Managing adolescent first episode psychosis: a feasibility study

Conditions

Specialty: Mental Health, Primary sub-specialty: Psychosis

Anthony P. Morrison, Melissa Pyle, Rory Byrne, Matthew R. Broome, Daniel Freeman et al. (21 authors)

Health Technology Assessment2021-01-0112 citations

Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.

Morrison AP, Pyle M, Maughan D, Johns L, Freeman D, Broome MR, Husain N, Fowler D, Hudson J, MacLennan G, Norrie J, Shiers D, Hollis C, James A, MAPS group.

2020-07-0742 citations

10.1016/s2215-0366(20)30248-0

Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14–18-year-olds: Managing Adolescent first episode Psychosis: a feasibility study (MAPS)

Melissa Pyle, Matthew R. Broome, Emmeline Joyce, Graeme MacLennan, John Norrie et al. (22 authors)

Trials2019-07-0411 citations

10.1186/s13063-019-3506-1

Interventions

Randomisation will be in the ratio 1:1:1 to the three groups and will be stratified by site and family contact (since participants who do not have regular contact with their families will not receive

the responsible consultant psychiatrists will choose the individual AP. The choice of antipsychotic medication should be made jointly with the young person and their parents or carers, and healthcare

however, they will be free to change dose and type of antipsychotic in response to monitoring of efficacy and adverse effects, which is consistent with current NICE guidelines. 3. Comb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 14-18 (to ensure adolescent status) 2. In contact with Early Intervention Services/Child and Adolescent Mental Health Services (to ensure appropriate safety considerations can be implemented) 3. Competent to provide written, informed consent, with additional parental consent for those aged < 16 (for ethical considerations). 4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) to allow for diagnostic uncertainty in early phases of psychosis 5. Within 1 year of onset of psychosis (to ensure first episode status) 6. Score 4+ on Positive and Negative Syndrome Scale (PANSS) delusions or hallucinations [for a minimum duration of seven consecutive days] (to ensure current psychosis) 7. Help-seeking (for ethical considerations)

Exclusion criteria

Exclusion criteria: 1. A primary diagnosis of alcohol/substance dependence * 2. A diagnosis of moderate or severe learning disability * 3. A diagnosis of ICD-10 organic psychosis * 4. Score 5+ on PANSS conceptual disorganisation / disorganised speech (since majority of participants will be randomised to a talking therapy, we require capacity to answer questions in an interview situation and engage in a conversation) 5. Non-English speaking (since majority of participants will be randomised to a talking therapy) 6. Received APs or structured PI within the last 3 months (to ensure treatment naivety) 7. Immediate risk to self or others (to ensure appropriate safety considerations can be addressed) * These exclusions are to ensure that the participant population are representative of young people with a primary problem of first episode psychosis

Design outcomes

Primary

Measure	Time frame
Primary outcome measures as of 09/10/2018: As this is a feasibility trial, a single primary outcome is not meaningful and the key outcomes to inform a future trial are: 1. Referral rates and recruitment rates, assessed at the end of the recruitment window in October 2018 2. Attendance at therapy sessions, compliance with medication and follow-up and questionnaire response rates, assessed at the end of the follow-up window in April 2019 3. Acceptability of treatment, measured using rates of drop-out from treatment at the end of the follow-up window by April 2019 Measurement of feasibility success criteria: i) Recruitment =80% of planned (green), recruitment within 79 -60% of planned (amber), recruitment < 60% of planned (red). ii) Retention of participants within the study with baseline and outcome assessments at primary end point (6 months, end of treatment) =80% of primary outcome completed (green), 79 -60% of primary outcome completed (amber), < 60% of primary outcome completed (red). iii) Satisfactory delivery of adherent therapy to =80% of groups receiving PI (green), 79-60% of groups receiving PI (amber), < 60% of groups receiving PI (red). Satisfactory delivery of adherent therapy will be operationalised as attending 6 or more sessions of CBT. iv) Satisfactory delivery of antipsychotic medication to =80% of groups receiving AP (green), 79-60% of groups receiving AP (amber), < 60% of groups receiving AP (red). Satisfactory delivery of antipsychotic medication will be operationalised as any exposure of AP for 6 consecutive weeks (this would include a dose below BNF lower limits given this is a frequent clinical practice for people of this age and the drugs are licensed for adults). Primary outcome measure as of 03/08/2018: As this is a feasibility trial, a single primary outcome is n	—

