The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care (RQP-MH)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT01226329
First received: September 16, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

The Right Question Project-Mental Health (RQP-MH) is a three-session health education intervention that teaches clients to participate effectively in mental health care. The methodology teaches clients to identify important issues of their illness or treatment, formulate questions, and devise plans to communicate and act in effective ways that address factors impacting their mental health care, with the expectation that this behavior will increase patient-provider communication and improve the therapeutic alliance between patient and provider.

The investigators hypothesize that participants receiving the intervention will be more likely to engage and remain in mental health care, and that they will report higher activation and self-management scores as compared to control patients.


Condition Intervention
Mental Disorders
Behavioral: Right Question Project - Mental Health (RQP-MH)
Behavioral: Pamphlet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care

Resource links provided by NLM:


Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Patient Activation [ Time Frame: Baseline, 30days, 90days ] [ Designated as safety issue: No ]
    Activation is defined as a behavior change approach that includes an individual's acquisition of knowledge, skills and beliefs to take thoughtful action on one's own behalf and actively participate in questions and decisions about one's health and health care treatment.

  • Patient Self-Management [ Time Frame: Baseline, 30days, 90days ] [ Designated as safety issue: No ]
    Self-management focuses on patients gaining knowledge and self-efficacy to better manage their mental health condition and developing awareness of the factors that hinder or enhance their mental health outcomes.

  • Engagement in mental health care [ Time Frame: Six months following last research interview ] [ Designated as safety issue: No ]
    Scheduling and keeping mental health treatment appointments over a six month period after finishing the final research interview.

  • Retention in mental health treatment [ Time Frame: Six months following last research interview ] [ Designated as safety issue: No ]
    Attending four or more treatment sessions during the six month period after the final research interview (or completed treatment as designated in the medical record)


Enrollment: 724
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RQP-MH
Participants in the intervention arm will receive three Patient Activation and Self-Management education sessions, plus a fourth booster session if they show difficulty mastering the content of the first three trainings.
Behavioral: Right Question Project - Mental Health (RQP-MH)
The RQP-MH trainings each take approximately 45 minutes to complete and are delivered approximately three weeks apart. The manualized intervention uses a Question Formulation Technique (QFT) and a Framework for Active Decision-Making (FADM). The QFT consists of asking patients to generate and revise questions to obtain more informative answers from their providers. The FADM teaches participants to identify questions that will help them consider their role in a decision, the process of decision-making, and the reasons behind a decision. All intervention sessions will be taught by a bachelors-level "Care Manager."
Other Name: Patient Activation and Self-Management (PASM) intervention
Active Comparator: Comparison Group
Participants in this arm will receive a pamphlet in either Spanish or English called "Managing Your Mental Health Care."
Behavioral: Pamphlet
Participants in this group receive a handout called "Managing Your Mental Health" (available in Spanish and English) that provides tips on how to manage mental health through the proper maintenance of physical health and stress.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between ages of 18 and 70 (patients above age 65 will be administered the Mini-Cog, a cognitive impairment screener)
  • speak English and/or Spanish
  • currently receiving outpatient mental health care

Exclusion Criteria:

  • suicidal ideation or attempt within the past four weeks
  • lacks capacity to consent (adapted from Zayas, Cabassa, & Perez, 2005)
  • only receiving services that are strictly case-management
  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: NCT01226329

Locations
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
Martha Eliot Health Center
Jamaica Plain, Massachusetts, United States, 02130
Cambridge Health Alliance (Malden Family Medicine Center)
Malden, Massachusetts, United States, 02148
Cambridge Health Alliance (Central Street Health Center)
Somerville, Massachusetts, United States, 02143
Edward M Kennedy Health Center (Great Brook Valley Health Center)
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Community-University Health Care Center
Minneapolis, Minnesota, United States, 55404
West Side Community Health Services - La Clinica
St Paul, Minnesota, United States, 55107
Hamm Memorial Psychiatric Clinic
St Paul, Minnesota, United States, 55102
United States, New Jersey
University Behavioral Healthcare
New Brunswick, New Jersey, United States, 08901
United States, New York
Columbia University Medical Center, Outpatient Psychiatry Program
New York, New York, United States, 10032
United States, North Carolina
El Futuro Clinic, Carrboro site
Carrboro, North Carolina, United States, 27510
El Futuro Clinic, Durham site
Durham, North Carolina, United States, 27701
Puerto Rico
Clinica de Salud Mental de la Comunidad Universidad Carlos Albizu
San Juan, Puerto Rico, 00901
Sponsors and Collaborators
Cambridge Health Alliance
Investigators
Principal Investigator: Margarita Alegria, PhD Cambridge Health Alliance
  More Information

Additional Information:
No publications provided by Cambridge Health Alliance

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT01226329     History of Changes
Other Study ID Numbers: CHA-IRB00329/07/08, P60MD002261-03
Study First Received: September 16, 2010
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cambridge Health Alliance:
Minority Groups
Decision Making
Patient Participation
Mental Health Services
retention
attendance
patient activation
Hispanic Americans
patient-provider communication

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

ClinicalTrials.gov processed this record on September 18, 2014