Milestones of Adjustment Post-Psychosis

NCT ID: NCT01192594

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-01-31

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.

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.

Conditions

Schizophrenia; Quality of Life; Adjustment, Psychological; Medication Adherence; Signs and Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MAPP Trained Case Managers

Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model

Group Type: EXPERIMENTAL

Training in all modules including MAPP Recovery Model

Intervention Type: BEHAVIORAL

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.

Non-MAPP trained case managers

Consumers of case managers not trained in the Milestones of Adjustment Post-Psychosis Recovery Model

Group Type: ACTIVE_COMPARATOR

Training in all modules except MAPP Recovery Model

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

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

• None, all case managers are eligible for the study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary D Moller, DNP

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Locations

The Connection Inc

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

0906005268

Identifier Type: -

Identifier Source: org_study_id