NCT01226329

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
724

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

3.3 years

First QC Date

September 16, 2010

Last Update Submit

June 2, 2016

Conditions

Keywords

Minority GroupsDecision MakingPatient ParticipationMental Health Servicesretentionattendancepatient activationHispanic Americanspatient-provider communication

Outcome Measures

Primary Outcomes (4)

  • Patient Activation

    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.

    Baseline, 30days, 90days

  • Patient Self-Management

    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.

    Baseline, 30days, 90days

  • Engagement in mental health care

    Scheduling and keeping mental health treatment appointments over a six month period after finishing the final research interview.

    Six months following last research interview

  • Retention in mental health treatment

    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)

    Six months following last research interview

Study Arms (2)

RQP-MH

EXPERIMENTAL

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)

Comparison Group

ACTIVE COMPARATOR

Participants in this arm will receive a pamphlet in either Spanish or English called "Managing Your Mental Health Care."

Behavioral: Pamphlet

Interventions

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."

Also known as: Patient Activation and Self-Management (PASM) intervention
RQP-MH
PamphletBEHAVIORAL

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.

Comparison Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Martha Eliot Health Center

Jamaica Plain, Massachusetts, 02130, United States

Location

Cambridge Health Alliance (Malden Family Medicine Center)

Malden, Massachusetts, 02148, United States

Location

Cambridge Health Alliance (Central Street Health Center)

Somerville, Massachusetts, 02143, United States

Location

Edward M Kennedy Health Center (Great Brook Valley Health Center)

Worcester, Massachusetts, 01605, United States

Location

Community-University Health Care Center

Minneapolis, Minnesota, 55404, United States

Location

Hamm Memorial Psychiatric Clinic

Saint Paul, Minnesota, 55102, United States

Location

West Side Community Health Services - La Clinica

Saint Paul, Minnesota, 55107, United States

Location

University Behavioral Healthcare

New Brunswick, New Jersey, 08901, United States

Location

Columbia University Medical Center, Outpatient Psychiatry Program

New York, New York, 10032, United States

Location

El Futuro Clinic, Carrboro site

Carrboro, North Carolina, 27510, United States

Location

El Futuro Clinic, Durham site

Durham, North Carolina, 27701, United States

Location

Clinica de Salud Mental de la Comunidad Universidad Carlos Albizu

San Juan, 00901, Puerto Rico

Location

Related Publications (1)

  • Alegria M, Carson N, Flores M, Li X, Shi P, Lessios AS, Polo A, Allen M, Fierro M, Interian A, Jimenez A, La Roche M, Lee C, Lewis-Fernandez R, Livas-Stein G, Safar L, Schuman C, Storey J, Shrout PE. Activation, self-management, engagement, and retention in behavioral health care: a randomized clinical trial of the DECIDE intervention. JAMA Psychiatry. 2014 May;71(5):557-65. doi: 10.1001/jamapsychiatry.2013.4519.

Related Links

MeSH Terms

Conditions

Mental DisordersPatient Participation

Interventions

Self-ManagementMethods

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesInvestigative Techniques

Study Officials

  • Margarita Alegria, PhD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Disparities Research Unit

Study Record Dates

First Submitted

September 16, 2010

First Posted

October 22, 2010

Study Start

July 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations