Clinical trial NCT04051775: Non-Pharmacological Treatment of Psychosis
Official title: Non-Pharmacological Treatment of Psychosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychosis; Schizophrenia-Like
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Exclusion Criteria Not fullfilling inclusion criteria

Primary outcomes:
measure: Serious adverse events
timeFrame: One year
Secondary outcomes:
measure: Time to remission
timeFrame: One year
measure: Time to recovery
timeFrame: One year
measure: Time to relapse
timeFrame: One year
measure: Insight
timeFrame: One year
measure: Insight
timeFrame: One year
measure: Insight
timeFrame: One year
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland Univsersity Hospital
Study officials:
References: