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Non-Pharmacological Treatment of Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04051775
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
The objectives of the project are to investigate feasibility, safety, and health-related outcomes in patients with psychosis who choose not to use antipsychotic drugs (APs). The instruction from the Ministry of Health and Care Services to establish "Medication Free" (non-pharmacological (NonPharm)) treatment services, which has received substantial critique for being given without support in scientific evidence, provides a window of opportunity for research in an under-investigated field. The study will prospectively follow a cohort over 1 year who seeks NonPharm treatment, with repeated measurements of symptoms, functional outcomes, quality of life, adverse events, as well as biological parameters including genetics and brain imaging, and environmental factors, and compare the findings to a control group of users of antipsychotic drugs, matched for age, gender and diagnosis. Current unanswered questions in the treatment of psychosis include which patients can successfully and safely discontinue antipsychotic medication; and what are the long-term symptomatic, biological and functional outcomes after use or non-use of APs, respectively. Taken together there is a fundamental lack of high-quality evidence to guide the treatment options in people who cannot or do not want to use APs in psychosis. This is also a major challenge in the study, as a more rigorous design that could directly compare different treatment options is not feasible, because no alternatives to APs have proven to be sufficiently effective and safe in controlled trials. The study is accordingly expected to provide new exploratory information that could be the basis of intervention studies which in its turn could provide important information for consumers and the mental health services regarding treatment options in psychosis.

Condition or disease
Psychosis; Schizophrenia-Like

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Pharmacological Treatment of Psychosis
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Serious adverse events [ Time Frame: One year ]
    To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group

Secondary Outcome Measures :
  1. Time to remission [ Time Frame: One year ]
    To investigate the time to remission (absence of positive psychotic symptoms as determined by the Positive And Negative Syndrome Scale)

  2. Time to recovery [ Time Frame: One year ]
    To investigate the time to recovery (absence of positive psychotic symptoms plus normalized functioning)

  3. Time to relapse [ Time Frame: One year ]
    To investigate the time to relapse (presence of positive psychotic symptoms)

  4. Insight [ Time Frame: One year ]
    To investigate the change of insight as determined by Beck Cognitive Insight Scale (BCIS)

  5. Insight [ Time Frame: One year ]
    To investigate the change of insight as determined by Medication Adherence Report Scale

  6. Insight [ Time Frame: One year ]
    To investigate the change of insight as determined by Birchwood Insight Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible patients are those seeking NonPharm treatment who has a diagnosis of schizophrenia or related disorder (corresponding to chapter F2 in the ICD-10). Eligible patients will be included from the Division of Psychiatry, Haukeland University Hospital and collaborating District Psychiatric Centers in the same catchment area. The catchment population is 400.000. Both in- and out-patients are eligible for the study.

Inclusion Criteria:

  • Fulfillment of diagnostic criteria for schizophrenia or related disorder (corresponding to chapter F2 in the ICD-10)
  • The clinician responsible for the treatment must consider nonpharmacological treatment to be professionally justifiable in the patient in question
  • Patient being able/ capable of providing informed consent
  • Patient receiving active treatment including different psychosocial treatments
  • Patient having a treatment plan and a crisis resolution plan.

Exclusion Criteria Not fullfilling inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04051775

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Contact: Erik Johnsen, PhD 0047 55958400
Contact: Lena Stabell, MSc 0047 55958400

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Haukeland Univsersity Hospital Recruiting
Bergen, Norway, 5021
Contact: Erik Johnsen, PhD    0047 55958400   
Sponsors and Collaborators
Haukeland University Hospital

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Responsible Party: Haukeland University Hospital Identifier: NCT04051775     History of Changes
Other Study ID Numbers: 2018/938
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders