UnknownNot Applicable

Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia

120 participantsStarted 2024-12-01

Plain-language summary

This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male/Female patients aged between 18-35 years.
. Diagnosis of schizophrenia confirmed by SCID meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
. Stable on medication for the past four weeks.
. In contact with mental health services
. Within 5 years of diagnosis.
. Able to demonstrate the capacity to provide informed consent to take part in this feasibility trial, as assessed by their own clinician.

Exclusion criteria

. Active DSM-V substance abuse (except nicotine or caffeine) or dependence within the last three months
. Relevant CNS or other medical disorders
. Diagnosis of Learning Disability.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates

Timeframe: 6 month post intervention

Acceptability of the intervention, as determined by: number of sessions attended

Timeframe: 6 months post intervention

Client Satisfaction Questionnaire (CSQ)

Timeframe: 6 month post intervention

Trial details

NCT IDNCT03974620

SponsorPakistan Institute of Living and Learning

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male/Female patients aged between 18-35 years.
. Diagnosis of schizophrenia confirmed by SCID meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
. Stable on medication for the past four weeks.
. In contact with mental health services
. Within 5 years of diagnosis.
. Able to demonstrate the capacity to provide informed consent to take part in this feasibility trial, as assessed by their own clinician.

Exclusion criteria

. Active DSM-V substance abuse (except nicotine or caffeine) or dependence within the last three months
. Relevant CNS or other medical disorders
. Diagnosis of Learning Disability.

What they're measuring

Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates

Timeframe: 6 month post intervention

Acceptability of the intervention, as determined by: number of sessions attended

Timeframe: 6 months post intervention

Client Satisfaction Questionnaire (CSQ)

Timeframe: 6 month post intervention