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

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ClinicalTrials.gov Identifier: NCT03974620
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.



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.



Information from the National Library of Medicine

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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.

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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT03974620     History of Changes
Other Study ID Numbers: PILL-IPS&CRT- 001
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymised data once analysed and published will be available on reasonable request.

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

Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders