NCT05911529

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

May 2, 2023

Last Update Submit

July 12, 2024

Conditions

Keywords

PsychosisMotivational InterviewingPsychotherapy for psychosisAdherence to treatmentTherapeutic allianceAcute phase

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

EXPERIMENTAL

Patients will receive four sessions of Motivational Interviewing within two weeks.

Behavioral: Motivational Interviewing

Control Group

ACTIVE COMPARATOR

Patients in the control group receive four sessions of supportive conversations within two weeks.

Behavioral: Supportive conversations

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.

Motivational Interviewing Group

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).

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (24)

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    PMID: 17094819BACKGROUND
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    PMID: 3616518BACKGROUND
  • Byerly 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: 18255269BACKGROUND
  • Schwarzer, 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.

    BACKGROUND
  • Schulz, H., Nübling, R., & Rüddel, H. (1995). Entwicklung einer Kurzform eines Fragebogens zur Psychotherapiemotivation. Verhaltenstherapie, 5, 89-95.

    BACKGROUND
  • Aghotor 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: 20167306BACKGROUND
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    PMID: 12957702BACKGROUND
  • Cavelti 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: 27137967BACKGROUND
  • Galderisi 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: 33726883BACKGROUND
  • Grawe, K. (1995). Grundriss einer Allgemeinen Psychotherapie. Psychotherapeut, 40, 130-145.

    BACKGROUND
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    PMID: 27189524BACKGROUND
  • Kaiser, 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.

    BACKGROUND
  • Kennedy 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: 23995856BACKGROUND
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    PMID: 24523363BACKGROUND
  • Lincoln, 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

    BACKGROUND
  • Mehl, S., & Lincoln, T. (2014). Therapie-Tools Psychose. Beltz.

    BACKGROUND
  • Morrison 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: 21914252BACKGROUND
  • Morrison 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: 24508320BACKGROUND
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    PMID: 15207959BACKGROUND
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    BACKGROUND
  • National 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

    BACKGROUND
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    PMID: 26777917BACKGROUND
  • Puig 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: 25062593BACKGROUND
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    PMID: 22316568BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaTreatment Adherence and Compliance

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Philipp Homan, Prof.

    University of Zurich

    PRINCIPAL INVESTIGATOR

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

Locations