Trial document




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  DRKS00017010

Trial Description

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Title

Horse-assisted biografical work for individuals in the second half of life

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Trial Acronym

PBA-E

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URL of the Trial

https://www.bildung.uni-siegen.de/mitarbeiter/forstmeier/project9.html

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Brief Summary in Lay Language

The horse is used in the various social, educational, therapeutic and medical fields of action because of its diverse impact factors. The central target group of this supplementary treatment approach are children and adolescents who have a holistic need for support. However, preventive (prophylactic) approaches for older people have hardly been taken into account in both specialist literature and horse-assisted therapy, although they may possibly look back on a common history of development with the horse as a work and farm animal.
The second half of life (over the age of 50) is marked by significant mental and physical changes. In addition, critical life events can occur, e.g. the loss of relatives, relationship problems, changes in the workplace, poverty, onset of disease. These changes can lead to a subsyndromal depressive disorder (subclinical depression), i.e., depressive symptoms are present, but not so strong as to justify the diagnosis of major depression. However, subclinical depression is very often associated with a poorer quality of life and mood.
The "horse-assisted biographical work" is an independent and as yet unpublished concept, which is composed of elements of horse-based interventions and biographical work (dealing with the life history of an individual). With the assistance of a horse, biographical topics are dealt with and the individual phases of development of the human being from childhood to adulthood are considered. The general research situation in the field of horse-assisted interventions is low; for horse-assisted biographical work, there is only one case study so far (see Schmidt, 2017).
The aim of this study is to investigate the efficacy of a preventive, horse-assisted, age-specific intervention for older subjects with subclinical depression.

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Brief Summary in Scientific Language

Multicentre, prospective, randomized, controlled, open efficacy study over eight weeks (90 minutes each session) with follow-up at 3 months.
The primary target is the BDI-II at posttest. The secondary outcomes are the BDI-II at follow-up and all other outcomes at both post-test and follow-up.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017010
  •   2019/04/01
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  •   yes
  •   Approved
  •   ER_11/2018, Rat für Ethik in der Forschung der Universität Siegen
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Secondary IDs

  •   U1111-1230-3988 
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Health Condition or Problem studied

  •   Subclinical depression
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Interventions/Observational Groups

  •   Subjects randomized to the intervention group will receive eight units of 90-minute PBA-E (horse-assisted biographical work) over a period of eight weeks. They are assessed for their mental status by means of a questionnaire battery immediately before the first and after the last intervention. During the intervention, short questionnaires are also collected. Three months after the last intervention, a follow-up assessment will be conducted.
  •   Subjects assigned to the control group initially participate in the pretest. After a waiting period of eight weeks, the posttest follows. After three months, the participants complete the follow-up test (identical to the posttest). As a motivation to participate, the study participants receive a three-session minimal intervention on the PBA-E.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Improvement of subclinical depression as measured by the Beck Depression Inventory - Revision (BDI-II), i.e., pre-post comparison between week 1 and week 8

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Secondary Outcome

BDI-II at follow-up as well as all other outcome measures (Mood Questionnaire - MDBF, questionnaire for recording positive and negative automatic thoughts - FAG, Beck Anxiety Inventory - BAI, Health questionnaire - SF-36, Gratitude Questionnaire - GQ-6, Reminiscence Functions Scale) RFS-28, General Self-Efficacy - SWE, Ego-Integrity - EI, Cognitive-Behavioral Avoidance Scale - KBVS) for both post-test and follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2019/06/30
  •   52
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Symptoms of subclinical depression (BDI-II ≥ 9);
Sufficient physical and mental capacity;
Sufficient language skills;
Signing the written declaration of consent for study participation after detailed information;
Note: Horse experience is not required

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Exclusion Criteria

Equinophobie;
Strong horse hair allergy;
Diagnosis of major depression after clinical interview (SCID-5);
Acute suicidality;
History of psychotic disorders;
History of dementia;
Anamnestic known severe systemic diseases;
Use of chemical or herbal antidepressants;
Participation in psychotherapeutic treatment 4 weeks before or during the study; Participation in another study within the last 30 days prior to inclusion;
Employment relationship with the principal investigator or one of the therapeutic cooperation partners;
Family relationship to the principal investigator or one of the therapeutic cooperation partners

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Addresses

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    • Universität Siegen, Institut für Psychologie
    • Mr.  Prof. Dr.  Simon  Forstmeier 
    • Adolf-Reichwein-Str. 2a
    • 57068  Siegen
    • Germany
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    • Universität Siegen, Institut für Psychologie
    • Mr.  Prof. Dr.  Simon  Forstmeier 
    • Adolf-Reichwein-Str. 2a
    • 57068  Siegen
    • Germany
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    • Universität Siegen und Reittherapie Wittgenstein
    • Ms.  Julia  Schmidt 
    • Pulvermühle 3
    • 57319  Bad Berleburg
    • Germany
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Sources of Monetary or Material Support

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    • BÖHL-Kunststofftechnik GmbH, Bad Berleburg; Breuer GmbH, Bad Laasphe; Bürgerstiftung Siegen, Siegen; Förderverein des Zentrums Therapeutisches Reiten Niederrhein e.v., Straelen; Friedhelm Loh Stiftung, Haiger; J.J. Darboven, Hamburg
    • Germany
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    • Universität Siegen, Institut für Psychologie
    • 57068  Siegen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/10/07
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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.