NCT02146326

Brief Summary

Healthcare providers play an important role in helping patients be actively involved in treatment and recover from mental illness. But mental health clinicians, like other healthcare providers, are at risk for experiencing burnout-feeling emotionally drained from their work, having cynical thoughts toward patients and others, and feeling little accomplishment in their work. Burnout can lead to problems for the clinician including poor overall health, depression, and lower job satisfaction. Burnout also can impact how clinicians perform on the job; for example, people with high levels of burnout take more time off, show lower commitment to their job, and are more likely to quit or be fired. There is some evidence that burnout can affect the quality of care for patients, but very little rigorous research has tested this assumption. The purpose of our study is threefold. First, we will investigate how patients perceive burnout in clinicians and whether (and/or how) burnout impacts the care they receive. Next, we will test an intervention to reduce clinician burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE). BREATHE brings together tools that mental health clinicians are already familiar with, including relaxation and mindfulness exercises, setting boundaries, using social supports, and changing negative thought patterns and replacing them with more helpful ways of thinking. We have found this intervention effective in reducing burnout in other organizations, but have yet to study whether it also can improve patient outcomes. Clinicians (approximately 200) who participate will receive either the BREATHE intervention or training in motivational interviewing, which could also improve patient involvement in treatment and patient outcomes, but is unlikely to significantly reduce clinician burnout. We will also recruit up to 600 adult patients served by participating clinicians. We will survey clinicians and interview patients over a 12-month period after the intervention to determine how the intervention impacts clinician burnout and patient perceptions of care (relationship with the clinician, degree of autonomy in decision making), patient involvement in care, and outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally, this study will use a statistical procedure called Structural Equation Modeling to test a theoretical model of the relationship between burnout and patient outcomes. Findings from this study will show whether reducing clinician burnout can improve patient outcomes and the quality of care that patients receive. Our intervention will have the potential to be easily implemented in a variety of settings where burnout is a problem. Knowing how clinician burnout impacts patient outcomes, and whether improving burnout can improve patient care, can help improve the healthcare system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
679

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 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

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 14, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

May 21, 2014

Results QC Date

April 11, 2017

Last Update Submit

April 11, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maslach Burnout Inventory (MBI): Emotional Exhaustion

    Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • Maslach Burnout Inventory (MBI): Depersonalization

    Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • Maslach Burnout Inventory (MBI): Personal Accomplishment

    Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.

    Measured with staff at baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (36)

  • Job Satisfaction

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • Turnover Intentions-Considered Leaving

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • Turnover Intentions-Likely to Leave

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • Work Interference With Home Life

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • Home Life Interference With Work

    Measured with staff at baseline, 3 months, 6 months, and 12 months

  • +31 more secondary outcomes

Study Arms (4)

Motivational Interviewing-Mental Health Staff

ACTIVE COMPARATOR
Behavioral: Motivational Interviewing (MI)

BREATHE-Mental Health Staff

ACTIVE COMPARATOR
Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)

Motivational Interviewing-Clients

ACTIVE COMPARATOR
Behavioral: Motivational Interviewing (MI)

BREATHE-Clients

ACTIVE COMPARATOR
Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)

Interventions

MI is a common counseling technique. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to MI. Each session occurred approximately one month apart.

Motivational Interviewing-ClientsMotivational Interviewing-Mental Health Staff

BREATHE is a program developed to attempt to improve or prevent the symptoms of burnout. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to BREATHE. Each session occurred approximately one month apart.

BREATHE-ClientsBREATHE-Mental Health Staff

Eligibility Criteria

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

You may qualify if:

  • A staff member with client contact at either Four County Counseling or Places for People.
  • Randomly chosen client from the participating staff lists. Must be 18 years old or older.

You may not qualify if:

  • Clients younger than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Four County Counseling Center

Logansport, Indiana, 46947, United States

Location

Places for People

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Motivational InterviewingEducational Status

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Limitations and Caveats

Absence of treatment as usual condition, high staff turnover, and difficulty linking patients with specific clinicians with whom they had meaningful contact

Results Point of Contact

Title
Michelle Salyers, PhD / Professor, Department of Psychology
Organization
Indiana University

Study Officials

  • Michelle P Salyers, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Psychology

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

April 14, 2017

Results First Posted

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations