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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis; Schizophreniform Disorders
• Intervention / Treatment: Behavioral: Individual Placement and Support; Behavioral: Cognitive Remediation Therapy

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual Placement and Support (IPS); IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses.	Behavioral: Individual Placement and Support; 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.
Experimental: Cognitive Remediation Therapy (CRT); 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; This is an evidence based intervention that aims to improve cognitive functioning.
Experimental: IPS and CRT; A combination of IPS and CRT will be provided to participants in this arm.	Behavioral: Individual Placement and Support; 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.; Behavioral: Cognitive Remediation Therapy; This is an evidence based intervention that aims to improve cognitive functioning.
No Intervention: Treatment as usual; Continued input as normal with treating psychiatrist.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 18, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: PILL-IPS&CRT- 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymised data once analysed and published will be available on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No