Brief Mood Enhancement Intervention

ID: NCT02954965
Status: Completed
Phase: N/A
Start Date: November 01, 2016
First Submitted: September 30, 2016
Last Updated: February 21, 2018
Results: N/A
Organization: Duke University
Sponsors & Collaborators: Duke University
Location: United States
Conditions: Stress, Psychological, Burnout, Professional
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Burnout, Professional

Stress, Psychological

Behavioral: Reward
Other Names
Behavioral: Approach
Other Names
N/A

Tracking Information

First Submitted DateSeptember 30, 2016
Last Update Posted DateFebruary 21, 2018
Start DateNovember 01, 2016
Actual Completion DateDecember 01, 2017
Primary Completion DateDecember 01, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

  • 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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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)]

    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 [Time Frame: baseline (day 0) and post-intervention (day 10)]

    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 [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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleBrief Mood Enhancement Intervention
Official TitleEnhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
66
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Burnout, Professional
Stress, Psychological
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: Reward

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.

Other Names
Behavioral: Approach

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.

Other Names
Study Groups/Cohorts
Reward
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.

Approach
A brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding.

Monitoring
Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior

Study Arms
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.
Behavioral : Approach
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.

Experimental Reward
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.
Behavioral : Reward
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.

Arm Intervention/Treatment
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.
Behavioral : Approach
Experimental Reward
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.
Behavioral : Reward

Recruitment Information

Recruitment Status:Completed
Enrollment66
Completion DateDecember 01, 2017
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
GenderAll
Age18 Years to 60 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02954965
Other Study ID Numbers
PRO00074337
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Duke University
Collaborators
Not Available
Investigators
Not Available