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NCT03974620 | NOT YET RECRUITING | Schizophrenia

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

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

Schizophrenia

Schizophreniform Disorders

Schizoaffective Disorder

Psychosis

Intervention/treatment

Individual Placement and Support

Cognitive Remediation Therapy

Phase

NA

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 : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
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
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2024-12-30
Estimated Study Completion Date : 2024-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia

Location Details

NCT03974620

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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