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Milestones of Adjustment Post-Psychosis (MAPP)

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ClinicalTrials.gov Identifier: NCT01192594
Recruitment Status : Terminated
First Posted : September 1, 2010
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : November 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: Two years ]
    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 :
  1. Psychological Adjustment Post-Psychosis [ Time Frame: 2 years ]
    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. Quality of Life [ Time Frame: 2 years ]
    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.

  3. Symptom Management [ Time Frame: 2 years ]
    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


Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192594


Locations
United States, Connecticut
The Connection Inc
New Haven, Connecticut, United States, 06511
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: Yale University
ClinicalTrials.gov Identifier: NCT01192594     History of Changes
Other Study ID Numbers: 0906005268
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

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
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders