Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder, Psychosis
Conditions
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.
Interventions
BEHAVIORALIndividual 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.
BEHAVIORALCognitive Remediation Therapy
This is an evidence based intervention that aims to improve cognitive functioning.
Sponsors
Pakistan Institute of Living and Learning
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates | 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 | 6 months post intervention | Therapy logs: therapy logs with number of sessions attended |
| Client Satisfaction Questionnaire (CSQ) | 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. |
Outcome results
None listed