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

NCT03974620 | Not Yet Recruiting

• 1 other identifier: PILL-IPS&CRT- 001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Psychosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Individual Placement and Support (IPS)

EXPERIMENTAL

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

Behavioral: Individual Placement and Support

Cognitive Remediation Therapy (CRT)

EXPERIMENTAL

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

IPS and CRT

EXPERIMENTAL

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

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

Treatment as usual

NO INTERVENTION

Continued input as normal with treating psychiatrist.

Interventions

Individual Placement and Support 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.

IPS and CRT; Individual Placement and Support (IPS)

Cognitive Remediation Therapy BEHAVIORAL

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

Cognitive Remediation Therapy (CRT); IPS and CRT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2019
• First Posted: June 5, 2019
• Study Start: December 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share