Trial document




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  DRKS00021189

Trial Description

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Title

Improve-3: Subproject for the assessment of cost-effectiveness of the IMPROVE-MH intervention in refugee families

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Trial Acronym

IMPROVE-MH-3

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URL of the Trial

https://www.kli.psy.ruhr-uni-bochum.de/kkjp/aktuelles.html#Forschungsprojekte_2019

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Brief Summary in Lay Language

Among refugees, mental health problems are highly prevalent. Approximately more than 50% of the refugees who fled armed conflicts are affected by mental health problems, such as depression or anxiety. Parental mental health problems as well as an unfavorable parenting style are major risk factors for children to develop mental health problems as well.

The goal of this BMBF-funded research project is the assessment of the IMPROVE-MH intervention in refugee families with young children in terms of its cost-effectiveness. For this purpose, parents with mental health problems will receive an intervention (10 weeks) via general practitioners. This intervention includes a short treatment (4 consultations) to deal with symptoms of anxiety, stress and depression as well as an online training to promote a positive parenting style and accompanying phone calls with a psychologist. Psychologically strained refugee families with young children (0-6 years) and Arabic language skills can join the study.

To examine the cost-effectiveness of the Improve intervention program compared to a treatment as usual, parents are invited to take part in interviews on mental health outcomes and fill in questionnaires prior, during and after the treatment. The aim is to investigate, if the Improve intervention is superior shows a favourable and acceptable incremental cost-effectiveness ratio compared to a treatment as usual.

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Brief Summary in Scientific Language

The planned research project is a data analysis of a multicenter cooperative project (DRKS00019072), including different sub-projects. The project is based on an intervention for refugee parents with mental health issues, implemented as a randomized control trial (P1). This subproject constitutes a cost-effectiveness analysis of the IMPROVE intervention (P3).

Mentally strained refugee parents (with children between 0-6 years) with Arabic language skills, who experience elevated stress, depressive or anxious symptoms are invited to take part in the study.
The intervention will take 10 weeks and includes three aspects (4 consultations in the general practice, online parenting program Triple P and regular phone calls with a psychologist) and will be compared to a treatment as usual.

Primary outcomes are the incremental cost-effectiveness ratio (ICER) as point estimate as well as the cost-effectiveness acceptability curve (CEAC) as measure of uncertainty. Direct health care costs will be calculated. Health-care categories specific for children will be considered. As primary effect measure quality-adjusted life years (QALY) of the parents will be calculated. Secondary outcome are days without mental-health burden specifically calculated for parents and children. Additionally, we will also assess parenting style sociodemographic, psychosocial variables, physical health, stress (hair cortisol), and possible side-effects of the intervention. Time points are pre (T0), post (T1), such as a 6- (T2) and 12 -month follow-up (T3) in the major assessment. Selected variables will be also assessed directly after the treatment in the general practice (minor assessment) or during the phone calls (intermediate assessment).


Hypothesis of the cost-effectiveness analysis (P3) include:
Hypothesis 1): an increase of direct health care costs caused by parents and children after 12 months due to an improvement of health care access by the intervention
Hypothesis 2): a higher number of quality-adjusted life years and days without mental health burden for parents and children in the intervention group after 12 months.
Hypothesis 3): A cost-effectiveness ratio < 50.000€/QALY and a probability of cost effectiveness of >95% of the intervention.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

A part of the anonymised data will be published on an internet database. No data that enables personal tracking will be published (e.g. data regarding the residence or date of birth). Data security officer will be consulted before data selection.

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Organizational Data

  •   DRKS00021189
  •   2020/04/01
  •   [---]*
  •   yes
  •   Approved
  •   602, Bochum - Lokale Ethikkomission der Fakultät für Psychologie (RUB) Fakultät für Psychologie Ethikkommission Der Vorsitzende Gebäude: IB 5/117 Universitätsstraße 150 44801 Bochum http://www.psy.ruhr-uni-bochum.de/zentralebereiche/ethik.html.de
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Secondary IDs

  •   DRKS00019072  (Verbundstudie)
  •   DRKS00021227  (Verbundstudie)
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Health Condition or Problem studied

  •   F41 -  Other anxiety disorders
  •   F32 -  Depressive episode
  •   F43 -  Reaction to severe stress, and adjustment disorders
  •   F33 -  Recurrent depressive disorder
  •   F40 -  Phobic anxiety disorders
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Interventions/Observational Groups

  •   In this subproject no interventions will be performed.
    Analyses of data from a randomized controlled trial will be conducted exclusively.
    For information on the intervention, please see: DRKS00019072
  •   In this subproject no interventions will be performed.
    Analyses of data from a randomized controlled trial will be conducted exclusively.
    For information on the control, please see: DRKS00019072
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Blinded
  •   assessor
  •   Other
  •   Health economics
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Primary outcomes are the ICER and CEAC based on direct health care costs of parents and children as well as the QALY of the parents.

