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

Pakistan Institute of Living and Learning

Status: Not yet enrolling

Conditions: Schizophreniform Disorders; Psychosis; Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Cognitive Remediation Therapy; Behavioral: Individual Placement and Support

Study type: Interventional

Funder types: Other

Identifiers

NCT03974620

PILL-IPS&CRT- 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Individual Placement and Support (IPS)

Experimental group

Description:

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

Treatment:

Behavioral: Individual Placement and Support

Cognitive Remediation Therapy (CRT)

Experimental group

Description:

CRT will be delivered twice weekly individual computerised CRT with therapist input. This therapy will be delivered by a CRT trained assistant psychologist.

Treatment:

Behavioral: Cognitive Remediation Therapy

IPS and CRT

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Remediation Therapy

Behavioral: Individual Placement and Support

Treatment as usual

No Intervention group

Description:

Continued input as normal with treating psychiatrist.