Measure

Time frame

Primary outcome measures as of 09/10/2018: As this is a feasibility trial, a single primary outcome is not meaningful and the key outcomes to inform a future trial are: 1. Referral rates and recruitment rates, assessed at the end of the recruitment window in October 2018 2. Attendance at therapy sessions, compliance with medication and follow-up and questionnaire response rates, assessed at the end of the follow-up window in April 2019 3. Acceptability of treatment, measured using rates of drop-out from treatment at the end of the follow-up window by April 2019 Measurement of feasibility success criteria: i) Recruitment =80% of planned (green), recruitment within 79 -60% of planned (amber), recruitment < 60% of planned (red). ii) Retention of participants within the study with baseline and outcome assessments at primary end point (6 months, end of treatment) =80% of primary outcome completed (green), 79 -60% of primary outcome completed (amber), < 60% of primary outcome completed (red). iii) Satisfactory delivery of adherent therapy to =80% of groups receiving PI (green), 79-60% of groups receiving PI (amber), < 60% of groups receiving PI (red). Satisfactory delivery of adherent therapy will be operationalised as attending 6 or more sessions of CBT. iv) Satisfactory delivery of antipsychotic medication to =80% of groups receiving AP (green), 79-60% of groups receiving AP (amber), < 60% of groups receiving AP (red). Satisfactory delivery of antipsychotic medication will be operationalised as any exposure of AP for 6 consecutive weeks (this would include a dose below BNF lower limits given this is a frequent clinical practice for people of this age and the drugs are licensed for adults). Primary outcome measure as of 03/08/2018: As this is a feasibility trial, a single primary outcome is n

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Secondary

Measure	Time frame
Current secondary outcome measures as of 03/08/2018: All secondary outcomes are being collected to determine their suitability for use in a subsequent trial, rather than to draw conclusions about safety or efficacy of treatments. The proposed primary outcome measure for a subsequent definitive trial will be symptoms of psychosis and schizophrenia assessed using the Positive and Negative Syndrome Scale (PANSS), a commonly used outcome in psychosis trials, allowing comparison with wider evidence. The PANSS will be collected as a secondary outcome for this study and will be administered at baseline and then again at 3 months, 6 months and 12 months’ follow-up. Other secondary outcomes include: 1. Social/educational/occupational functioning, assessed using the First Episode Social Functioning Scale (FESFS) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 2. Self-rated recovery, assessed using the Questionnaire about the Process of Recovery (QPR) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 3. Dimensions of psychotic symptoms, assessed using the Specific Psychotic Experiences Questionnaire (SPEQ) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 4. Adverse effects (weight gain, sexual dysfunction, metabolic effects and extrapyramidal effects) assessed using the antipsychotic non-neurological side effects scale and a full physical health examination (weight, body mass index, waist circumference, blood pressure and fasting estimates of plasma glucose (FPG), HbA1c, lipids and serum prolactin levels) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 5. Common comorbidities, assessed using the Hospital Anxiety and Depression Scale (HADS), the Alcohol Use Disorder Identification Test (AUDIT), the Drug Abuse Screening Test (DAST) and autism spectrum	—

Measure

Time frame

Current secondary outcome measures as of 03/08/2018: All secondary outcomes are being collected to determine their suitability for use in a subsequent trial, rather than to draw conclusions about safety or efficacy of treatments. The proposed primary outcome measure for a subsequent definitive trial will be symptoms of psychosis and schizophrenia assessed using the Positive and Negative Syndrome Scale (PANSS), a commonly used outcome in psychosis trials, allowing comparison with wider evidence. The PANSS will be collected as a secondary outcome for this study and will be administered at baseline and then again at 3 months, 6 months and 12 months’ follow-up. Other secondary outcomes include: 1. Social/educational/occupational functioning, assessed using the First Episode Social Functioning Scale (FESFS) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 2. Self-rated recovery, assessed using the Questionnaire about the Process of Recovery (QPR) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 3. Dimensions of psychotic symptoms, assessed using the Specific Psychotic Experiences Questionnaire (SPEQ) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 4. Adverse effects (weight gain, sexual dysfunction, metabolic effects and extrapyramidal effects) assessed using the antipsychotic non-neurological side effects scale and a full physical health examination (weight, body mass index, waist circumference, blood pressure and fasting estimates of plasma glucose (FPG), HbA1c, lipids and serum prolactin levels) at baseline and then again at 3 months, 6 months and 12 months’ follow-up 5. Common comorbidities, assessed using the Hospital Anxiety and Depression Scale (HADS), the Alcohol Use Disorder Identification Test (AUDIT), the Drug Abuse Screening Test (DAST) and autism spectrum

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Countries

United Kingdom

Contacts

Public ContactMelissa Pyle

Outcome results

None listed