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

2026年11月4日 更新者: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".

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

128

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Canton of Zurich
      • Zurich、Canton of Zurich、スイス、8032
        • 募集
        • Psychiatric University Hospital Zurich
        • コンタクト:
        • 主任研究者:
          • Philipp Homan, Prof.
        • 副調査官:
          • Rahel Horisberger, Dr.phil.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from first session in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in Symptom Severity measured with the Positive and Negative Syndrome Scale
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Philipp Homan, Prof.、University of Zurich

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年3月15日

一次修了 (推定)

2027年10月31日

研究の完了 (推定)

2027年10月31日

試験登録日

最初に提出

2023年5月2日

QC基準を満たした最初の提出物

2023年6月9日

最初の投稿 (実際)

2023年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • MI for acute psychosis

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いいえ

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