- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954965
Brief Mood Enhancement Intervention
February 21, 2018 updated by: Duke University
Enhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention
The purpose of the current study is to test the efficacy of two brief, behavioral interventions intended to improve burnout among doctoral-level graduate students (n = 102).
Specifically, individuals will be randomly assigned to one of three intervention conditions: 1) Reward: a brief intervention to help participants increase engagement in healthy and rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control condition that involves monitoring only.
Multilevel modeling will be used to assess changes in burnout, mood, and stress, following the interventions, controlling for participants' individual baseline levels of these variables.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently enrolled in any in-person (not online) Ph.D. program in the state of North Carolina
- Demonstrating above average levels of burnout
- Has regular access to the Internet
- Has a Social Security Number
- Is able to read and understand English
Exclusion Criteria:
- Current mania or psychosis
- Current suicidal ideation
- Are currently in psychotherapy, have been in psychotherapy in the past 8 weeks, or are planning to start psychotherapy during the course of the 10-day study
- Have had any changes in psychiatric medications in the past 8 weeks, are not taking medications as prescribed or are planning to change medications during the course of the 10-day study
- Are currently taking benzodiazepines Pro Re Nata (PRN)
- Are under 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reward
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.
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Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are rewarding and pleasurable and to integrate these activities into their schedule.
|
Experimental: Approach
A brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding.
|
Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are challenging, but important to their long-term goals and values, and to integrate these activities into their schedule.
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No Intervention: Monitoring
Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in burnout, as measured by the School Burnout Inventory total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing burnout
|
baseline (day 0) and post-intervention (day 10)
|
Change in stress, as measured by the Perceived Stress Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing stress
|
baseline (day 0) and post-intervention (day 10)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mastery, as measured by the Pearlin Personal Mastery Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaires assessing mastery
|
baseline (day 0) and post-intervention (day 10)
|
Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaires assessing avoidance
|
baseline (day 0) and post-intervention (day 10)
|
Change in mood, as measured by the Positive and Negative Affect Schedule total scores for Positive and Negative Affect
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing mood
|
baseline (day 0) and post-intervention (day 10)
|
Change in reward, as measured by the Environmental Reward Observation Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaires assessing environmental reward
|
baseline (day 0) and post-intervention (day 10)
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Change in behavioral activation, as measured by the Activation sub-scale of the Behavioral Activation for Depression Scale
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaires assessing behavioral activation
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baseline (day 0) and post-intervention (day 10)
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Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing functional impairment
|
baseline (day 0) and post-intervention (day 10)
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Change in quality of life, as measured by the WHOQOL-BREF total score
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing quality of life
|
baseline (day 0) and post-intervention (day 10)
|
Change in depression symptoms, as measured by the General Depression scale of the Inventory of Depression and Anxiety Symptoms
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing depression symptoms
|
baseline (day 0) and post-intervention (day 10)
|
Change in mastery, as measured by the average of the daily Importance ratings of activities (0-10) on the Daily Activities Monitoring Form
Time Frame: baseline (days 0-3) and intervention (days 3-10)
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Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
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baseline (days 0-3) and intervention (days 3-10)
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Change in avoidance, as measured by the total score of the Avoidance/Rumination sub-scale of the Behavioral Activation for Depression Scale
Time Frame: baseline (day 0) and post-intervention (day 10)
|
Self-report questionnaire assessing avoidance and rumination
|
baseline (day 0) and post-intervention (day 10)
|
Change in environmental reward, as measured by the average of the daily Pleasure ratings of activities (0-10) on the Daily Activities Monitoring Form
Time Frame: baseline (days 0-3) and intervention (days 3-10)
|
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
|
baseline (days 0-3) and intervention (days 3-10)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
September 30, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimate)
November 4, 2016
Study Record Updates
Last Update Posted (Actual)
February 23, 2018
Last Update Submitted That Met QC Criteria
February 21, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00074337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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