyk 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg
    • Königstraße 46
    • 70173  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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