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出境医 / 临床实验 / Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia

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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychosis Behavioral: Individual Placement and Support Behavioral: Cognitive Remediation Therapy Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Individual Placement and Support (IPS)
IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses.
 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.
Experimental: Cognitive Remediation Therapy (CRT)
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
This is an evidence based intervention that aims to improve cognitive functioning.
Experimental: IPS and CRT
A combination of IPS and CRT will be provided to participants in this arm.
 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.

Behavioral: Cognitive Remediation Therapy
This is an evidence based intervention that aims to improve cognitive functioning.
No Intervention: Treatment as usual
Continued input as normal with treating psychiatrist.
Outcome Measures
Primary Outcome Measures :
  1. Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates [ Time Frame: 6 month post intervention ]
    Recruitment and attrition rates: This will be determined using recruitment and attrition rates into the trial

  2. Acceptability of the intervention, as determined by: number of sessions attended [ Time Frame: 6 months post intervention ]
    Therapy logs: therapy logs with number of sessions attended

  3. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 6 month post intervention ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 18, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates [ Time Frame: 6 month post intervention ]
    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 [ Time Frame: 6 months post intervention ]
    Therapy logs: therapy logs with number of sessions attended
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: 6 month post intervention ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizophreniform Disorders
  • Schizoaffective Disorder
  • Psychosis
Intervention  ICMJE
  • 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.
  • Behavioral: Cognitive Remediation Therapy
    This is an evidence based intervention that aims to improve cognitive functioning.
Study Arms  ICMJE
  • Experimental: Individual Placement and Support (IPS)
    IPS is a vocational support program to facilitate return to employment in individuals with severe and enduring mental illnesses.
    Intervention: Behavioral: Individual Placement and Support
  • Experimental: Cognitive Remediation Therapy (CRT)
    CRT will be delivered twice weekly individual computerised CRT with therapist input. This therapy will be delivered by a CRT trained assistant psychologist.
    Intervention: Behavioral: Cognitive Remediation Therapy
  • Experimental: IPS and CRT
    A combination of IPS and CRT will be provided to participants in this arm.
    Interventions:
    • Behavioral: Individual Placement and Support
    • Behavioral: Cognitive Remediation Therapy
  • No Intervention: Treatment as usual
    Continued input as normal with treating psychiatrist.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974620
Other Study ID Numbers  ICMJE PILL-IPS&CRT- 001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Anonymised data once analysed and published will be available on reasonable request.
Responsible Party Pakistan Institute of Living and Learning
Study Sponsor  ICMJE Pakistan Institute of Living and Learning
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pakistan Institute of Living and Learning
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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