PsychosisMIANCT05911529
Motivational Interviewing for Patients With Acute Psychosis
A study testing Motivational Interviewing and Supportive conversations in people with Psychosis and Schizophrenia, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Schizophrenia
- What is being tested?
- Motivational Interviewing and Supportive conversations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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".
Read the 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.". 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.
- Conditions
- Psychosis, Schizophrenia
- Being tested
- Motivational Interviewing, Supportive conversations
- Keywords
- Psychosis, Motivational Interviewing, Psychotherapy for psychosis, Adherence to treatment, Therapeutic alliance, Acute phase
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Supportive conversationsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Group | Experimental | Patients will receive four sessions of Motivational Interviewing within two weeks. Receives: Behavioral: Motivational Interviewing |
| Control Group | Active comparator | Patients in the control group receive four sessions of supportive conversations within two weeks. Receives: Behavioral: Supportive conversations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%).
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Change from Baseline in Self-Efficacy on the General Self-Efficacy Scale
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.
Measured: Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahel Horisberger, Psychiatric University Hospital, Zurich
- Investigators
- Philipp Homan, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911529
- Sponsor's protocol ID
- MI for acute psychosis
- Acronym
- MIA
- Status last verified
- Jul 2024
- First submitted
- 2 May 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
PubMed 17094819Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518Byerly 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.
PubMed 18255269Schwarzer, 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.
Schulz, H., Nübling, R., & Rüddel, H. (1995). Entwicklung einer Kurzform eines Fragebogens zur Psychotherapiemotivation. Verhaltenstherapie, 5, 89-95.
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.
PubMed 20167306Bark N, Revheim N, Huq F, Khalderov V, Ganz ZW, Medalia A. The impact of cognitive remediation on psychiatric symptoms of schizophrenia. Schizophr Res. 2003 Oct 1;63(3):229-35. doi: 10.1016/s0920-9964(02)00374-2.
PubMed 12957702Cavelti 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.
PubMed 27137967Galderisi 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.
PubMed 33726883Grawe, K. (1995). Grundriss einer Allgemeinen Psychotherapie. Psychotherapeut, 40, 130-145.
Kahn RS, Sommer IE, Murray RM, Meyer-Lindenberg A, Weinberger DR, Cannon TD, O'Donovan M, Correll CU, Kane JM, van Os J, Insel TR. Schizophrenia. Nat Rev Dis Primers. 2015 Nov 12;1:15067. doi: 10.1038/nrdp.2015.67.
PubMed 27189524Kaiser, 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.
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.
PubMed 23995856Kuipers E, Yesufu-Udechuku A, Taylor C, Kendall T. Management of psychosis and schizophrenia in adults: summary of updated NICE guidance. BMJ. 2014 Feb 12;348:g1173. doi: 10.1136/bmj.g1173. No abstract available.
PubMed 24523363Lincoln, 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing for Patients With Acute Psychosis
- ClinicalTrials.gov ID
- NCT05911529
- Acronym / sponsor ID
- MIA / MI for acute psychosis
- Conditions
- Psychosis, Schizophrenia
- Keywords
- Psychosis, Motivational Interviewing, Psychotherapy for psychosis, Adherence to treatment, Therapeutic alliance, Acute phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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.". 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Group | Experimental | Behavioral: Motivational InterviewingPatients will receive four sessions of Motivational Interviewing within two weeks. |
| Control Group | Active comparator | Behavioral: Supportive conversationsPatients in the control group receive four sessions of supportive conversations within two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingIn 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. | Behavioural | Motivational Interviewing Group |
| Supportive conversationsIn 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). | Behavioural | Control Group |
Primary outcome
Change from Baseline in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship
Time frame: 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
Time frame: 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%).
3 secondary outcomes
Change from Baseline in Symptom Severity measured with the Positive and Negative Syndrome Scale
Time frame: 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
Time frame: Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Change from Baseline in Self-Efficacy on the General Self-Efficacy Scale
Time frame: Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 17094819McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
- Background: PubMed 3616518Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
- Background: PubMed 18255269Byerly 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.
- BackgroundSchwarzer, 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.
- BackgroundSchulz, H., Nübling, R., & Rüddel, H. (1995). Entwicklung einer Kurzform eines Fragebogens zur Psychotherapiemotivation. Verhaltenstherapie, 5, 89-95.
- Background: PubMed 20167306Aghotor 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.
- Background: PubMed 12957702Bark N, Revheim N, Huq F, Khalderov V, Ganz ZW, Medalia A. The impact of cognitive remediation on psychiatric symptoms of schizophrenia. Schizophr Res. 2003 Oct 1;63(3):229-35. doi: 10.1016/s0920-9964(02)00374-2.
- Background: PubMed 27137967Cavelti 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.
- Background: PubMed 33726883Galderisi 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.
- BackgroundGrawe, K. (1995). Grundriss einer Allgemeinen Psychotherapie. Psychotherapeut, 40, 130-145.
- Background: PubMed 27189524Kahn RS, Sommer IE, Murray RM, Meyer-Lindenberg A, Weinberger DR, Cannon TD, O'Donovan M, Correll CU, Kane JM, van Os J, Insel TR. Schizophrenia. Nat Rev Dis Primers. 2015 Nov 12;1:15067. doi: 10.1038/nrdp.2015.67.
- BackgroundKaiser, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Homan, Prof. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Supportive conversations in people with Psychosis and Schizophrenia, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship (time frame: Baseline and week 3 (or after 4 sessions of psychotherapeutic intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911529, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.