SchizophreniaNCT03974620
Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia
A study testing Individual Placement and Support and Cognitive Remediation Therapy in people with Schizophrenia and Schizophreniform Disorders, run by Pakistan Institute of Living and Learning.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder
- What is being tested?
- Individual Placement and Support and Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Individual Placement and Support (IPS) and Cognitive Remediation Therapy (CRT) as an Adjunct to Treatment as Usual (TAU) in Patients With Early Schizophrenia Spectrum Disorder: Study Protocol for a Randomized Controlled Feasibility Trial
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.
Read the detailed description
This is an assessor blind, randomised controlled trial, employing a factorial design. This trial aims to assess the feasibility of IPS, CRT or their combination as an add on to treatment as usual. Patients with early schizophrenia spectrum disorder will be recruited from major psychiatric units in Pakistan. Treatment as usual (TAU) will comprise of patient's current antipsychotic medication as prescribed by their responsible clinician. Patients will be randomised into IPS, CRT, their combination or TAU, according to the 2x2 factorial schedule in the table. A total of 30 participants will be recruited in each cell, giving a total of 120 participants.
- Being tested
- Individual Placement and Support, Cognitive Remediation Therapy
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and SupportBehavioural
Individual Placement and Support is a vocational support program that was developed in the USA, to facilitate return to employment in individuals with severe and enduring mental illnesses.
Cognitive Remediation TherapyBehavioural
This is an evidence based intervention that aims to improve cognitive functioning.
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses. Receives: Behavioral: Individual Placement and Support |
| Cognitive Remediation Therapy (CRT) | Experimental | CRT will be delivered twice weekly individual computerised CRT with therapist input. This therapy will be delivered by a CRT trained assistant psychologist. Receives: Behavioral: Cognitive Remediation Therapy |
| IPS and CRT | Experimental | A combination of IPS and CRT will be provided to participants in this arm. Receives: Behavioral: Individual Placement and Support; Behavioral: Cognitive Remediation Therapy |
| Treatment as usual | No intervention | Continued input as normal with treating psychiatrist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates
Recruitment and attrition rates: This will be determined using recruitment and attrition rates into the trial
Measured: 6 month post intervention
Acceptability of the intervention, as determined by: number of sessions attended
Therapy logs: therapy logs with number of sessions attended
Measured: 6 months post intervention
Client Satisfaction Questionnaire (CSQ)
Participants' satisfaction will be measured using CSQ-8. The scale consists of 8 items score range from 8 to 32, with higher values indicating higher satisfaction.
Measured: 6 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974620
- Sponsor's protocol ID
- PILL-IPS&CRT- 001
- Status last verified
- May 2024
- First submitted
- 18 May 2019
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data once analysed and published will be available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Placement and Support (IPS) and Cognitive Remediation Therapy (CRT) as an Adjunct to Treatment as Usual (TAU) in Patients With Early Schizophrenia Spectrum Disorder: Study Protocol for a Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT03974620
- Acronym / sponsor ID
- PILL-IPS&CRT- 001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an assessor blind, randomised controlled trial, employing a factorial design. This trial aims to assess the feasibility of IPS, CRT or their combination as an add on to treatment as usual. Patients with early schizophrenia spectrum disorder will be recruited from major psychiatric units in Pakistan. Treatment as usual (TAU) will comprise of patient's current antipsychotic medication as prescribed by their responsible clinician. Patients will be randomised into IPS, CRT, their combination or TAU, according to the 2x2 factorial schedule in the table. A total of 30 participants will be recruited in each cell, giving a total of 120 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | Behavioral: Individual Placement and SupportIPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses. |
| Cognitive Remediation Therapy (CRT) | Experimental | Behavioral: Cognitive Remediation TherapyCRT will be delivered twice weekly individual computerised CRT with therapist input. This therapy will be delivered by a CRT trained assistant psychologist. |
| IPS and CRT | Experimental | Behavioral: Individual Placement and Support, Behavioral: Cognitive Remediation TherapyA combination of IPS and CRT will be provided to participants in this arm. |
| Treatment as usual | No intervention | –Continued input as normal with treating psychiatrist. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Placement and SupportIndividual Placement and Support is a vocational support program that was developed in the USA, to facilitate return to employment in individuals with severe and enduring mental illnesses. | Behavioural | IPS and CRT, Individual Placement and Support (IPS) |
| Cognitive Remediation TherapyThis is an evidence based intervention that aims to improve cognitive functioning. | Behavioural | Cognitive Remediation Therapy (CRT), IPS and CRT |
Primary outcome
Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates
Time frame: 6 month post intervention
Recruitment and attrition rates: This will be determined using recruitment and attrition rates into the trial
Acceptability of the intervention, as determined by: number of sessions attended
Time frame: 6 months post intervention
Therapy logs: therapy logs with number of sessions attended
Client Satisfaction Questionnaire (CSQ)
Time frame: 6 month post intervention
Participants' satisfaction will be measured using CSQ-8. The scale consists of 8 items score range from 8 to 32, with higher values indicating higher satisfaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No. Anonymised data once analysed and published will be available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement and Support and Cognitive Remediation Therapy in people with Schizophrenia and Schizophreniform Disorders, run by Pakistan Institute of Living and Learning.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates (time frame: 6 month post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.