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The EXTEND trial: evaluating the effectiveness of extended early intervention for psychosis treatment

Extended treatment in early intervention in psychosis services: randomized controlled trial, mixed methods sub-study and health economic analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13235578
Enrollment
1092
Registered
2020-09-29
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals with psychosis who are have recieved 2.5 years of treatment by Early Intervention in Psychosis (EIP) services Mental and Behavioural Disorders Unspecified nonorganic psychosis

Interventions

Participants will be randomized (1:1) to extended early intervention or treatment as usual (discharged to either primary care or a community mental health team). Participants will be between 30 and 32

Sponsors

Pennine Care NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals who have completed 2.5 years of EIP treatment

Exclusion criteria

Exclusion criteria: 1. People who are unable to receive community treatment, because they are admitted to forensic inpatient units or have been a hospital inpatient for a year or more at time of recruitment 2. Inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Relapse rate, defined as admission to a psychiatric hospital or acceptance to the caseload of a service designated as a hospital alternative, including crisis resolution team, crisis house, home treatment team, or other acute mental health service. Collected using medical records at 30-month and 42-month follow-up.

Secondary

MeasureTime frame
1. Recovery-focused quality of life measured using Recovering Quality of Life (REQoL), collected via research interview at baseline and 42-month follow-up 2. Quality-adjusted life-years (QALYs) calculated using EQ-5D, collected via research interview at baseline and 42-month follow-up 3. Subjective recovery from psychosis measured using questionnaire about the Process of Recovery (QPR), collected via research interview at baseline and 42-month follow-up 4. Service utilisation, income, accommodation and other cost-related variables measured using Client Service Receipt Inventory (CSRI), collected via research interview at baseline and 42-month follow-up 5. Number Not in Education, Employment or Training (NEET) status, collected via research interview at baseline and 42-month follow-up 6. Time to relapse, defined as per the primary outcome measure, collected using medical records at 30-month and 42-month follow-up 7. Number of days in psychiatric hospital, collected using medical records at baseline, 30-month and 42-month follow-up 8. Disengagement from services, collected using medical records at 30-month and 42-month follow-up 9. All-cause mortality, collected using national mortality records at 30-month and 42-month follow-up

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026