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Medication Adherence in Older People With Psychosis

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What is being tested

Medication Adherence Therapy

+ Friendly Support Group
Behavioral
Who is being recruted

Psychotic Disorders

+ Schizophrenia
Over 40 Years

See all eligibility criteria

How is the trial designed

Other Study

Interventional
Study Start: September 2002

See protocol details

Summary

Principal SponsorVeterans Medical Research Foundation
Last updated: May 6, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2002Actual date on which the first participant was enrolled.

This study will determine whether Medication Adherence Therapy (MAT) can improve medication adherence and lower the risk of rehospitalization in older patients with psychosis. Psychoses are among the most common and serious psychiatric disorders. Currently, the most effective treatment for psychoses involves the use of antipsychotic or neuroleptic medications. Unfortunately, pharmacologic regimens often do not achieve their goals because of poor medication adherence. Nonadherence to antipsychotic treatment is a considerable public health problem that leads to myriad clinical and economic burdens, including psychotic relapse, increased clinic and emergency room visits, and rehospitalization. Participants in this study are randomly assigned to receive either MAT or supportive treatment for 12 weeks. MAT is given in 15 sessions and consists of motivational interviewing, education, and social skills and behavior modification. Individual MAT sessions are held in Weeks 1 and 12; small group sessions take place in Weeks 2 through 11. Three monthly booster group sessions begin in Week 16. Participants are assessed at baseline and at 3, 6, and 12 months. Medication adherence, psychopathology, quality of life, medication side effects, health beliefs, and functioning are assessed.

Official TitleMedication Adherence in Older Psychotic People 
Principal SponsorVeterans Medical Research Foundation
Last updated: May 6, 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
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same 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
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
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
Psychotic Disorders
Schizophrenia
Criteria

Inclusion Criteria: * DSM-IV criteria for schizophrenia or schizoaffective disorder * Outpatient status at the time of enrollment * Currently prescribed maintenance treatment with antipsychotic medication (typical or atypical, oral or depot)

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
Division of Geriatric Psychiatry Center (University of California, San Diego)San Diego, United StatesSee the location
SuspendedOne Study Center