Schizophrenia Clinical Trial
— MAPPOfficial title:
Outcomes of Psychiatric Case Manager Training on Medication Adherence, Progression Through the Four Phases of the MAPP Recovery Model, and Quality of Life in Patients With Schizophrenia
Verified date | September 2016 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This nested design clinical outcome study of psychiatric case manager education on disease
state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the
process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis
Recovery Model-MAPP) will test the following hypotheses:
1. Medication non-adherence in patients with schizophrenia assigned to case managers who
receive MAPP training will decrease from their pre-study rate and from the reported
national average after one year enrollment compared to consumers not enrolled in the
MAPP arm of the study.
2. Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and
Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP
at quarterly measures.
3. Consumers enrolled in the MAPP intervention arm of the study will successfully complete
the first two phases of the MAPP Recovery Model in one year.
4. Consumers in the MAPP intervention arm will have greater symptom reductions at
quarterly data points compared to consumers not enrolled in the MAPP intervention arm.
Status | Terminated |
Enrollment | 110 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria:Case Managers - Voluntary basis-includes willingness to administer study tools quarterly for two years to at least five consumers from their assigned caseloads and to keep a log of their activities and reactions. Inclusion Criteria for consumer subjects: 130 in each treatment arm 1. A diagnosis of a schizophrenia spectrum disorder as defined by DSMIV TR (63) 2. Males and females at least 21 years of age assigned to case managers 3. Able to understand the requirements of the study Exclusion Criteria:Case Managers - None, all case managers are eligible for the study Exclusion Criteria: Consumers - Any DSM-IV Axis I disorder not defined in the inclusion criteria |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | The Connection Inc | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Moller, M.D. (2009). Neurobiological responses and schizophrenia and psychotic disorders. In, Stuart, G. Principles and practices of psychiatric nursing, 9th Ed. Chapter 20/ St. Louis: Mosby.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medication Adherence | Specific consumer medication adherence outcome data will be collected quarterly for both groups for two years targeting two specific analyses of change: pharmacy records of prescription refills one year before and quarterly after the educational intervention. These records will be obtained by informed consent from the consumer and respective pharmacies. | Two years | Yes |
Secondary | Psychological Adjustment Post-Psychosis | Movement through the four phases of the MAPP: cognitive dissonance, insight, cognitive constancy, and ordinariness and resolution of stage specific themes will be evaluated quarterly for both years of the study and analyzed using latent transitional analysis | 2 years | No |
Secondary | Quality of Life | The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-Les-Q) will be administered quarterly to consumers in both arms of the study over two years. | 2 years | No |
Secondary | Symptom Management | Symptoms associated with anxiety, depression, psychosis, mania,cognitive difficulties, activities of daily living, medication adherence, interpersonal relationships, general health concerns, and common symptom management strategies will be measured quarterly using the Moller-Murphy Symptom Management Assessment Tool | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |