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

Schizophrenia Clinical Trial

Official title:

Individual Placement and Support (IPS) and Cognitive Remediation Therapy (CRT) as an Adjunct to Treatment as Usual (TAU) in Patients With Early Schizophrenia Spectrum Disorder: Study Protocol for a Randomized Controlled Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03974620
• Other study ID #: PILL-IPS&CRT- 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorders

Intervention

Behavioral:
• 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.
• Cognitive Remediation Therapy
This is an evidence based intervention that aims to improve cognitive functioning.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability of the intervention, as determined by: number of sessions attended	Therapy logs: therapy logs with number of sessions attended	6 months post intervention
Primary	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