Motivational Interviewing for Patients With Acute Psychosis
MIA
1 other identifier
interventional
28
1 country
1
Brief Summary
Psychotic disorders are associated with high levels of distress, limitations in quality of life, and a high risk of chronification for those affected. The treatment guidelines recommend combining the pharmacological treatment with psychotherapeutic methods, starting already in the acute phase. At the same time, there is little research evidence on which mechanisms of psychotherapy are most effective and best feasible for the acute setting. Therefore, the aim is to run a pilot study to test specific psychotherapeutic interventions for patients with psychosis on acute psychiatric wards. The method of "Motivational Interviewing" is a well-known and established interviewing technique, which originally comes from the treatment of addictive disorders. In this study, it is used to strengthen the therapeutic alliance between patient and practitioner already in the acute phase of the disease, to increase adherence, and thus to achieve the overall goal of better integrating patients with pronounced positive symptoms into treatment. This appears to be extremely important, as non-adherence represents one of the greatest risks for chronification of the disease. The intervention will subsequently be evaluated in comparison to "treatment as usual".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 16, 2024
July 1, 2024
10 months
May 2, 2023
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship
The therapeutic relationship will be evaluated with the german version of the Scale to Assess Therapeutic Relationship (STAR). The patient (STAR-P) and clinician scales (STAR-C) each have 12 items comprising three subscales: positive collaboration and posi-tive clinician input in both versions, non-supportive clinician input in the patient version, and emotional difficulties in the clinician version.
Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Change from Baseline in Treatment Adherence on the Brief Adherence Rating Scale
The Brief Adherence Rating Scale (BARS) is a brief, pencil-paper, clinician-administered adherence assessment instrument. It consists of 4 items: 3 questions and an overall visual analog rating scale to assess the proportion of doses taken by the patient in the past month (0%-100%).
Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Secondary Outcomes (3)
Change from Baseline in Symptom Severity measured with the Positive and Negative Syndrome Scale
Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Change from Baseline in Motivation for psychotherapy in the Questionnaire to measure the motivation for psychotherapy
Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Change from Baseline in Self-Efficacy on the General Self-Efficacy Scale
Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Study Arms (2)
Motivational Interviewing Group
EXPERIMENTALPatients will receive four sessions of Motivational Interviewing within two weeks.
Control Group
ACTIVE COMPARATORPatients in the control group receive four sessions of supportive conversations within two weeks.
Interventions
In our study intervention, patients should receive four session of motivational interviewing (MI). Throughout the MI sessions, interviewers use common MI techniques including open-ended questions, affirmations, reflections, summaries, asking permission, expressing empathy, supporting self-efficacy, etc. Interviewers are clinical psychologists who received MI training immediately prior to the study.
In the control intervention patients should also be given four sessions, in which no MI techniques take place. They will be carried out in the sense of supportive conversations (i. e. conver-sations that do not follow a specific psychotherapy concept). Since we want to check whether the patients really benefit from the specific intervention and not from getting more speaking time, the patient in the control group will also be given four conver-sations. It is known that supportive conversations can have a certain effect on the well-being and recovery process of patients, as the therapeutic relationship, i.e. appreciation, attention and/or attention, is an important efficacy factor (e. g. Grawe, 1995).
Eligibility Criteria
You may qualify if:
- Informed consent as documented by signature
- Male and female patients from inpatient units of the Psychiatric University Hospital of Zurich
- ICD-10 diagnosis of psychosis (F2.x)
- Fluent in German and able to understand the instructions
You may not qualify if:
- Organic schizophrenia-like disorder (ICD: F0.6)
- Drug or alcohol abuse during treatment
- Previous enrolment in the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- During study: Complete stop of taking antipsychotic medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric University Hospital Zurich
Zurich, 8032, Switzerland
Related Publications (24)
McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
PMID: 17094819BACKGROUNDKay 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.
PMID: 3616518BACKGROUNDByerly MJ, Nakonezny PA, Rush AJ. The Brief Adherence Rating Scale (BARS) validated against electronic monitoring in assessing the antipsychotic medication adherence of outpatients with schizophrenia and schizoaffective disorder. Schizophr Res. 2008 Mar;100(1-3):60-9. doi: 10.1016/j.schres.2007.12.470. Epub 2008 Feb 5.
PMID: 18255269BACKGROUNDSchwarzer, R., & Jerusalem, M. (1995). Generalized self-efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio causal and control beliefs. (pp. 35-37). NFER-NELSON.
BACKGROUNDSchulz, H., Nübling, R., & Rüddel, H. (1995). Entwicklung einer Kurzform eines Fragebogens zur Psychotherapiemotivation. Verhaltenstherapie, 5, 89-95.
BACKGROUNDAghotor J, Pfueller U, Moritz S, Weisbrod M, Roesch-Ely D. Metacognitive training for patients with schizophrenia (MCT): feasibility and preliminary evidence for its efficacy. J Behav Ther Exp Psychiatry. 2010 Sep;41(3):207-11. doi: 10.1016/j.jbtep.2010.01.004. Epub 2010 Jan 28.
PMID: 20167306BACKGROUNDBark N, Revheim N, Huq F, Khalderov V, Ganz ZW, Medalia A. The impact of cognitive remediation on psychiatric symptoms of schizophrenia. Schizophr Res. 2003 Oct 1;63(3):229-35. doi: 10.1016/s0920-9964(02)00374-2.
