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Completed

NCT Number: NCT02954965

Brief Mood Enhancement 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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Burnout, Professional Burnout, Psychological Occupational Diseases Occupational Stress

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reward

Behavioral

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.

Approach

Behavioral

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Enhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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