MIA: Motivational Interviewing for Patients With Acute Psychosis

Sponsor

Psychiatric University Hospital, Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT05911529

Collaborator

(none)

Enrollment

Location

Arms

8.5

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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, we want 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 our 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".

Condition or Disease	Intervention/Treatment	Phase
Psychosis Schizophrenia	Behavioral: Motivational Interviewing Behavioral: Supportive conversations	N/A

Detailed Description

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." (p.10). 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, we would like 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Motivational Interviewing for Patients With Acute Psychosis

Actual Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interviewing Group Patients will receive four sessions of Motivational Interviewing within two weeks.	Behavioral: Motivational Interviewing 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.
Active Comparator: Control Group Patients in the control group receive four sessions of supportive conversations within two weeks.	Behavioral: Supportive conversations 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).

Arm

Intervention/Treatment

Experimental: Motivational Interviewing Group

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

Behavioral: Motivational Interviewing

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.

Active Comparator: Control Group

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

Behavioral: Supportive conversations

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).

Outcome Measures

Primary Outcome Measures

Change from Baseline in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship [Baseline and week 3 (or after 4 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.
Change from Baseline in Treatment Adherence on the Brief Adherence Rating Scale [Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)]
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%).

Secondary Outcome Measures

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)]
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.
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)]
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.
Change from Baseline in Self-Efficacy on the General Self-Efficacy Scale [Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)]
Self-efficacy is measured with the german version of the General Self-Efficacy Scale (GSE), an instrument that has been proved with a sample of more than 19'000 persons in 25 countries and shows good psychometric properties.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 psychosis (F2.x)
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