Non-Pharmacological Treatment of Psychosis

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.

Study Overview

• Status: Recruiting
• Conditions: Psychosis; Schizophrenia-Like

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Erik Johnsen, PhD; Phone Number: 0047 55958400; Email: erik.johnsen@helse-bergen.no
• Study Contact Backup: Name: Lena Stabell, MSc; Phone Number: 0047 55958400; Email: lena.antonsen.stabell@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland Univsersity Hospital
    • Contact: Erik Johnsen, PhD; Phone Number: 0047 55958400; Email: erik.johnsen@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to remission	To investigate the time to remission (absence of positive psychotic symptoms as determined by the Positive And Negative Syndrome Scale)	One year
Time to recovery	To investigate the time to recovery (absence of positive psychotic symptoms plus normalized functioning)	One year
Time to relapse	To investigate the time to relapse (presence of positive psychotic symptoms)	One year
Insight	To investigate the change of insight as determined by Beck Cognitive Insight Scale (BCIS)	One year
Insight	To investigate the change of insight as determined by Medication Adherence Report Scale	One year
Insight	To investigate the change of insight as determined by Birchwood Insight Scale	One year

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 2018/938

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No