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Milestones of Adjustment Post-Psychosis (MAPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01192594
First received: August 30, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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.

Condition Intervention Phase
Schizophrenia
Quality of Life
Adjustment, Psychological
Medication Adherence
Signs and Symptoms
Behavioral: Training in all modules including MAPP Recovery Model
Behavioral: Training in all modules except MAPP Recovery Model
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Medication Adherence [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Psychological Adjustment Post-Psychosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Symptom Management [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAPP Trained Case Managers
Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model
Behavioral: Training in all modules including MAPP Recovery Model
50% of the case managers will complete all five modules: Disease state,psychopharmacology,symptom management, motivational interviewing and adherence, and the Milestones of Adjustment Post-Psychosis Recovery Model including the MAPP treatment guide.
Active Comparator: Non-MAPP trained case managers
Consumers of case managers not trained in the Milestones of Adjustment Post-Psychosis Recovery Model
Behavioral: Training in all modules except MAPP Recovery Model
50% of the case managers in the study will complete only four training modules: Disease state, psychopharmacology, symptom management, and motivational interviewing and adherence. They will not complete the Milestones of Adjustment Post-Psychosis Recovery Model module.

Detailed Description:

52 psychiatric case managers will receive manualized training in the disease state of schizophrenia, psychotropic medications, motivational interviewing, and relapse prevention. After randomization, 26 case managers will receive additional manualized training in the process of post-psychotic adjustment. Outcomes of 130 consumers (5 per case manager) related to medication adherence, relapse rates, symptom intensity, and quality of life will be evaluated at quarterly intervals over a two-year period. Outcomes of 130 consumers related to medication adherence, relapse rates, symptom intensity, quality of life, and progression through the phases of postpsychotic adjustment (MAPP-Milestones of Adjustment Post-Psychosis Recovery Model) will be evaluated at quarterly intervals via rating scales over a two-year period and the two groups compared.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192594

Contacts
Contact: Mary D Moller, DNP 203-737-1791 mary.moller@yale.edu
Contact: Callie Fentress, BA 508-264-3155 callie.fentress@yale.edu

Locations
United States, Connecticut
The Connection Inc Recruiting
New Haven, Connecticut, United States, 06511
Contact: Jenifer Blemings, MS    203-776-9900 ext 1300    jblemings@theconnectioninc.org   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mary D Moller, DNP Yale University School of Nursing
  More Information

Publications:
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.

Responsible Party: Mary D Moller, Associate Professor, Yale School of Nursing
ClinicalTrials.gov Identifier: NCT01192594     History of Changes
Other Study ID Numbers: 0906005268
Study First Received: August 30, 2010
Last Updated: September 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
symptom management
empowerment
medication adherence
recovery
schizophrenia
post-psychotic adjustment process
psychological adjustment
psychiatric case managers
psychosis
insight
cognitive function

Additional relevant MeSH terms:
Schizophrenia
Signs and Symptoms
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014