search
Back to results

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

Primary Purpose

Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual Placement and Support
Cognitive Remediation Therapy
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Individual Placement and Support (IPS)

    Cognitive Remediation Therapy (CRT)

    IPS and CRT

    Treatment as usual

    Arm Description

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

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

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

    Continued input as normal with treating psychiatrist.

    Outcomes

    Primary Outcome Measures

    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
    Acceptability of the intervention, as determined by: number of sessions attended
    Therapy logs: therapy logs with number of sessions attended
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2019
    Last Updated
    August 25, 2023
    Sponsor
    Pakistan Institute of Living and Learning
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03974620
    Brief Title
    Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pakistan Institute of Living and Learning

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder, Psychosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individual Placement and Support (IPS)
    Arm Type
    Experimental
    Arm Description
    IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses.
    Arm Title
    Cognitive Remediation Therapy (CRT)
    Arm Type
    Experimental
    Arm Description
    CRT will be delivered twice weekly individual computerised CRT with therapist input. This therapy will be delivered by a CRT trained assistant psychologist.
    Arm Title
    IPS and CRT
    Arm Type
    Experimental
    Arm Description
    A combination of IPS and CRT will be provided to participants in this arm.
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Continued input as normal with treating psychiatrist.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual Placement and Support
    Intervention Description
    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
    Intervention Name(s)
    Cognitive Remediation Therapy
    Intervention Description
    This is an evidence based intervention that aims to improve cognitive functioning.
    Primary Outcome Measure Information:
    Title
    Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates
    Description
    Recruitment and attrition rates: This will be determined using recruitment and attrition rates into the trial
    Time Frame
    6 month post intervention
    Title
    Acceptability of the intervention, as determined by: number of sessions attended
    Description
    Therapy logs: therapy logs with number of sessions attended
    Time Frame
    6 months post intervention
    Title
    Client Satisfaction Questionnaire (CSQ)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Anonymised data once analysed and published will be available on reasonable request.

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs