Back to resultsBrief Mood Enhancement Intervention
Primary Purpose
Stress, Psychological, Burnout, Professional
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reward
Approach
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring graduate student, burnout, stress, mood
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Reward
Approach
Monitoring
Arm Description
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.
A brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding.
Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior
Outcomes
Primary Outcome Measures
Change in burnout, as measured by the School Burnout Inventory total score
Self-report questionnaire assessing burnout
Change in stress, as measured by the Perceived Stress Scale total score
Self-report questionnaire assessing stress
Secondary Outcome Measures
Change in mastery, as measured by the Pearlin Personal Mastery Scale total score
Self-report questionnaires assessing mastery
Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score
Self-report questionnaires assessing avoidance
Change in mood, as measured by the Positive and Negative Affect Schedule total scores for Positive and Negative Affect
Self-report questionnaire assessing mood
Change in reward, as measured by the Environmental Reward Observation Scale total score
Self-report questionnaires assessing environmental reward
Change in behavioral activation, as measured by the Activation sub-scale of the Behavioral Activation for Depression Scale
Self-report questionnaires assessing behavioral activation
Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score
Self-report questionnaire assessing functional impairment
Change in quality of life, as measured by the WHOQOL-BREF total score
Self-report questionnaire assessing quality of life
Change in depression symptoms, as measured by the General Depression scale of the Inventory of Depression and Anxiety Symptoms
Self-report questionnaire assessing depression symptoms
Change in mastery, as measured by the average of the daily Importance ratings of activities (0-10) on the Daily Activities Monitoring Form
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
Change in avoidance, as measured by the total score of the Avoidance/Rumination sub-scale of the Behavioral Activation for Depression Scale
Self-report questionnaire assessing avoidance and rumination
Change in environmental reward, as measured by the average of the daily Pleasure ratings of activities (0-10) on the Daily Activities Monitoring Form
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02954965
Brief Title
Brief Mood Enhancement Intervention
Official Title
Enhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Burnout, Professional
Keywords
graduate student, burnout, stress, mood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reward
Arm Type
Experimental
Arm Description
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.
Arm Title
Approach
Arm Type
Experimental
Arm Description
A brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding.
Arm Title
Monitoring
Arm Type
No Intervention
Arm Description
Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior
Intervention Type
Behavioral
Intervention Name(s)
Reward
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in burnout, as measured by the School Burnout Inventory total score
Description
Self-report questionnaire assessing burnout
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in stress, as measured by the Perceived Stress Scale total score
Description
Self-report questionnaire assessing stress
Time Frame
baseline (day 0) and post-intervention (day 10)
Secondary Outcome Measure Information:
Title
Change in mastery, as measured by the Pearlin Personal Mastery Scale total score
Description
Self-report questionnaires assessing mastery
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score
Description
Self-report questionnaires assessing avoidance
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in mood, as measured by the Positive and Negative Affect Schedule total scores for Positive and Negative Affect
Description
Self-report questionnaire assessing mood
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in reward, as measured by the Environmental Reward Observation Scale total score
Description
Self-report questionnaires assessing environmental reward
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in behavioral activation, as measured by the Activation sub-scale of the Behavioral Activation for Depression Scale
Description
Self-report questionnaires assessing behavioral activation
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score
Description
Self-report questionnaire assessing functional impairment
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in quality of life, as measured by the WHOQOL-BREF total score
Description
Self-report questionnaire assessing quality of life
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in depression symptoms, as measured by the General Depression scale of the Inventory of Depression and Anxiety Symptoms
Description
Self-report questionnaire assessing depression symptoms
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in mastery, as measured by the average of the daily Importance ratings of activities (0-10) on the Daily Activities Monitoring Form
Description
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
Time Frame
baseline (days 0-3) and intervention (days 3-10)
Title
Change in avoidance, as measured by the total score of the Avoidance/Rumination sub-scale of the Behavioral Activation for Depression Scale
Description
Self-report questionnaire assessing avoidance and rumination
Time Frame
baseline (day 0) and post-intervention (day 10)
Title
Change in environmental reward, as measured by the average of the daily Pleasure ratings of activities (0-10) on the Daily Activities Monitoring Form
Description
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
Time Frame
baseline (days 0-3) and intervention (days 3-10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Brief Mood Enhancement Intervention
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