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

4. listopadu 2026 aktualizováno: 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".

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

128

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Canton of Zurich
      • Zurich, Canton of Zurich, Švýcarsko, 8032
        • Nábor
        • Psychiatric University Hospital Zurich
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Philipp Homan, Prof.
        • Dílčí vyšetřovatel:
          • Rahel Horisberger, Dr.phil.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from first session in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship
Časové okno: 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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Symptom Severity measured with the Positive and Negative Syndrome Scale
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Philipp Homan, Prof., University of Zurich

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. března 2023

Primární dokončení (Odhadovaný)

31. října 2027

Dokončení studie (Odhadovaný)

31. října 2027

Termíny zápisu do studia

První předloženo

2. května 2023

První předloženo, které splnilo kritéria kontroly kvality

9. června 2023

První zveřejněno (Aktuální)

22. června 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • MI for acute psychosis

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .