|Age:||12 to 25 years old|
|Keywords:||psychosis, early psychosis, early intervention in psychosis, high risk psychosis|
|Type:||Behavioral study, Phase 3|
If you are determined to be eligible for the study, there will also be some physical measurements taken at this visit. The initial screening assessment will take between one and three hours depending on which of these assessments you give consent to. The screening assessment can take place over a few sessions to meet your preferences.
During Step 1, you will receive a psychological intervention called “Support and Problem Solving” (SPS) over a six-week period. Support and Problem Solving involves a therapist providing you with emotional support, and helping you to resolve problems with your day-to-day life. You will attend multiple SPS sessions (each approximately 30-50 minutes in duration) during this study step. The number of SPS sessions you receive will vary depending on your needs and what your clinician feels is appropriate for you.
If your symptoms do improve in response to Step 1, you will be randomly allocated to one of two treatment groups:
EITHER (1) Monthly Support and Problem Solving sessions for up to one year, with follow-up research assessments at Month 3, Month 6, Month 9 and Month 12. OR (2) Three-monthly monitoring by research study staff i.e. research study staff will interview you in order to assess your mental state, with follow-up research assessments at Month 3, Month 6, Month 9 and Month 12.
If your symptoms do not improve in response to Step 1, you will continue through to the second step of this study, Step 2.
If you continue through to Step 2, you will be randomly allocated to one of two treatment groups:
EITHER (1) Support and Problem Solving (the same therapy you received during Step 1). OR (2) Cognitive Behavioral Case Management (CBCM).
Cognitive Behavioral Case Management has a number of different elements, including strategies to help you manage stress, therapy that targets thinking and behavioral patterns, practical assistance, as well as yoga and mindfulness.
If your symptoms do improve in response to the treatment you received during Step 2, you will be randomly assigned to one of two treatment groups:
EITHER (1) Monthly Support and Problem Solving sessions for a further six months. OR (2) Three-monthly monitoring by research study staff, i.e. research study staff will interview you to assess your mental state every three months for a further six months.
If your symptoms do not improve in response to the treatment you received during Step 2, you will continue through to the third step of this study, Step 3.
If you continue through to Step 3, you will first have a blood sample collected for clinical safety testing to confirm that it is safe for you to proceed with medication. Where applicable, female participants might also need to have a blood sample taken for a pregnancy test before they can start this study step.
Once the tests confirm it is safe for you to proceed with Step 3, you will be randomized to one of two treatment groups:
EITHER (1) Cognitive Behavioral Case Management plus an antidepressant medication (fluoxetine). OR (2) Cognitive Behavioral Case Management plus a placebo medication.
The antidepressant medication will be fluoxetine (20-40mg/day), to be taken each morning with fluid (20mg = one capsule). A placebo is a capsule that looks like the study treatment but which does not contain any active ingredients.
If your symptoms do not improve or deteriorate by 12 weeks into Step 3, you will be given a choice of one of the following:
A participant will be considered eligible for inclusion in this study only if all of the following criteria apply:
Age 12 – 30 years (inclusive) at entry
Previous or current SCID diagnosis of bipolar disorder I.
Previous or current use of antipsychotic or antidepressant medication is not an exclusion criterion. In the case of current antipsychotic or antidepressant use, we will taper and cease this at entry to the study. This is consistent with clinical guidelines because antipsychotics are not indicated for the UHR population (147, 148) and antidepressants in young people are recommended only for those with severe depression, with psychosocial interventions recommended for those with mild-moderate depression (149). Most UHR cases who suffer from depression have mild-moderate rather than severe depression (143, 150). If they develop severe depression during the course of the study they are likely to meet the discontinuation criterion of risk to self and be commenced on antidepressant medication.
It is important to note that while these medications are not specifically indicated for use in this population, there have been a number of studies (e.g. 38, 39) that have highlighted the benefit of antidepressants. Antidepressants could reduce risk by improving mood and thereby indirectly reducing faulty appraisal of anomalous experiences linked to future psychosis. Alternatively, they may modulate response to environmental stress and adversity, which has been found to increase risk for psychosis (41).
In Steps 1 and 2 antidepressants will not be permitted. The use of antipsychotics or mood stabilizers is not permitted for the duration of the study except as described in the fast fail section (24 months). Young people seeking help via the EDAPT clinic are routinely screened using the SCID, and as clinically appropriate, an additional screening tool will be used by clinicians which will help them determine the UHR status of their clients. This tool is the Prodromal Questionnaire-Brief (PQ-B)(144). Those who score 6 or more positive symptoms on the PQ-B will be assessed using the SIPS, SOFAS, Global Assessment of Functioning-Modified (GAF-M) and Global Functioning: Social and Role Scales to determine UHR status. A cut-off score of 6 on the PQ-B screening tool has previously been found to identify UHR+ cases with high sensitivity (87%) and specificity (87%) (144) and has also been found to identify a more enriched sample for psychosis risk (146).
No pregnant women or prisoners will be included.
Only participants who meet all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.
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