Efficacy of Equine Assisted Therapy on Negative Symptoms in Patients With Schizophrenia

NCT03935243 | Unknown

• 1 other identifier: 2019-STABLE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main object of this study is to evaluate the efficacy of equine assisted therapy on substantial and so far unsatisfactorily treatable symptom complexes in patients with schizophrenia.

Conditions

Animal Assisted Therapy

Outcome Measures

Primary Outcomes (2)

• Changed negative symptoms retrieved from psychometric instruments (BNSS) after the intervention

  BNSS: 5 domains for the negative symptoms are recorded, namely "blunted affect", "alogie", "asociality", "anhedonia" and "avolition". The BNSS also distinguishes between the anticipatory and the consumptive aspects of anhedonia, which are distinct advantages over other questionnaires such as PANSS or SANS (Kirkpatrick 2011, Marder \& Kirkpatrick 2014). With its 13 items that can be collected within 15 minutes, the BNSS is a short scale that, despite its shortness, has excellent inter-rater and test-retest reliability and good validity. Furthermore, there are only small correlations of the BNSS with masses of positive symptoms, anxiety and depression (Strauss et al., 2012, Kirkpatrick et al., 2011). Like the PSP scale, the BNSS is surveyed during the first, second and third rounds and here too the surveys are conducted by experienced psychologists or psychiatrists.

  week 0 (t1), week 8 +/- 1 day (t2), week 15 +/- 2 days (t3)

• Changed psychosocial functioning after the intervention (PSP)

  PSP: External rating scale consisting of 4 subscales, which are calculated to a total score ranging from 0 to 100. The 4 scales are "disturbing and aggressive behavior," "self-care," "socially beneficial activities," and "personal and social relationships" (Morosini et al., 2000). The individual items are queried on a 6-point scale, which includes the expressions "absent", "easy", "obvious", "pronounced", "severe" and "extremely serious". Explanations are available for the respective characteristics. Schaub and Juckel (2011) have also created an interview guide for the German version, which should further simplify the assessment. The individual surveys are carried out by experienced psychologists or psychiatrists. The PSP scale was chosen because it is quick and easy to query, has a higher information content than other scales (e.g., SOFAS or GAF), and also has high validity and reliability.

  week 0 (t1), week 8 +/- 1 day (t2), week 15 +/- 2 days (t3)

Secondary Outcomes (1)

• Changed quality of life (Quality of Life Questionnaire in Schizophrenia (S-QoL)

  week 0 (t1), week 8 +/- 1 day (t2), week 15 +/- 2 days (t3)

Study Arms (2)

equine assisted therapy

EXPERIMENTAL

In the active intervention phase, patients participate twice a week in a equine assisted group therapy, while during the control phase they participate twice a week in a group that includes a non-specific and general activity program. After 15 therapy units in a study phase, the subjects will complete the 15 units of the other study phase (within-subject-design). All participants complete both study phases, with the order being randomized.

Behavioral: equine assisted therapy

activating control phase

ACTIVE COMPARATOR

In the present study, the interventions in the control phase are based on the sub-program "Social Skills" of the Integrated Psychological Treatment Program (IPT) for schizophrenic patients (Brenner et al., 1994, Roder et al., 1988, 2002).

Behavioral: activating control phase

Interventions

equine assisted therapy BEHAVIORAL

The equine assisted group therapy is carried out by a riding therapist (nurse psychiatry HF, certified riding therapist SG-TR). There is a detailed plan for the PT.

equine assisted therapy

activating control phase BEHAVIORAL

The control phase includes a generally activating employment offer, such as board games, light physical activations, roundtables and artistic design.

activating control phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia (ICD-10: F20.0-20.3, F20.5)
• men or female patients (older than 18 years of age)
• written informed consent

You may not qualify if:

• acute risk of harming oneself or others
• severe manifest allergies
• medically uncontrolled epilepsy
• Significant side effects of medication (blood pressure fluctuations with dizziness, movement-limiting Parkinson's disease, etc.).

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, Switzerland

RECRUITING

Related Publications (21)

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  BACKGROUND

• Frith CD, Done DJ. Towards a neuropsychology of schizophrenia. Br J Psychiatry. 1988 Oct;153:437-43. doi: 10.1192/bjp.153.4.437.