PMID: 12957702BACKGROUNDCavelti M, Homan P, Vauth R. The impact of thought disorder on therapeutic alliance and personal recovery in schizophrenia and schizoaffective disorder: An exploratory study. Psychiatry Res. 2016 May 30;239:92-8. doi: 10.1016/j.psychres.2016.02.070. Epub 2016 Mar 2.
PMID: 27137967BACKGROUNDGalderisi S, Kaiser S, Bitter I, Nordentoft M, Mucci A, Sabe M, Giordano GM, Nielsen MO, Glenthoj LB, Pezzella P, Falkai P, Dollfus S, Gaebel W. EPA guidance on treatment of negative symptoms in schizophrenia. Eur Psychiatry. 2021 Mar 17;64(1):e21. doi: 10.1192/j.eurpsy.2021.13.
PMID: 33726883BACKGROUNDGrawe, K. (1995). Grundriss einer Allgemeinen Psychotherapie. Psychotherapeut, 40, 130-145.
BACKGROUNDKahn RS, Sommer IE, Murray RM, Meyer-Lindenberg A, Weinberger DR, Cannon TD, O'Donovan M, Correll CU, Kane JM, van Os J, Insel TR. Schizophrenia. Nat Rev Dis Primers. 2015 Nov 12;1:15067. doi: 10.1038/nrdp.2015.67.
PMID: 27189524BACKGROUNDKaiser, S., Berger, G., Conus, P., Kawohl, W., Müller, T. J., Schimmelmann, B. G., Traber, R., Trächsel, N., Vauth, R., & Seifritz, E. (2016). SGPP Behandlungsempfehlungen Schizophrenie. Schweizerische Gesellschaft für Psychiatrie und Psychotherapie.
BACKGROUNDKennedy JL, Altar CA, Taylor DL, Degtiar I, Hornberger JC. The social and economic burden of treatment-resistant schizophrenia: a systematic literature review. Int Clin Psychopharmacol. 2014 Mar;29(2):63-76. doi: 10.1097/YIC.0b013e32836508e6.
PMID: 23995856BACKGROUNDKuipers E, Yesufu-Udechuku A, Taylor C, Kendall T. Management of psychosis and schizophrenia in adults: summary of updated NICE guidance. BMJ. 2014 Feb 12;348:g1173. doi: 10.1136/bmj.g1173. No abstract available.
PMID: 24523363BACKGROUNDLincoln, T. M., & Pedersen, A. (2019). An Overview of the Evidence for Psychological Interventions for Psychosis: Results From Meta-Analyses. Clinical Psychology in Europe, 1(1), 1-23. https://doi.org/10.32872/cpe.v1i1.31407
BACKGROUNDMehl, S., & Lincoln, T. (2014). Therapie-Tools Psychose. Beltz.
BACKGROUNDMorrison AP, Hutton P, Wardle M, Spencer H, Barratt S, Brabban A, Callcott P, Christodoulides T, Dudley R, French P, Lumley V, Tai SJ, Turkington D. Cognitive therapy for people with a schizophrenia spectrum diagnosis not taking antipsychotic medication: an exploratory trial. Psychol Med. 2012 May;42(5):1049-56. doi: 10.1017/S0033291711001899. Epub 2011 Sep 14.
PMID: 21914252BACKGROUNDMorrison AP, Turkington D, Pyle M, Spencer H, Brabban A, Dunn G, Christodoulides T, Dudley R, Chapman N, Callcott P, Grace T, Lumley V, Drage L, Tully S, Irving K, Cummings A, Byrne R, Davies LM, Hutton P. Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial. Lancet. 2014 Apr 19;383(9926):1395-403. doi: 10.1016/S0140-6736(13)62246-1. Epub 2014 Feb 6.
PMID: 24508320BACKGROUNDMueser KT, McGurk SR. Schizophrenia. Lancet. 2004 Jun 19;363(9426):2063-72. doi: 10.1016/S0140-6736(04)16458-1.
PMID: 15207959BACKGROUNDMurray, C. J. L., & Lopez, A. D. (1996). The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020.
BACKGROUNDNational Institute for Health and Clinical Excellence (2010). Schizophrenia: The NICE Guideline on Core Interventions in the Treatment and Management of Schizophrenia in Adults in Primary and Secondary Care. http://www.nice.org.uk/nicemedia/pdf/CG82FullGuideline.pdf
BACKGROUNDOwen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. 2016 Jul 2;388(10039):86-97. doi: 10.1016/S0140-6736(15)01121-6. Epub 2016 Jan 15.
PMID: 26777917BACKGROUNDPuig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.
PMID: 25062593BACKGROUNDRabinowitz J, Levine SZ, Garibaldi G, Bugarski-Kirola D, Berardo CG, Kapur S. Negative symptoms have greater impact on functioning than positive symptoms in schizophrenia: analysis of CATIE data. Schizophr Res. 2012 May;137(1-3):147-50. doi: 10.1016/j.schres.2012.01.015. Epub 2012 Feb 6.
PMID: 22316568BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Homan, Prof.
University of Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical psychologist, PhD
Study Record Dates
First Submitted
May 2, 2023
First Posted
June 22, 2023
Study Start
March 15, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 16, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share