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Baseline data of a sequential multiple assignment randomized trial (STEP study)
- Source :
- Early intervention in psychiatry, vol 16, iss 10
- Publication Year :
- 2022
- Publisher :
- eScholarship, University of California, 2022.
-
Abstract
- AimResearch has shown that preventative intervention in individuals at ultra-high risk of psychosis (UHR) improves symptomatic and functional outcomes. The staged treatment in early psychosis (STEP) trial aims to determine the most effective type, timing and sequence of interventions in the UHR population by sequentially studying the effectiveness of (1) support and problem solving, (2) cognitive-behavioural case management and (3) antidepressant medication with an embedded fast-fail option of (4) omega-3 fatty acids or low-dose antipsychotic medication. This paper presents the recruitment flow and baseline clinical characteristics of the sample.MethodsSTEP is a sequential multiple assignment randomized trial. We present the baseline demographics, clinical characteristics and acceptability and feasibility of this treatment approach as indicated by the flow of participants from first contact up until enrolment into the trial. Recruitment took place between April 2016 and January 2019.ResultsOf 1343, help-seeking young people who were considered for participation, 402 participants were not eligible and 599 declined/disengaged, resulting in a total of 342 participants enrolled in the study. The most common reason for exclusion was an active prescription of antidepressant medication. Eighty-five percent of the enrolled sample had a non-psychotic DSM-5 diagnosis and symptomatic/functional measures showed a moderate level of clinical severity and functional impairment.DiscussionThe present study demonstrates the acceptability and participant's general positive appraisal of sequential treatment. It also shows, in line with other trials in UHR individuals, a significant level of psychiatric morbidity and impairment, demonstrating the clear need for care in this group and that treatment is appropriate.
- Subjects :
- Adolescent
Clinical Trials and Supportive Activities
Clinical Sciences
ultra-high risk
Clinical Research
Humans
Psychology
psychosis
Biological Psychiatry
Omega-3
Psychiatry
Prevention
Fatty Acids
Evaluation of treatments and therapeutic interventions
clinical trial
antidepressant medication
Antidepressive Agents
prodrome
Brain Disorders
Diagnostic and Statistical Manual of Mental Disorders
Psychiatry and Mental health
Mental Health
Psychotic Disorders
6.1 Pharmaceuticals
Pshychiatric Mental Health
Antipsychotic Agents
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Early intervention in psychiatry, vol 16, iss 10
- Accession number :
- edsair.doi.dedup.....25e927b30275405ae7ca6b799ebd7a62