-Direct health care costs: modified version of the Client Sociodemographic and Service Receipt Inventory (CSSRI), original version by Chisholm et al (2000), german version by Roick et al (2001). The questionnaire in this study is based on the German version. Monetary valuation of resource utilization is based on the standardized valuation set by Bock et al (2015).

-Quality of life assessment for QALY calculation: EQ-5D-5L, original version by Herdman et al (2011). In this study, we use the official German translation by the EuroQol group. For the valuation of health states we use the German value set calculated by Ludwig, von der Schulenburg und Greiner (2018).

All primary outcomes will be assessed pre, and at 6- and 12-months follow-up.

The analysis is based on the 12-month total costs and QALY. We will use analytical approaches appropriate for the distribution of the data.

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Secondary Outcome

Secondary endpoints are days without mental health burden. Mental health burden of parents and children will be assessed by group-specific instruments.

Parents: Depression Anxiety and Stress Scale (DASS-21): Original version by Lovibond and Lovibond (1995), German short version by Nilges and Essau (2015), Arabic version by Moussa, Lovibond, Laube, and Megahead (2017).

Children: SDQ-P (Strengths and Difficulties Questionnaire): Original version by Goodman (1994), German version by Klasen et al. (2005), Arabic version by Alyahri et al. (2005); Alyahri and Goodman (2006).
The analysis is based on days without mental health burden after 12 months. Days without mental health burden will be calculated based on the method by Lave, Frank, Schulberg and Kamlet (1998). We will use analytical approaches appropriate for the distribution of the data.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2020/06/01
  •   375
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

1) Refugee parents
(2) child(ren) aged 0-6 years
(3) Arabic language skills
(4) meeting clinical cut-off on Depression Anxiety Stress Scales (DASS-21)

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Exclusion Criteria

Key exclusion criteria:
(1) other primary mental health problems
(2) neuroleptic, anticholinergic and/or antiepileptic drugs or concurrent psychotherapy
(3) acute suicidality
(4) general medical contraindications

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf Institut für Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Prof. Dr.  Hans-Helmut  König 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Fakultät für Psychologie, Klinische Kinder- und Jugendpsychologie, Ruhr-Universität Bochum
    • Ms.  Prof. Dr.  Silvia  Schneider 
    • Massenbergstr. 9-13
    • 44787  Bochum
    • Germany
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    • Klinikum der Ludwig-Maximilians-Universität München Institut für Allgemeinmedizin Campus Innenstadt
    • Mr.  Prof. Dr.  Jochen  Gensichen 
    • Pettenkoferstr. 10
    • 80336  München
    • Germany
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    • Ruhr-Universität Bochum Medizinische Fakultät Allgemeinmedizin Gebäude MAFO 1/61
    • Mr.  Prof. Dr.  Horst Christian  Vollmar 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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    • Universitätsmedizin Essen Universitätsklinikum Institut für Allgemeinmedizin
    • Ms.  Martina  Heßbrügge 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Ruhr-Universität Bochum Fakultät für Psychologie Arbeitseinheit psychologische Methodenlehre IB 4/185
    • Ms.  Prof. Dr.  Maike  Luhmann 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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    • Ruhr-Universität BochumFakultät für PsychologieAE Genetic Psychology
    • Mr.  Prof. Dr.  Robert  Kumsta 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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    • Ruhr-Universität Bochum Fakultät für Psychologie Klinische Psychologie
    • Mr.  Prof.  Jürgen  Margraf 
    • Massenbergstr. 9-13
    • 44787  Bochum
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Institut für Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Dr.  Christian  Brettschneider 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Ruhr-Universität Bochum Forschungs- und Behandlungszentrum für psychische Gesundheit (FBZ), Klinische Kinder- und Jugendpsychologie, Fakultät für Psychologie
    • Ms.  Dr.  Kerstin  Konietzny 
    • Massenbergstraße 9-13
    • 44787  Bochum
    • Germany
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    • Ruhr-Universität Bochum Forschungs- und Behandlungszentrum für psychische Gesundheit (FBZ) Klinische Kinder- und Jugendpsychologie Fakultät für Psychologie
    • Mr.  Dr.  Omar  Chehadi 
    • Massenbergstr. 9-13
    • 44787  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.