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Tracking the Linguistic Signatures of Motivational Interviewing in Acute Psychosis (TRACK-MI)

4 de novembro de 2026 atualizado por: Rahel Horisberger, Psychiatric University Hospital, Zurich

Tracking the Linguistic Signatures of Motivational Interviewing in Acute Psychosis (Former: Motivational Interviewing for Patients With Acute Psychosis)

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".

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Psychotic disorders are among the top ten causes of long-term disability and have a high chronicity potential and a high risk of invalidity. One-fifth of all patients with schizophrenia suffer from chronic symptoms and impairments, and the disease is associated with low long-term work performance, a high degree of all mental health care resources and high socioeconomic costs. These findings demonstrate the importance of sufficient treatment for psychotic disorders and, most importantly, point to a need for research so that more effective treatments can be developed in the future.

In the recent decade, various psychotherapeutic programs with cognitive-behavioral background have been developed for patients with psychosis, and their efficacy has been investigated. Meta-analyses have shown superiority of cognitive-behavioral therapy for psychosis over standard treatment, both in combination with antipsychotic medication and without. Many of the psychological approaches have focused primarily on treating the deficits associated with psychosis, as for example cognitive remediation or social skills training. However, these methods are not feasible in the acute setting and there are only a few psychotherapeutic instruments that can be used within a short period of time for inpatient treatment.

The guidelines for the treatment of schizophrenia recommend a combination of antipsychotic medication and psychosis-specific cognitive behavioral therapy. This includes all stages of the illness, also in the acute phase. The Swiss Society for Psychiatry and Psychotherapy (SGPP) has stated in its treatment guidelines for schizophrenia that "our group recommends a structured psychotherapeutic approach even in the acute phase of the disease. The best evidence currently exists for cognitive-behavioral approaches, […]. In any case, the psychotherapeutic procedure must be adapted to the circumstances of the acute phase and there is an urgent need for research on how this can be arranged in the setting of an acute ward.". Despite this explicit recommendation, to our knowledge there have been no studies that have systematically investigated this in the acute setting and results of which could therefore inform future treatment recommendations. As proposed by the SGPP, the aim is to systematically test and evaluate psychotherapeutic interventions in the setting of an acute care unit in an initial pilot trial.

Therapeutic alliance during the acute phase of psychotic illness is one of the most pressing obstacles for successful long term recovery. In order for patients to accept much-needed medication and psychosocial therapy and not drop out prematurely, intrinsic motivation to adhere to therapy is crucial. Motivational Interviewing is a method, that has been developed and evaluated over the last three decades and that shows promising results, not only for patients with addiction but also for other patients who struggle with compliance and ambivalence towards treatment and change of behavior.

It is well known from clinical experience that patients are offered psychotherapy only late during the course of hospitalizations and not when it is highly needed - during the acute phase of their illness. Accordingly, there is a clear gap in the literature as to which interventions are particularly useful in this challenging yet crucial phase of the illness.

Tipo de estudo

Intervencional

Inscrição (Estimado)

128

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Canton of Zurich
      • Zurich, Canton of Zurich, Suíça, 8032
        • Recrutamento
        • Psychiatric University Hospital Zurich
        • Contato:
        • Investigador principal:
          • Philipp Homan, Prof.
        • Subinvestigador:
          • Rahel Horisberger, Dr.phil.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Informed consent as documented by signature
  • Male and female patients from inpatient units of the Psychiatric University Hospital of Zurich
  • ICD-10 diagnosis of a mental disorder with psychotic symptoms, including schizophrenia, schizotypal and delusional disorders (F20-F29), affective disorders with psychotic features (F30.2, F31.2, F31.5, F32.3, F33.3) and substance-induced psychotic disorders (F1x.5)
  • Fluent in German and able to understand the instructions

Exclusion Criteria:

  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Motivational Interviewing Group

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

In our study intervention, patients should receive three 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.

Comparador Ativo: Control Group

Patients in the control group receive three sessions of psychoeducation within two weeks.

