Non-Pharmacological Treatment of Psychosis

NCT ID: NCT04051775

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-06-30

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.

Conditions

Psychosis; Schizophrenia-Like

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haukeland Univsersity Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Erik Johnsen, PhD

Role: CONTACT

erik.johnsen@helse-bergen.no

0047 55958400

Lena Stabell, MSc

Role: CONTACT

lena.antonsen.stabell@helse-bergen.no

0047 55958400

Facility Contacts

Erik Johnsen, PhD

Role: primary

erik.johnsen@helse-bergen.no

0047 55958400

Other Identifiers

2018/938

Identifier Type: -

Identifier Source: org_study_id