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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder, Psychosis

Intervention / Treatment
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* Behavioral: Individual Placement and Support
* Behavioral: Cognitive Remediation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Placement and Support (IPS)<br>IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses. | Behavioral: Individual Placement and Support<br>* 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.<br>|
| Experimental: Cognitive Remediation Therapy (CRT)<br>CRT will be delivered twice weekly individual computerised CRT with therapist input. This therapy will be delivered by a CRT trained assistant psychologist. | Behavioral: Cognitive Remediation Therapy<br>* This is an evidence based intervention that aims to improve cognitive functioning.<br>|
| Experimental: IPS and CRT<br>A combination of IPS and CRT will be provided to participants in this arm. | Behavioral: Individual Placement and Support<br>* 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.<br>Behavioral: Cognitive Remediation Therapy<br>* This is an evidence based intervention that aims to improve cognitive functioning.<br>|
| No Intervention: Treatment as usual<br>Continued input as normal with treating psychiatrist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 month post intervention | 
| Acceptability of the intervention, as determined by: number of sessions attended | Therapy logs: therapy logs with number of sessions attended | 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. | 6 month post intervention |