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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2024-12-30

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.

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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.

Conditions

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Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Individual Placement and Support (IPS)

IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses.

Group Type EXPERIMENTAL

Individual Placement and Support

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type BEHAVIORAL

This is an evidence based intervention that aims to improve cognitive functioning.

IPS and CRT

A combination of IPS and CRT will be provided to participants in this arm.

Group Type EXPERIMENTAL

Individual Placement and Support

Intervention Type BEHAVIORAL

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 Therapy

Intervention Type BEHAVIORAL

This is an evidence based intervention that aims to improve cognitive functioning.

Treatment as usual

Continued input as normal with treating psychiatrist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Cognitive Remediation Therapy

This is an evidence based intervention that aims to improve cognitive functioning.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No