Non-Pharmacological Treatment of Psychosis

• ClinicalTrials.gov Identifier: NCT04051775
• Recruitment Status: Recruiting
• First Posted: August 9, 2019
• Last Update Posted: August 3, 2022
• Sponsor: Haukeland University Hospital
• Information provided by (Responsible Party): Haukeland University Hospital

Study Description

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

Study Design

• 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, 2023
• Estimated Study Completion Date: June 30, 2023

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Erik Johnsen, PhD; 0047 55958400; erik.johnsen@helse-bergen.no

Contact: Lena Stabell, MSc; 0047 55958400; lena.antonsen.stabell@helse-bergen.no

Locations

Norway

Haukeland Univsersity Hospital; Recruiting

Bergen, Norway, 5021

Contact: Erik Johnsen, PhD 0047 55958400 erik.johnsen@helse-bergen.no

Sponsors and Collaborators

Haukeland University Hospital

More Information

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT04051775
• Other Study ID Numbers: 2018/938
• First Posted: August 9, 2019
• Last Update Posted: August 3, 2022
• Last Verified: July 2022

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

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders