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

N/ANot Yet RecruitingNCT03974620

Pakistan Institute of Living and Learning120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychosis

Interventions

Individual Placement and SupportBEHAVIORAL

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 TherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 6 month post intervention

Acceptability of the intervention, as determined by: number of sessions attended

Therapy logs: therapy logs with number of sessions attended

Time frame: 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.

Time frame: 6 month post intervention

Data from ClinicalTrials.gov

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