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

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia; Psychosis; Schizophreniform Disorders; Schizoaffective Disorder
• Interventions: Behavioral: Cognitive Remediation Therapy; Behavioral: Individual Placement and Support

• Registration Number: NCT03974620
• Lead Sponsor: Pakistan Institute of Living and Learning

Brief 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.

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 Timeline

• Study First Submitted: 2019-05-18
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Study Start: 2024-12-01
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation Therapy (CRT)	Cognitive Remediation Therapy	CRT 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	Individual Placement and Support	A combination of IPS and CRT will be provided to participants in this arm.
Individual Placement and Support (IPS)	Individual Placement and Support	IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses.
IPS and CRT	Cognitive Remediation Therapy	A combination of IPS and CRT will be provided to participants in this arm.

Primary Outcome Measures

Name	Time	Method
Acceptability of the intervention, as determined by: number of sessions attended	6 months post intervention	Therapy logs: therapy logs with number of sessions attended
Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates	6 month post intervention	Recruitment and attrition rates: This will be determined using recruitment and attrition rates into the trial
Client Satisfaction Questionnaire (CSQ)	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.