In the control intervention patients should also be given three sessions, in which no MI techniques take place. They will be carried out in the form of psychoeducational interventions, which are part of a standard treatment program for patients with schizophrenia during the acute and post-acute phases. Psychoeducation aims to inform patients about their illness and its treatment, enhancing both the understanding and the personally responsible handling of the illness and supporting those afflicted in coping with the disorder. Since we want to check whether the patients really benefit from the specific intervention rather than from receiving additional contact time, the patient in the control group will also be given three sessions. It is known that psychoeducation can have a positive effect on treatment out come by reducing relapse rate and the frequency of rehospitalizations, improving treatment ad herence, and shortening the length of inpatient hospital stays.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from first session in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship
Prazo: First session and week 2 (or after 3 sessions of psychotherapeutic intervention)

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.

First session and week 2 (or after 3 sessions of psychotherapeutic intervention)
Change from Baseline in Treatment Adherence on the electronic patient records
Prazo: Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

Adherence to medication and therapy will be assessed using the electronic patient records before and after the study intervention or control intervention.

Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Symptom Severity measured with the Positive and Negative Syndrome Scale
Prazo: Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

Psychotic symptoms are assessed with the Positive and Negative Syndrome Scale (PANSS). This is a structured interview, which consists of four scales measuring positive and negative syndromes of schizophrenia, their differential, and general severity of illness.

Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)
Change from Baseline in Motivation for psychotherapy in the Questionnaire to measure the motivation for psychotherapy
Prazo: Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

Motivation for psychotherapy will be measured with the german version of the Questionnaire to measure the motivation for psychotherapy, a 4-point Likert-scale with 39 items.

Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)
Change from Baseline in readinesss to change using Questionnaire for Assessing Readiness for Change (FEVER)
Prazo: Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

Stages of change will be assessed using the German version of the University of Rhode Is land Change Assessment (URICA), namely the "Fragebogen zur Erfassung der Veränderungsbereitschaft" (FEVER). The instrument assesses temporal motivational processes of behavioral change and comprises four sub scales: precontemplation, contemplation, action, and maintenance. In the German adapta tion, the original 32-item version was reduced to 24 items by removing the eight items of the maintenance subscale. As the maintenance phase of the German questionnaire has not been validated, it will additionally be explored using four qualitative questions. All items are rated on a 5-point Likert scale. All subscales demonstrated good reliability and validity.

Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)
Change from Baseline in levels of risk to self or others measured with Short-Term Assessment of Risk and Treatability (START)
Prazo: Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

Levels of risk to self or others will be evaluated using the Short-Term Assessment of Risk and Treatability (START), a structured professional judgement instrument assessing multiple risk estimates relevant to acute psychiatric care. The instrument comprises 20 items that are evaluated in terms of both vulnerabilities (risk factors) and strengths (protective factors). Each item is rated separately on the vulnerability and strength scales using a 3-point Likert scale ranging from 0 (no/minimal) to 2 (high). Based on these ratings, structured risk estimates are provided across seven domains: violence, suicide, self-harm, substance abuse, unauthorized leave, self neglect, and victimization. It has demonstrated high interrater reliability, high internal consistency, convergent validity with other risk measures, strong predictive validity for various aggressive outcomes, and good predictive validity for self-harm.

Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)
Duration of involuntary admission
Prazo: Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)

The duration of involuntary admission will be assessed using electronic patient records.

Baseline and week 2 (or after 3 sessions of psychotherapeutic intervention)
Rehospitalisation
Prazo: Within 6 months after discharge

The occurrence of rehospitalisation will be assessed using electronic patient records.

Within 6 months after discharge
Communication patterns in dyadic patient clinician conversations
Prazo: During all three patient-clinician consultations conducted within one week

The communication patterns in dyadic patient clinician conversations assessed using computational linguistic analyses of speech data collected during the trial.

During all three patient-clinician consultations conducted within one week

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Philipp Homan, Prof., University of Zurich

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de março de 2023

Conclusão Primária (Estimado)

31 de outubro de 2027

Conclusão do estudo (Estimado)

31 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de maio de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de junho de 2023

Primeira postagem (Real)

22 de junho de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • MI for acute psychosis

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .