Completed

Rehabilitative Training for Older People With Schizophrenia

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What is being tested

Functional Adaptation Skills Training (FAST)

Behavioral
Who is being recruted

Schizophrenia

Over 40 Years
How is the trial designed

Other Study

Phase 2
Interventional
Study Start: July 2001

Summary

Principal SponsorUniversity of California, San Diego
Last updated: June 14, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2001Actual date on which the first participant was enrolled.

This study will evaluate the effectiveness of a rehabilitation program called Functional Adaptation Skills Training (FAST) in treating older patients with schizophrenia. People with schizophrenia often have problems functioning in everyday life. As people with schizophrenia get older, resources for effective health care and social services may become more limited. There is a need to develop effective rehabilitation programs that are sensitive to the special needs of older persons with schizophrenia. Patients are randomly assigned to either 1 of 2 groups. The FAST group will involve 24 sessions of group intervention designed to enhance daily functioning of older patients with schizophrenia. The placebo group will involve participation in a psychosocial support group for an equivalent amount of time. Treatment is followed by 6 monthly maintenance sessions. Patients will be assessed at 6, 12, and 18 months after the study start. Assessments include clinical and functional measures.

Official TitleFunctional Skills Training for Late Life Schizophrenia 
Principal SponsorUniversity of California, San Diego
Last updated: June 14, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
240 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Schizophrenia
Criteria

Inclusion Criteria: * Have schizophrenia or schizoaffective disorder



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of California, San DiegoLa Jolla, United StatesSee the location

CompletedOne Study Center