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CompletedNCT01226329RQP-MHUpdated Jun 3, 2016

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

An interventional study of Right Question Project - Mental Health (RQP-MH) and Pamphlet in Mental Disorders, sponsored by Massachusetts General Hospital. Completed at 13 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-03.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
724
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the detailed description

The intervention is one of two Cambridge Health Alliance (CHA) projects from the University of Puerto Rico-Cambridge Health Alliance Research Center of Excellence (UPR-CHA RCE). The overall goal of the project is to evaluate an intervention that teaches patients a set of skills needed to facilitate a more active patient role in the mental health encounter, emphasizing the patient's decision-making process during mental health treatment. The project also aims to support collaborative provider-patient relationships in order to increase engagement and retention and, consequently, reduce service disparities. The intervention has been pilot-tested in the Right Question Project-Mental Health I (RQP-MH I) study (Alegría, 2008), conducted as part of the UPR-CHA EXPORT Center from September 2004 through February 2006.

The first aim of the current project is to conduct a multi-site randomized controlled trial to test the Patient Activation and Self-Management (PASM) intervention, also called RQP-MH II, in predominantly Latino mental health clinics. The investigators will assess the intervention's impact on engagement and retention in mental health care. The second aim is to explore the racial/ethnic differences in the effect of the RQP-MH II intervention for Latinos as compared to non-Latino whites, as little is known about the impact of patient race/ethnicity on the effectiveness of patient activation interventions. The fourth aim is to explore the role of patient-provider communication and therapeutic alliance as mediators of the relationship between patient activation and engagement and retention in care. It is expected that increased patient-provider communication and a stronger therapeutic alliance will result from increased participation in the decision-making process. These potential changes in the process of care are expected to consequently increase patient engagement (keeping scheduled appointments) and retention (reduction of premature unilateral termination) in mental health care.

Data shows that patients may not readily state their concerns in their medical visits (Roter et al., 1997; Korsch, Gozzi \& Francis, 1968) and usually refrain from engaging in information-seeking (Beisdecker \& Beisdecker, 1990). Minority patients are even less likely than their white counterparts to have a collaborative relationship with providers (Cooper-Patrick et al., 1999). This is a problematic situation particularly for minority patients, such as Latinos, who cherish maintaining a warm personal connection with their providers (American Medical Association, 1994) and may worry that bringing up questions or asking for explanations might jeopardize the relationship.

Minority patients may not be as informed about diagnosis, prognosis, and medication side effects (Schaafsma, Raynor \& de Jong-van den Berg, 2003) and consequently feel disappointed that they do not receive needed information (Levinson et al., 1993). They may therefore be less compliant with treatment (Kalichman et al., 1999), and more likely to drop out of care (Takeuchi et al., 1992). Minority patients may have a less comprehensive understanding of mental health care compared to White patients (Miranda and Cooper, 2004). As a result, they are at a greater risk of assuming that the provider's decisions reflect their best interest (Flynn et al., 2004). This is exemplary of Latinos who hold traditional role expectations that oppose active involvement in the clinical encounter and prefer to delegate decisions about their care to their providers (Levinson et al., 2005; Xu, Borders \& Arif, 2003).

To contend with difficulties in communication, most interventions focus on provider training (Post, Cegala \& Miser, 2002), with less attention on teaching patients how to effectively express their concerns and questions to their providers (Andersen \& Sharpe, 1991; Roter, 1977). Yet results from assessments of self-management of chronic conditions (Hall, Roter \& Katz, 1988; Stewart et al., 1993) indicate that greater patient activation and self-management in treatment can augment satisfaction with care (Blanchard et al., 1990), improve the health care process (Rosenberg, Lussier \& Beaudoin, 1997; Epstein et al., 1993), ensure the receipt of guideline concordant treatments (Clever et al., 2006), and potentially enhance health outcomes (Kaplan, Greenfield \& Ware, 1989).

Most studies of patient activation and self-management in the field of mental health care have not been conducted with minority populations of low literacy nor in a language other than English. Most have not included mixed-methods (qualitative and quantitative) to evaluate the effectiveness of the intervention, and have not obtained cost information that can help evaluate whether changes in patient activation and self-management, or in treatment engagement and retention, could potentially produce savings in treatment or health care outcomes.

The proposed project is expected to fill this gap, assessing the effects of a patient activation and self-management intervention using a mixed-methods approach, with three data collection periods. The investigators hypothesize that patients participating in the patient activation and self-management intervention will be significantly more likely to engage and remain in mental health care, and will report significantly higher activation and self-management scores as compared to control patients. Given the relationship of patient participation and health outcomes, increasing Latino patient's participation in decision-making a as mechanism to eliminate service disparities is the goal of the proposed intervention.

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Conditions studied

  • Mental Disorders

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Keywords

  • Minority Groups
  • Decision Making
  • Patient Participation
  • Mental Health Services
  • retention
  • attendance
  • patient activation
  • Hispanic Americans
  • patient-provider communication
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In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 724 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
724 participants (actual)

Study arms

  • 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)

  • 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

Interventions

  • BehavioralRight 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."

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

  • BehavioralPamphlet

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 30days, 90days

  2. 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.

    Time frame: Baseline, 30days, 90days

  3. Engagement in mental health care

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

    Time frame: Six months following last research interview

  4. 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)

    Time frame: Six months following last research interview

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Study locations

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

Publications

  • 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. PubMed 24647680 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01226329
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Margarita Alegria, PhD (Chief, Disparities Research Unit, Massachusetts General Hospital) — Principal investigator
First posted
Oct 22, 2010
Start date
Jul 2008
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Jun 3, 2016

Study contacts

Margarita Alegria, PhD
principal investigator · Cambridge Health Alliance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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