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• Calvo P, Fortuny JR, Guzman S, Macias C, Bowen J, Garcia ML, Orejas O, Molins F, Tvarijonaviciute A, Ceron JJ, Bulbena A, Fatjo J. Animal Assisted Therapy (AAT) Program As a Useful Adjunct to Conventional Psychosocial Rehabilitation for Patients with Schizophrenia: Results of a Small-scale Randomized Controlled Trial. Front Psychol. 2016 May 6;7:631. doi: 10.3389/fpsyg.2016.00631. eCollection 2016.

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• Cerino S, Cirulli F, Chiarotti F, Seripa S. Non conventional psychiatric rehabilitation in schizophrenia using therapeutic riding: the FISE multicentre Pindar project. Ann Ist Super Sanita. 2011;47(4):409-14. doi: 10.4415/ANN_11_04_13.

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• Jormfeldt H, Carlsson IM. Equine-Assisted Therapeutic Interventions Among Individuals Diagnosed With Schizophrenia. A Systematic Review. Issues Ment Health Nurs. 2018 Aug;39(8):647-656. doi: 10.1080/01612840.2018.1440450. Epub 2018 Mar 6.

  PMID: 29509053 BACKGROUND

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  PMID: 20558531 BACKGROUND

• Marder SR, Kirkpatrick B. Defining and measuring negative symptoms of schizophrenia in clinical trials. Eur Neuropsychopharmacol. 2014 May;24(5):737-43. doi: 10.1016/j.euroneuro.2013.10.016. Epub 2013 Nov 11.

  PMID: 24275698 BACKGROUND

• Maujean, A., Pepping, C. A., & Kendall, E. (2015). A systematic review of randomized controlled trials of animal-assisted therapy on psychosocial outcomes. Anthrozoös, 28(1), 23-36. doi.org/10.2752/089279315X14129350721812

  BACKGROUND

• Rollnik JD, Huber TJ, Mogk H, Siggelkow S, Kropp S, Dengler R, Emrich HM, Schneider U. High frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex in schizophrenic patients. Neuroreport. 2000 Dec 18;11(18):4013-5. doi: 10.1097/00001756-200012180-00022.

  PMID: 11192620 BACKGROUND

• Schaub D, Juckel G. [PSP Scale: German version of the Personal and Social Performance Scale: valid instrument for the assessment of psychosocial functioning in the treatment of schizophrenia]. Nervenarzt. 2011 Sep;82(9):1178-84. doi: 10.1007/s00115-010-3204-4. German.

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• Villalta-Gil, V., Roca, M., Gonzalez, N., Domenec, E., Cuca, Escanilla, A., ... & Schi-Can group. (2009). Dog-assisted therapy in the treatment of chronic schizophrenia inpatients. Anthrozoös, 22(2), 149- 159. doi.org/10.2752/175303709X434176

  BACKGROUND

• Andreasen NC. The Scale for the Assessment of Negative Symptoms (SANS): conceptual and theoretical foundations. Br J Psychiatry Suppl. 1989 Nov;(7):49-58. No abstract available.

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• Auquier P, Simeoni MC, Sapin C, Reine G, Aghababian V, Cramer J, Lancon C. Development and validation of a patient-based health-related quality of life questionnaire in schizophrenia: the S-QoL. Schizophr Res. 2003 Sep 1;63(1-2):137-49. doi: 10.1016/s0920-9964(02)00355-9.

  PMID: 12892868 BACKGROUND

• Brenner, H. D., Roder, V., Hodel, B., Kienzle, N., Reed, D., & Liberman, R. P. (1994). Integrated psychological therapy for schizophrenic patients (IPT). Hogrefe & Huber Publishers.

  BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

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• Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9.

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  PMID: 23127378 BACKGROUND

MeSH Terms

Interventions

Equine-Assisted Therapy

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nathalie Brackmann, Dr. phil.

  University Hospital of Psychiatry Zurich, Department of Forensic Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Brackmann, Dr. phil.

CONTACT

+41 (0)52 304 93 01; nathalie.brackmann@puk.zh.ch

Carolin Opgen-Rhein, Dr. med.

CONTACT

carolin.opgen-rhein@puk.zh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 2, 2019
• Study Start: September 10, 2019
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)